ePRO tools in early-phase trials: implications and outlook

Managing long-term toxicities, defining dose-limiting toxicities (DLTs), detecting adverse events: how can ePRO tools reshape early-phase trials?

Dec 3, 2025

5 minutes

For years, early-phase clinical trials focused almost exclusively on short-term dose-limiting toxicities (DLTs). That is starting to change. Today, researchers are adopting a broader, more continuous approach to monitoring treatment-related toxicities.

This is where electronic patient-reported outcomes (ePROs) come in. By capturing real‑time patient feedback on treatment tolerance, ePROs can uncover signs and symptoms that might otherwise go unnoticed¹–³ — and even help refine how DLTs are defined. Ultimately, these insights could reshape a more comprehensive approach to patient care.

We interviewed Prof. Christophe Massard, medical oncologist, Head of the Department of Therapeutic Innovation and Early Trials (DITEP) at Gustave Roussy, and Professor at Université Paris-Saclay, who shared his perspective during our conference “Digital Innovation in Oncology Clinical Research.” We are grateful to him for taking the time to share his reflections on this important topic.

‍

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

Until recently, phase I and II trials were focusing on DLTs observed in the first days or weeks of treatment. But over the past decade, mindsets have shifted. There’s now real awareness of the need to track toxicity over the long term.

A big part of this is due to targeted therapies, which have transformed outcomes for many patients. These drugs often cause few early DLTs but significant delayed toxicities. Immunotherapies have further changed the picture: their toxicities can surface weeks or even months after initiation. Several studies show that over half of severe toxicities now occur after the first cycle.

On top of that, the FDA has recently called for the integration of the Optimus Design in phase I trials, pushing for dose optimization earlier in development — without waiting for phase II or III. As a result, most current phase I studies now explore multiple dosing levels in light of varying toxicity profiles.

Phase I trials are no longer just about identifying the maximum tolerated dose. Increasingly — especially through cohort expansions — the goal is to define the optimal* dose. This is where PRO data can play a decisive role: by capturing patient-reported toxicities, they can inform dose recommendations for phase II and III, and ultimately help prevent late-stage trial failures caused by poor dose selection.

‍

*Optimal: great balance between efficacy and toxicity, increased focus on tolerability

‍

What value do ePROs add in early-phase trials?

Bringing ePROs in phase I and II trials has three clear benefits:

1. Sharper dose definition. They can help fine-tune what counts as a DLT and inform the recommended dose.

2. Better detection of undetected and underestimated side effects. Publications have shown that clinicians often underestimate certain adverse events, particularly gastrointestinal, cognitive, or sexual adverse events. ePROs capture symptomatic toxicities directly from patients, surfacing issues that might otherwise only emerge and be noticed in later phases, or even post-approval in real-world use¹–³.

3. Continuous monitoring. In early-phase trial, patients are typically seen weekly, biweekly, or monthly, and often do not report all side effects between two visits. ePROs allow near real-time capture of weak signals that may herald more serious toxicities — enabling earlier intervention

‍

How does the use of ePROs reflect a broader shift in trial design?

Traditionally, phases I, II, and III were seen as separate silos. Now, with Optimus Design, the goal is a continuum: optimization is pursued throughout drug development —ensuring that the dose administered in phase III and real-world settings is truly the most appropriate.

Trial designs have long been anchored in the framework of traditional chemotherapy. But with the advent of next-generation agents — especially antibody-drug conjugates — distinct patterns of toxicity are coming to light. I strongly believe that ePROs will be key to capturing these signals and defining the optimal dosing of such therapies.

To use a metaphor: not leveraging ePROs is like driving a Formula 1 car on a country road. Today’s therapies are our Formula 1 cars; to harness their full potential, we need the right “track”—tools that can precisely capture, characterize, and track patient-reported toxicities

So the real value of PROs and ePROs lies in their ability to optimize dosing?

Exactly. The objective isn’t to push for the highest tolerable dose, but to identify the optimal dose depending on the drug and its mechanism of action. We now recognize the need for different treatment regimens⁴,⁵ — including intermittent schedules with high doses given over just a few days. ePROs will be crucial in modeling and validating these approaches.

‍

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Traditionally, phase I studies focused on the first month — or at most the first two months — of treatment. But over the past decade, we’ve learned that grade I and II adverse events, while not severe individually, accumulate over time and significantly impact patients⁶,⁷. ePROs give us a more complete picture of these cumulative toxicities.

They also shed light on areas of patients’ lives that were rarely captured — sexual health, skin disorders, gastrointestinal issues, and more.

And beyond treatment-related effects, mental health is increasingly recognized as an integral part of patient care. Depression in cancer patients, for example, has long been underreported in clinical trials. ePROs can bring them to light

‍

Can ePROs also help identify new toxicities?

Absolutely. I believe digital tools will allow us to capture parameters that were previously invisible — or that couldn’t be clearly linked to specific treatments.

Take antibody-drug conjugates as an example. They are associated with unusual patterns of pneumonitis, ocular toxicities, and dysgeusia. These effects were likely underestimated, or poorly categorized, within traditional toxicity frameworks. ePROs, by collecting continuous patient data, will allow us to better describe and understand them.

Consider a patient on an antibody-drug conjugate who develops pneumonitis: it’s likely that they experienced other subtle symptoms in the weeks beforehand.

With ePROs, those early warning signs can be detected. Real-world monitoring of this kind is essential. To ignore the potential of ePROs in clinical trials — where patient care should be at its highest standard — would be a serious missed opportunity. Beyond that, ePROs can generate valuable data to inform and accelerate drug development.

‍

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

We’re in 2024, and these tools are already available — alongside other digital applications that help us follow patients outside the hospital. Embedding them from the earliest phases of drug development is essential.

They give us the ability to design smarter treatment regimens, integrating data not only on adverse events, but also on patients’ daily lives and physical activity — factors that matter greatly. Bringing these insights into drug development from the very beginning will, in my view, be one of the key challenges in the years ahead.

‍

Sources

1. Janse van Rensburg HJ, Liu Z, Watson GA, Veitch ZW, Shepshelovich D, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. A tailored phase I-specificpatient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events. Br J Cancer. 2023 Sep;129(4):612-619. doi: 10.1038/s41416-023-02307-w.Epub 2023 Jul 7. PMID: 37419999; PMCID:PMC10421959.

‍

2. Veitch ZW, Shepshelovich D, Gallagher C, Wang L, Abdul Razak AR, Spreafico A, Bedard PL,Siu LL, Minasian L, Hansen AR. Underreporting of Symptomatic Adverse Events inPhase I Clinical Trials. J Natl Cancer Inst. 2021 Aug 2;113(8):980-988. doi:10.1093/jnci/djab015. PMID: 33616650; PMCID:PMC8502480.

‍

3. Watson GA, Veitch ZW, Shepshelovich D, Liu ZA, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE. Br J Cancer. 2022Nov;127(9):1629-1635. doi: 10.1038/s41416-022-01926-z. Epub 2022 Aug 25. PMID:36008705; PMCID: PMC9596492.

‍

4. Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, IvyP, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change -MDICT Guidelines 2022. Ann Oncol. 2023 Jan;34(1):48-60. doi:10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29. PMID: 36182023.

‍

5. Postel-Vinay S,Collette L, Paoletti X, Rizzo E, Massard C, Olmos D, Fowst C, Levy B, Mancini P, Lacombe D, Ivy P, Seymour L, Le Tourneau C, Siu LL, Kaye SB, Verweij J,Soria JC. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment RecommendationGroup for Early Trials of Targeted therapies, an European Organisation forResearch and Treatment of Cancer-led study. Eur J Cancer. 2014 Aug; 50(12):2040-9. doi: 10.1016/j.ejca.2014.04.031. Epub 2014 May 28. PMID:24880774.

‍

6. Postel-Vinay S. Redefining dose-limiting toxicity. Clin Adv Hematol Oncol. 2015 Feb;13(2):87-9. PMID:25774476.

‍

7. Cassel JB, Del Fabbro E, Arkenau T, Higginson IJ, Hurst S, Jansen LA, Poklepovic A, Rid A, Rodón J, StrasserF, Miller FG. Phase I Cancer Trials and Palliative Care: Antagonism,Irrelevance, or Synergy? JPain Symptom Manage. 2016 Sep;52(3):437-45. doi:10.1016/j.jpainsymman.2016.02.014. Epub 2016 May 24. PMID: 27233136.

‍

Heading

ePRO tools in early-phase trials: implications and outlook

Managing long-term toxicities, defining dose-limiting toxicities (DLTs), detecting adverse events: how can ePRO tools reshape early-phase trials?

Dec 3, 2025

5 minutes

For years, early-phase clinical trials focused almost exclusively on short-term dose-limiting toxicities (DLTs). That is starting to change. Today, researchers are adopting a broader, more continuous approach to monitoring treatment-related toxicities.

This is where electronic patient-reported outcomes (ePROs) come in. By capturing real‑time patient feedback on treatment tolerance, ePROs can uncover signs and symptoms that might otherwise go unnoticed¹–³ — and even help refine how DLTs are defined. Ultimately, these insights could reshape a more comprehensive approach to patient care.

We interviewed Prof. Christophe Massard, medical oncologist, Head of the Department of Therapeutic Innovation and Early Trials (DITEP) at Gustave Roussy, and Professor at Université Paris-Saclay, who shared his perspective during our conference “Digital Innovation in Oncology Clinical Research.” We are grateful to him for taking the time to share his reflections on this important topic.

‍

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

Until recently, phase I and II trials were focusing on DLTs observed in the first days or weeks of treatment. But over the past decade, mindsets have shifted. There’s now real awareness of the need to track toxicity over the long term.

A big part of this is due to targeted therapies, which have transformed outcomes for many patients. These drugs often cause few early DLTs but significant delayed toxicities. Immunotherapies have further changed the picture: their toxicities can surface weeks or even months after initiation. Several studies show that over half of severe toxicities now occur after the first cycle.

On top of that, the FDA has recently called for the integration of the Optimus Design in phase I trials, pushing for dose optimization earlier in development — without waiting for phase II or III. As a result, most current phase I studies now explore multiple dosing levels in light of varying toxicity profiles.

Phase I trials are no longer just about identifying the maximum tolerated dose. Increasingly — especially through cohort expansions — the goal is to define the optimal* dose. This is where PRO data can play a decisive role: by capturing patient-reported toxicities, they can inform dose recommendations for phase II and III, and ultimately help prevent late-stage trial failures caused by poor dose selection.

‍

*Optimal: great balance between efficacy and toxicity, increased focus on tolerability

‍

What value do ePROs add in early-phase trials?

Bringing ePROs in phase I and II trials has three clear benefits:

1. Sharper dose definition. They can help fine-tune what counts as a DLT and inform the recommended dose.

2. Better detection of undetected and underestimated side effects. Publications have shown that clinicians often underestimate certain adverse events, particularly gastrointestinal, cognitive, or sexual adverse events. ePROs capture symptomatic toxicities directly from patients, surfacing issues that might otherwise only emerge and be noticed in later phases, or even post-approval in real-world use¹–³.

3. Continuous monitoring. In early-phase trial, patients are typically seen weekly, biweekly, or monthly, and often do not report all side effects between two visits. ePROs allow near real-time capture of weak signals that may herald more serious toxicities — enabling earlier intervention

‍

How does the use of ePROs reflect a broader shift in trial design?

Traditionally, phases I, II, and III were seen as separate silos. Now, with Optimus Design, the goal is a continuum: optimization is pursued throughout drug development —ensuring that the dose administered in phase III and real-world settings is truly the most appropriate.

Trial designs have long been anchored in the framework of traditional chemotherapy. But with the advent of next-generation agents — especially antibody-drug conjugates — distinct patterns of toxicity are coming to light. I strongly believe that ePROs will be key to capturing these signals and defining the optimal dosing of such therapies.

To use a metaphor: not leveraging ePROs is like driving a Formula 1 car on a country road. Today’s therapies are our Formula 1 cars; to harness their full potential, we need the right “track”—tools that can precisely capture, characterize, and track patient-reported toxicities

So the real value of PROs and ePROs lies in their ability to optimize dosing?

Exactly. The objective isn’t to push for the highest tolerable dose, but to identify the optimal dose depending on the drug and its mechanism of action. We now recognize the need for different treatment regimens⁴,⁵ — including intermittent schedules with high doses given over just a few days. ePROs will be crucial in modeling and validating these approaches.

‍

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Traditionally, phase I studies focused on the first month — or at most the first two months — of treatment. But over the past decade, we’ve learned that grade I and II adverse events, while not severe individually, accumulate over time and significantly impact patients⁶,⁷. ePROs give us a more complete picture of these cumulative toxicities.

They also shed light on areas of patients’ lives that were rarely captured — sexual health, skin disorders, gastrointestinal issues, and more.

And beyond treatment-related effects, mental health is increasingly recognized as an integral part of patient care. Depression in cancer patients, for example, has long been underreported in clinical trials. ePROs can bring them to light

‍

Can ePROs also help identify new toxicities?

Absolutely. I believe digital tools will allow us to capture parameters that were previously invisible — or that couldn’t be clearly linked to specific treatments.

Take antibody-drug conjugates as an example. They are associated with unusual patterns of pneumonitis, ocular toxicities, and dysgeusia. These effects were likely underestimated, or poorly categorized, within traditional toxicity frameworks. ePROs, by collecting continuous patient data, will allow us to better describe and understand them.

Consider a patient on an antibody-drug conjugate who develops pneumonitis: it’s likely that they experienced other subtle symptoms in the weeks beforehand.

With ePROs, those early warning signs can be detected. Real-world monitoring of this kind is essential. To ignore the potential of ePROs in clinical trials — where patient care should be at its highest standard — would be a serious missed opportunity. Beyond that, ePROs can generate valuable data to inform and accelerate drug development.

‍

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

We’re in 2024, and these tools are already available — alongside other digital applications that help us follow patients outside the hospital. Embedding them from the earliest phases of drug development is essential.

They give us the ability to design smarter treatment regimens, integrating data not only on adverse events, but also on patients’ daily lives and physical activity — factors that matter greatly. Bringing these insights into drug development from the very beginning will, in my view, be one of the key challenges in the years ahead.

‍

Sources

1. Janse van Rensburg HJ, Liu Z, Watson GA, Veitch ZW, Shepshelovich D, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. A tailored phase I-specificpatient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events. Br J Cancer. 2023 Sep;129(4):612-619. doi: 10.1038/s41416-023-02307-w.Epub 2023 Jul 7. PMID: 37419999; PMCID:PMC10421959.

‍

2. Veitch ZW, Shepshelovich D, Gallagher C, Wang L, Abdul Razak AR, Spreafico A, Bedard PL,Siu LL, Minasian L, Hansen AR. Underreporting of Symptomatic Adverse Events inPhase I Clinical Trials. J Natl Cancer Inst. 2021 Aug 2;113(8):980-988. doi:10.1093/jnci/djab015. PMID: 33616650; PMCID:PMC8502480.

‍

3. Watson GA, Veitch ZW, Shepshelovich D, Liu ZA, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE. Br J Cancer. 2022Nov;127(9):1629-1635. doi: 10.1038/s41416-022-01926-z. Epub 2022 Aug 25. PMID:36008705; PMCID: PMC9596492.

‍

4. Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, IvyP, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change -MDICT Guidelines 2022. Ann Oncol. 2023 Jan;34(1):48-60. doi:10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29. PMID: 36182023.

‍

5. Postel-Vinay S,Collette L, Paoletti X, Rizzo E, Massard C, Olmos D, Fowst C, Levy B, Mancini P, Lacombe D, Ivy P, Seymour L, Le Tourneau C, Siu LL, Kaye SB, Verweij J,Soria JC. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment RecommendationGroup for Early Trials of Targeted therapies, an European Organisation forResearch and Treatment of Cancer-led study. Eur J Cancer. 2014 Aug; 50(12):2040-9. doi: 10.1016/j.ejca.2014.04.031. Epub 2014 May 28. PMID:24880774.

‍

6. Postel-Vinay S. Redefining dose-limiting toxicity. Clin Adv Hematol Oncol. 2015 Feb;13(2):87-9. PMID:25774476.

‍

7. Cassel JB, Del Fabbro E, Arkenau T, Higginson IJ, Hurst S, Jansen LA, Poklepovic A, Rid A, Rodón J, StrasserF, Miller FG. Phase I Cancer Trials and Palliative Care: Antagonism,Irrelevance, or Synergy? JPain Symptom Manage. 2016 Sep;52(3):437-45. doi:10.1016/j.jpainsymman.2016.02.014. Epub 2016 May 24. PMID: 27233136.

‍

ePRO tools in early-phase trials: implications and outlook

Managing long-term toxicities, defining dose-limiting toxicities (DLTs), detecting adverse events: how can ePRO tools reshape early-phase trials?

Dec 3, 2025

5 minutes

For years, early-phase clinical trials focused almost exclusively on short-term dose-limiting toxicities (DLTs). That is starting to change. Today, researchers are adopting a broader, more continuous approach to monitoring treatment-related toxicities.

This is where electronic patient-reported outcomes (ePROs) come in. By capturing real‑time patient feedback on treatment tolerance, ePROs can uncover signs and symptoms that might otherwise go unnoticed¹–³ — and even help refine how DLTs are defined. Ultimately, these insights could reshape a more comprehensive approach to patient care.

We interviewed Prof. Christophe Massard, medical oncologist, Head of the Department of Therapeutic Innovation and Early Trials (DITEP) at Gustave Roussy, and Professor at Université Paris-Saclay, who shared his perspective during our conference “Digital Innovation in Oncology Clinical Research.” We are grateful to him for taking the time to share his reflections on this important topic.

‍

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

Until recently, phase I and II trials were focusing on DLTs observed in the first days or weeks of treatment. But over the past decade, mindsets have shifted. There’s now real awareness of the need to track toxicity over the long term.

A big part of this is due to targeted therapies, which have transformed outcomes for many patients. These drugs often cause few early DLTs but significant delayed toxicities. Immunotherapies have further changed the picture: their toxicities can surface weeks or even months after initiation. Several studies show that over half of severe toxicities now occur after the first cycle.

On top of that, the FDA has recently called for the integration of the Optimus Design in phase I trials, pushing for dose optimization earlier in development — without waiting for phase II or III. As a result, most current phase I studies now explore multiple dosing levels in light of varying toxicity profiles.

Phase I trials are no longer just about identifying the maximum tolerated dose. Increasingly — especially through cohort expansions — the goal is to define the optimal* dose. This is where PRO data can play a decisive role: by capturing patient-reported toxicities, they can inform dose recommendations for phase II and III, and ultimately help prevent late-stage trial failures caused by poor dose selection.

‍

*Optimal: great balance between efficacy and toxicity, increased focus on tolerability

‍

What value do ePROs add in early-phase trials?

Bringing ePROs in phase I and II trials has three clear benefits:

1. Sharper dose definition. They can help fine-tune what counts as a DLT and inform the recommended dose.

2. Better detection of undetected and underestimated side effects. Publications have shown that clinicians often underestimate certain adverse events, particularly gastrointestinal, cognitive, or sexual adverse events. ePROs capture symptomatic toxicities directly from patients, surfacing issues that might otherwise only emerge and be noticed in later phases, or even post-approval in real-world use¹–³.

3. Continuous monitoring. In early-phase trial, patients are typically seen weekly, biweekly, or monthly, and often do not report all side effects between two visits. ePROs allow near real-time capture of weak signals that may herald more serious toxicities — enabling earlier intervention

‍

How does the use of ePROs reflect a broader shift in trial design?

Traditionally, phases I, II, and III were seen as separate silos. Now, with Optimus Design, the goal is a continuum: optimization is pursued throughout drug development —ensuring that the dose administered in phase III and real-world settings is truly the most appropriate.

Trial designs have long been anchored in the framework of traditional chemotherapy. But with the advent of next-generation agents — especially antibody-drug conjugates — distinct patterns of toxicity are coming to light. I strongly believe that ePROs will be key to capturing these signals and defining the optimal dosing of such therapies.

To use a metaphor: not leveraging ePROs is like driving a Formula 1 car on a country road. Today’s therapies are our Formula 1 cars; to harness their full potential, we need the right “track”—tools that can precisely capture, characterize, and track patient-reported toxicities

So the real value of PROs and ePROs lies in their ability to optimize dosing?

Exactly. The objective isn’t to push for the highest tolerable dose, but to identify the optimal dose depending on the drug and its mechanism of action. We now recognize the need for different treatment regimens⁴,⁵ — including intermittent schedules with high doses given over just a few days. ePROs will be crucial in modeling and validating these approaches.

‍

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Traditionally, phase I studies focused on the first month — or at most the first two months — of treatment. But over the past decade, we’ve learned that grade I and II adverse events, while not severe individually, accumulate over time and significantly impact patients⁶,⁷. ePROs give us a more complete picture of these cumulative toxicities.

They also shed light on areas of patients’ lives that were rarely captured — sexual health, skin disorders, gastrointestinal issues, and more.

And beyond treatment-related effects, mental health is increasingly recognized as an integral part of patient care. Depression in cancer patients, for example, has long been underreported in clinical trials. ePROs can bring them to light

‍

Can ePROs also help identify new toxicities?

Absolutely. I believe digital tools will allow us to capture parameters that were previously invisible — or that couldn’t be clearly linked to specific treatments.

Take antibody-drug conjugates as an example. They are associated with unusual patterns of pneumonitis, ocular toxicities, and dysgeusia. These effects were likely underestimated, or poorly categorized, within traditional toxicity frameworks. ePROs, by collecting continuous patient data, will allow us to better describe and understand them.

Consider a patient on an antibody-drug conjugate who develops pneumonitis: it’s likely that they experienced other subtle symptoms in the weeks beforehand.

With ePROs, those early warning signs can be detected. Real-world monitoring of this kind is essential. To ignore the potential of ePROs in clinical trials — where patient care should be at its highest standard — would be a serious missed opportunity. Beyond that, ePROs can generate valuable data to inform and accelerate drug development.

‍

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

We’re in 2024, and these tools are already available — alongside other digital applications that help us follow patients outside the hospital. Embedding them from the earliest phases of drug development is essential.

They give us the ability to design smarter treatment regimens, integrating data not only on adverse events, but also on patients’ daily lives and physical activity — factors that matter greatly. Bringing these insights into drug development from the very beginning will, in my view, be one of the key challenges in the years ahead.

‍

Sources

1. Janse van Rensburg HJ, Liu Z, Watson GA, Veitch ZW, Shepshelovich D, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. A tailored phase I-specificpatient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events. Br J Cancer. 2023 Sep;129(4):612-619. doi: 10.1038/s41416-023-02307-w.Epub 2023 Jul 7. PMID: 37419999; PMCID:PMC10421959.

‍

2. Veitch ZW, Shepshelovich D, Gallagher C, Wang L, Abdul Razak AR, Spreafico A, Bedard PL,Siu LL, Minasian L, Hansen AR. Underreporting of Symptomatic Adverse Events inPhase I Clinical Trials. J Natl Cancer Inst. 2021 Aug 2;113(8):980-988. doi:10.1093/jnci/djab015. PMID: 33616650; PMCID:PMC8502480.

‍

3. Watson GA, Veitch ZW, Shepshelovich D, Liu ZA, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE. Br J Cancer. 2022Nov;127(9):1629-1635. doi: 10.1038/s41416-022-01926-z. Epub 2022 Aug 25. PMID:36008705; PMCID: PMC9596492.

‍

4. Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, IvyP, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change -MDICT Guidelines 2022. Ann Oncol. 2023 Jan;34(1):48-60. doi:10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29. PMID: 36182023.

‍

5. Postel-Vinay S,Collette L, Paoletti X, Rizzo E, Massard C, Olmos D, Fowst C, Levy B, Mancini P, Lacombe D, Ivy P, Seymour L, Le Tourneau C, Siu LL, Kaye SB, Verweij J,Soria JC. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment RecommendationGroup for Early Trials of Targeted therapies, an European Organisation forResearch and Treatment of Cancer-led study. Eur J Cancer. 2014 Aug; 50(12):2040-9. doi: 10.1016/j.ejca.2014.04.031. Epub 2014 May 28. PMID:24880774.

‍

6. Postel-Vinay S. Redefining dose-limiting toxicity. Clin Adv Hematol Oncol. 2015 Feb;13(2):87-9. PMID:25774476.

‍

7. Cassel JB, Del Fabbro E, Arkenau T, Higginson IJ, Hurst S, Jansen LA, Poklepovic A, Rid A, Rodón J, StrasserF, Miller FG. Phase I Cancer Trials and Palliative Care: Antagonism,Irrelevance, or Synergy? JPain Symptom Manage. 2016 Sep;52(3):437-45. doi:10.1016/j.jpainsymman.2016.02.014. Epub 2016 May 24. PMID: 27233136.

‍

ePRO tools in early-phase trials: implications and outlook

Managing long-term toxicities, defining dose-limiting toxicities (DLTs), detecting adverse events: how can ePRO tools reshape early-phase trials?

Dec 3, 2025

5 minutes

For years, early-phase clinical trials focused almost exclusively on short-term dose-limiting toxicities (DLTs). That is starting to change. Today, researchers are adopting a broader, more continuous approach to monitoring treatment-related toxicities.

This is where electronic patient-reported outcomes (ePROs) come in. By capturing real‑time patient feedback on treatment tolerance, ePROs can uncover signs and symptoms that might otherwise go unnoticed¹–³ — and even help refine how DLTs are defined. Ultimately, these insights could reshape a more comprehensive approach to patient care.

We interviewed Prof. Christophe Massard, medical oncologist, Head of the Department of Therapeutic Innovation and Early Trials (DITEP) at Gustave Roussy, and Professor at Université Paris-Saclay, who shared his perspective during our conference “Digital Innovation in Oncology Clinical Research.” We are grateful to him for taking the time to share his reflections on this important topic.

‍

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

Until recently, phase I and II trials were focusing on DLTs observed in the first days or weeks of treatment. But over the past decade, mindsets have shifted. There’s now real awareness of the need to track toxicity over the long term.

A big part of this is due to targeted therapies, which have transformed outcomes for many patients. These drugs often cause few early DLTs but significant delayed toxicities. Immunotherapies have further changed the picture: their toxicities can surface weeks or even months after initiation. Several studies show that over half of severe toxicities now occur after the first cycle.

On top of that, the FDA has recently called for the integration of the Optimus Design in phase I trials, pushing for dose optimization earlier in development — without waiting for phase II or III. As a result, most current phase I studies now explore multiple dosing levels in light of varying toxicity profiles.

Phase I trials are no longer just about identifying the maximum tolerated dose. Increasingly — especially through cohort expansions — the goal is to define the optimal* dose. This is where PRO data can play a decisive role: by capturing patient-reported toxicities, they can inform dose recommendations for phase II and III, and ultimately help prevent late-stage trial failures caused by poor dose selection.

‍

*Optimal: great balance between efficacy and toxicity, increased focus on tolerability

‍

What value do ePROs add in early-phase trials?

Bringing ePROs in phase I and II trials has three clear benefits:

1. Sharper dose definition. They can help fine-tune what counts as a DLT and inform the recommended dose.

2. Better detection of undetected and underestimated side effects. Publications have shown that clinicians often underestimate certain adverse events, particularly gastrointestinal, cognitive, or sexual adverse events. ePROs capture symptomatic toxicities directly from patients, surfacing issues that might otherwise only emerge and be noticed in later phases, or even post-approval in real-world use¹–³.

3. Continuous monitoring. In early-phase trial, patients are typically seen weekly, biweekly, or monthly, and often do not report all side effects between two visits. ePROs allow near real-time capture of weak signals that may herald more serious toxicities — enabling earlier intervention

‍

How does the use of ePROs reflect a broader shift in trial design?

Traditionally, phases I, II, and III were seen as separate silos. Now, with Optimus Design, the goal is a continuum: optimization is pursued throughout drug development —ensuring that the dose administered in phase III and real-world settings is truly the most appropriate.

Trial designs have long been anchored in the framework of traditional chemotherapy. But with the advent of next-generation agents — especially antibody-drug conjugates — distinct patterns of toxicity are coming to light. I strongly believe that ePROs will be key to capturing these signals and defining the optimal dosing of such therapies.

To use a metaphor: not leveraging ePROs is like driving a Formula 1 car on a country road. Today’s therapies are our Formula 1 cars; to harness their full potential, we need the right “track”—tools that can precisely capture, characterize, and track patient-reported toxicities

So the real value of PROs and ePROs lies in their ability to optimize dosing?

Exactly. The objective isn’t to push for the highest tolerable dose, but to identify the optimal dose depending on the drug and its mechanism of action. We now recognize the need for different treatment regimens⁴,⁵ — including intermittent schedules with high doses given over just a few days. ePROs will be crucial in modeling and validating these approaches.

‍

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Traditionally, phase I studies focused on the first month — or at most the first two months — of treatment. But over the past decade, we’ve learned that grade I and II adverse events, while not severe individually, accumulate over time and significantly impact patients⁶,⁷. ePROs give us a more complete picture of these cumulative toxicities.

They also shed light on areas of patients’ lives that were rarely captured — sexual health, skin disorders, gastrointestinal issues, and more.

And beyond treatment-related effects, mental health is increasingly recognized as an integral part of patient care. Depression in cancer patients, for example, has long been underreported in clinical trials. ePROs can bring them to light

‍

Can ePROs also help identify new toxicities?

Absolutely. I believe digital tools will allow us to capture parameters that were previously invisible — or that couldn’t be clearly linked to specific treatments.

Take antibody-drug conjugates as an example. They are associated with unusual patterns of pneumonitis, ocular toxicities, and dysgeusia. These effects were likely underestimated, or poorly categorized, within traditional toxicity frameworks. ePROs, by collecting continuous patient data, will allow us to better describe and understand them.

Consider a patient on an antibody-drug conjugate who develops pneumonitis: it’s likely that they experienced other subtle symptoms in the weeks beforehand.

With ePROs, those early warning signs can be detected. Real-world monitoring of this kind is essential. To ignore the potential of ePROs in clinical trials — where patient care should be at its highest standard — would be a serious missed opportunity. Beyond that, ePROs can generate valuable data to inform and accelerate drug development.

‍

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

We’re in 2024, and these tools are already available — alongside other digital applications that help us follow patients outside the hospital. Embedding them from the earliest phases of drug development is essential.

They give us the ability to design smarter treatment regimens, integrating data not only on adverse events, but also on patients’ daily lives and physical activity — factors that matter greatly. Bringing these insights into drug development from the very beginning will, in my view, be one of the key challenges in the years ahead.

‍

Sources

1. Janse van Rensburg HJ, Liu Z, Watson GA, Veitch ZW, Shepshelovich D, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. A tailored phase I-specificpatient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events. Br J Cancer. 2023 Sep;129(4):612-619. doi: 10.1038/s41416-023-02307-w.Epub 2023 Jul 7. PMID: 37419999; PMCID:PMC10421959.

‍

2. Veitch ZW, Shepshelovich D, Gallagher C, Wang L, Abdul Razak AR, Spreafico A, Bedard PL,Siu LL, Minasian L, Hansen AR. Underreporting of Symptomatic Adverse Events inPhase I Clinical Trials. J Natl Cancer Inst. 2021 Aug 2;113(8):980-988. doi:10.1093/jnci/djab015. PMID: 33616650; PMCID:PMC8502480.

‍

3. Watson GA, Veitch ZW, Shepshelovich D, Liu ZA, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE. Br J Cancer. 2022Nov;127(9):1629-1635. doi: 10.1038/s41416-022-01926-z. Epub 2022 Aug 25. PMID:36008705; PMCID: PMC9596492.

‍

4. Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, IvyP, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change -MDICT Guidelines 2022. Ann Oncol. 2023 Jan;34(1):48-60. doi:10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29. PMID: 36182023.

‍

5. Postel-Vinay S,Collette L, Paoletti X, Rizzo E, Massard C, Olmos D, Fowst C, Levy B, Mancini P, Lacombe D, Ivy P, Seymour L, Le Tourneau C, Siu LL, Kaye SB, Verweij J,Soria JC. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment RecommendationGroup for Early Trials of Targeted therapies, an European Organisation forResearch and Treatment of Cancer-led study. Eur J Cancer. 2014 Aug; 50(12):2040-9. doi: 10.1016/j.ejca.2014.04.031. Epub 2014 May 28. PMID:24880774.

‍

6. Postel-Vinay S. Redefining dose-limiting toxicity. Clin Adv Hematol Oncol. 2015 Feb;13(2):87-9. PMID:25774476.

‍

7. Cassel JB, Del Fabbro E, Arkenau T, Higginson IJ, Hurst S, Jansen LA, Poklepovic A, Rid A, Rodón J, StrasserF, Miller FG. Phase I Cancer Trials and Palliative Care: Antagonism,Irrelevance, or Synergy? JPain Symptom Manage. 2016 Sep;52(3):437-45. doi:10.1016/j.jpainsymman.2016.02.014. Epub 2016 May 24. PMID: 27233136.

‍

ePRO tools in early-phase trials: implications and outlook

Managing long-term toxicities, defining dose-limiting toxicities (DLTs), detecting adverse events: how can ePRO tools reshape early-phase trials?

Dec 3, 2025

5 minutes

For years, early-phase clinical trials focused almost exclusively on short-term dose-limiting toxicities (DLTs). That is starting to change. Today, researchers are adopting a broader, more continuous approach to monitoring treatment-related toxicities.

This is where electronic patient-reported outcomes (ePROs) come in. By capturing real‑time patient feedback on treatment tolerance, ePROs can uncover signs and symptoms that might otherwise go unnoticed¹–³ — and even help refine how DLTs are defined. Ultimately, these insights could reshape a more comprehensive approach to patient care.

We interviewed Prof. Christophe Massard, medical oncologist, Head of the Department of Therapeutic Innovation and Early Trials (DITEP) at Gustave Roussy, and Professor at Université Paris-Saclay, who shared his perspective during our conference “Digital Innovation in Oncology Clinical Research.” We are grateful to him for taking the time to share his reflections on this important topic.

‍

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

Until recently, phase I and II trials were focusing on DLTs observed in the first days or weeks of treatment. But over the past decade, mindsets have shifted. There’s now real awareness of the need to track toxicity over the long term.

A big part of this is due to targeted therapies, which have transformed outcomes for many patients. These drugs often cause few early DLTs but significant delayed toxicities. Immunotherapies have further changed the picture: their toxicities can surface weeks or even months after initiation. Several studies show that over half of severe toxicities now occur after the first cycle.

On top of that, the FDA has recently called for the integration of the Optimus Design in phase I trials, pushing for dose optimization earlier in development — without waiting for phase II or III. As a result, most current phase I studies now explore multiple dosing levels in light of varying toxicity profiles.

Phase I trials are no longer just about identifying the maximum tolerated dose. Increasingly — especially through cohort expansions — the goal is to define the optimal* dose. This is where PRO data can play a decisive role: by capturing patient-reported toxicities, they can inform dose recommendations for phase II and III, and ultimately help prevent late-stage trial failures caused by poor dose selection.

‍

*Optimal: great balance between efficacy and toxicity, increased focus on tolerability

‍

What value do ePROs add in early-phase trials?

Bringing ePROs in phase I and II trials has three clear benefits:

1. Sharper dose definition. They can help fine-tune what counts as a DLT and inform the recommended dose.

2. Better detection of undetected and underestimated side effects. Publications have shown that clinicians often underestimate certain adverse events, particularly gastrointestinal, cognitive, or sexual adverse events. ePROs capture symptomatic toxicities directly from patients, surfacing issues that might otherwise only emerge and be noticed in later phases, or even post-approval in real-world use¹–³.

3. Continuous monitoring. In early-phase trial, patients are typically seen weekly, biweekly, or monthly, and often do not report all side effects between two visits. ePROs allow near real-time capture of weak signals that may herald more serious toxicities — enabling earlier intervention

‍

How does the use of ePROs reflect a broader shift in trial design?

Traditionally, phases I, II, and III were seen as separate silos. Now, with Optimus Design, the goal is a continuum: optimization is pursued throughout drug development —ensuring that the dose administered in phase III and real-world settings is truly the most appropriate.

Trial designs have long been anchored in the framework of traditional chemotherapy. But with the advent of next-generation agents — especially antibody-drug conjugates — distinct patterns of toxicity are coming to light. I strongly believe that ePROs will be key to capturing these signals and defining the optimal dosing of such therapies.

To use a metaphor: not leveraging ePROs is like driving a Formula 1 car on a country road. Today’s therapies are our Formula 1 cars; to harness their full potential, we need the right “track”—tools that can precisely capture, characterize, and track patient-reported toxicities

So the real value of PROs and ePROs lies in their ability to optimize dosing?

Exactly. The objective isn’t to push for the highest tolerable dose, but to identify the optimal dose depending on the drug and its mechanism of action. We now recognize the need for different treatment regimens⁴,⁵ — including intermittent schedules with high doses given over just a few days. ePROs will be crucial in modeling and validating these approaches.

‍

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Traditionally, phase I studies focused on the first month — or at most the first two months — of treatment. But over the past decade, we’ve learned that grade I and II adverse events, while not severe individually, accumulate over time and significantly impact patients⁶,⁷. ePROs give us a more complete picture of these cumulative toxicities.

They also shed light on areas of patients’ lives that were rarely captured — sexual health, skin disorders, gastrointestinal issues, and more.

And beyond treatment-related effects, mental health is increasingly recognized as an integral part of patient care. Depression in cancer patients, for example, has long been underreported in clinical trials. ePROs can bring them to light

‍

Can ePROs also help identify new toxicities?

Absolutely. I believe digital tools will allow us to capture parameters that were previously invisible — or that couldn’t be clearly linked to specific treatments.

Take antibody-drug conjugates as an example. They are associated with unusual patterns of pneumonitis, ocular toxicities, and dysgeusia. These effects were likely underestimated, or poorly categorized, within traditional toxicity frameworks. ePROs, by collecting continuous patient data, will allow us to better describe and understand them.

Consider a patient on an antibody-drug conjugate who develops pneumonitis: it’s likely that they experienced other subtle symptoms in the weeks beforehand.

With ePROs, those early warning signs can be detected. Real-world monitoring of this kind is essential. To ignore the potential of ePROs in clinical trials — where patient care should be at its highest standard — would be a serious missed opportunity. Beyond that, ePROs can generate valuable data to inform and accelerate drug development.

‍

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

We’re in 2024, and these tools are already available — alongside other digital applications that help us follow patients outside the hospital. Embedding them from the earliest phases of drug development is essential.

They give us the ability to design smarter treatment regimens, integrating data not only on adverse events, but also on patients’ daily lives and physical activity — factors that matter greatly. Bringing these insights into drug development from the very beginning will, in my view, be one of the key challenges in the years ahead.

‍

Sources

1. Janse van Rensburg HJ, Liu Z, Watson GA, Veitch ZW, Shepshelovich D, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. A tailored phase I-specificpatient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events. Br J Cancer. 2023 Sep;129(4):612-619. doi: 10.1038/s41416-023-02307-w.Epub 2023 Jul 7. PMID: 37419999; PMCID:PMC10421959.

‍

2. Veitch ZW, Shepshelovich D, Gallagher C, Wang L, Abdul Razak AR, Spreafico A, Bedard PL,Siu LL, Minasian L, Hansen AR. Underreporting of Symptomatic Adverse Events inPhase I Clinical Trials. J Natl Cancer Inst. 2021 Aug 2;113(8):980-988. doi:10.1093/jnci/djab015. PMID: 33616650; PMCID:PMC8502480.

‍

3. Watson GA, Veitch ZW, Shepshelovich D, Liu ZA, Spreafico A, Abdul Razak AR, Bedard PL, Siu LL, Minasian L, Hansen AR. Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE. Br J Cancer. 2022Nov;127(9):1629-1635. doi: 10.1038/s41416-022-01926-z. Epub 2022 Aug 25. PMID:36008705; PMCID: PMC9596492.

‍

4. Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, IvyP, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change -MDICT Guidelines 2022. Ann Oncol. 2023 Jan;34(1):48-60. doi:10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29. PMID: 36182023.

‍

5. Postel-Vinay S,Collette L, Paoletti X, Rizzo E, Massard C, Olmos D, Fowst C, Levy B, Mancini P, Lacombe D, Ivy P, Seymour L, Le Tourneau C, Siu LL, Kaye SB, Verweij J,Soria JC. Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment RecommendationGroup for Early Trials of Targeted therapies, an European Organisation forResearch and Treatment of Cancer-led study. Eur J Cancer. 2014 Aug; 50(12):2040-9. doi: 10.1016/j.ejca.2014.04.031. Epub 2014 May 28. PMID:24880774.

‍

6. Postel-Vinay S. Redefining dose-limiting toxicity. Clin Adv Hematol Oncol. 2015 Feb;13(2):87-9. PMID:25774476.

‍

7. Cassel JB, Del Fabbro E, Arkenau T, Higginson IJ, Hurst S, Jansen LA, Poklepovic A, Rid A, Rodón J, StrasserF, Miller FG. Phase I Cancer Trials and Palliative Care: Antagonism,Irrelevance, or Synergy? JPain Symptom Manage. 2016 Sep;52(3):437-45. doi:10.1016/j.jpainsymman.2016.02.014. Epub 2016 May 24. PMID: 27233136.

‍

Speakers:

Prof. Christophe Massard EN

Medical Oncologist — Head of the DITEP at Gustave Roussy — University Professor at Paris Saclay

Gustave Roussy

ePRO tools in early-phase trials: implications and outlook

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

What value do ePROs add in early-phase trials?

How does the use of ePROs reflect a broader shift in trial design?

So the real value of PROs and ePROs lies in their ability to optimize dosing?

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Can ePROs also help identify new toxicities?

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

Sources

Heading

ePRO tools in early-phase trials: implications and outlook

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

What value do ePROs add in early-phase trials?

How does the use of ePROs reflect a broader shift in trial design?

So the real value of PROs and ePROs lies in their ability to optimize dosing?

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Can ePROs also help identify new toxicities?

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

Sources

ePRO tools in early-phase trials: implications and outlook

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

What value do ePROs add in early-phase trials?

How does the use of ePROs reflect a broader shift in trial design?

So the real value of PROs and ePROs lies in their ability to optimize dosing?

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Can ePROs also help identify new toxicities?

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

Sources

ePRO tools in early-phase trials: implications and outlook

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

What value do ePROs add in early-phase trials?

How does the use of ePROs reflect a broader shift in trial design?

So the real value of PROs and ePROs lies in their ability to optimize dosing?

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Can ePROs also help identify new toxicities?

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

Sources

ePRO tools in early-phase trials: implications and outlook

Why are PROs and ePROs still rare in phase I/II trials—and what’s changing?

What value do ePROs add in early-phase trials?

How does the use of ePROs reflect a broader shift in trial design?

So the real value of PROs and ePROs lies in their ability to optimize dosing?

You mentioned the importance of tracking long-term toxicities. How can ePROs help here?

Can ePROs also help identify new toxicities?

Medical remote monitoring solutions, including ePRO platforms, enable continuous data collection from patients at home. Could we reach this level of understanding without them?

Sources

Speakers:

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