--- title: "How to Select and Adapt Oncology PROMs Under the 2024 FDA Guidance" description: "Dropout rates of 15-30% in AOM trials threaten regulatory submissions. Evidence-based strategies to improve participant retention in anti-obesity trials." type: article version: 1 version_id: "86ae513d-bf85-42fd-ae28-b1d00f29b98c" generated_at: "2026-06-22T10:53:11.793Z" author: "Signant Health" date_published: "2026-06-22T10:52:16.000Z" date_modified: "2026-06-22T10:52:16.330Z" language: en reading_time: "11 min" word_count: 2020 url: "https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance" --- # How to Select and Adapt Oncology PROMs Under the 2024 FDA Guidance > Dropout rates of 15-30% in AOM trials threaten regulatory submissions. Evidence-based strategies to improve participant retention in anti-obesity trials. ## Key Takeaways - Key Points: This whitepaper examines - AUTHOR BIO [Back to Resource Hub](https://signanthealth.com/resources) White paper # How to Select and Adapt Oncology PROMs Under the 2024 FDA Guidance [Signant Health](https://signanthealth.com/resources/author/signant-health) Jun 22, 2026 [ ](http://www.facebook.com/share.php?u=https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance&utm_medium=social&utm_source=facebook)[ ](http://www.linkedin.com/shareArticle?mini=true&url=https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance&utm_medium=social&utm_source=linkedin)[ ](https://twitter.com/intent/tweet?original_referer=https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance&utm_medium=social&utm_source=twitter&url=https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance&utm_medium=social&utm_source=twitter&source=tweetbutton&text=)[ ](mailto:?subject=Check%20out%20https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance&utm_medium=social&utm_source=email%20&body=Check%20out%20https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance&utm_medium=social&utm_source=email) [White paper](https://signanthealth.com/resources/tag/white-paper) Oncology PROM selection is now a regulatory design decision. The [FDA's final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/core-patient-reported-outcomes-cancer-clinical-trials) on core patient-reported outcomes in cancer clinical trials establishes five specific domains PROMs must measure independently. This white paper by Bill Byrom PhD and Anthony Everhart MD of Signant Health sets out what that means for instrument selection, assessment frequency, ePRO configuration, and instrument adaptation.   ## **Key Points: This whitepaper examines**    1. Why only three drug approvals out of 85 oncology medications submitted to the FDA between 2010 and 2016 included PROM-related labelling claims, and what design weaknesses in common PROM strategies the 2024 FDA final guidance directly addresses. 2. The FDA's five core measurement domains for oncology trials: disease-related symptoms, symptomatic adverse events, overall side effect impact, physical function, and role function, and why commonly used instruments may not deliver the domain-level specificity each requires. 3. Why assessment frequency must shift in early treatment cycles, with the FDA guidance recommending weekly measurement of symptomatic adverse events, overall side effect impact, and physical function from baseline, and how ePRO design choices, including multi-day completion windows and BYOD support participant adherence under treatment burden. 4. Three worked instrument examples assessing alignment with the FDA's core domain framework: the NSCLC-SAQ, the EORTC QLQ-C30 physical function subscale, and the FACT-B. Each is analyzed for where standard subscale structures map to FDA domains and where adaptation is required. 5. Two adaptation strategies for instruments that do not map cleanly to the five core domains: remapping existing validated items with scale author collaboration and drawing from pre-validated PROMIS and EORTC item banks to close domain coverage gaps. 6. The full white paper contains the complete FDA-recommended 12-month PROM assessment schedule, worked examples of subscale use and item bank application, and the authors' four trial design recommendations covering home-based ePRO, measurement selection, PROM development or adaptation, and missing data mitigation.  **Why the PROM Labelling Gap in Oncology Is a Patient Information Problem First**  For a person starting a new cancer treatment, the questions that matter most are not captured in a tumor response endpoint. Will this drug make me too tired to work? Will nausea be manageable? Will I be able to walk to my kitchen on day four of a cycle? Survival data and tumor shrinkage tell the prescribing physician whether the drug works. Only PROM data tells them what it is like to take it, and without that information in the labelling, the risk-benefit conversation with the patient is incomplete.  That gap is measurable. Of 85 oncology medications submitted to the FDA between 2010 and 2016, only three included PROM-related labelling claims ([Gnanasakthy et al., 2016; 2019](https://globalforum.diaglobal.org/issue/september-2021/commentary-the-impact-of-fdas-draft-guidance-for-oncology-patient-reported-outcomes-on-future-trial-design/)). The FDA's final guidance on core patient-reported outcomes in cancer clinical trials, published in 2024, addresses this directly. It identifies five core domains that oncology PROM strategies must measure and provides a recommended assessment schedule that increases measurement frequency in early cycles, when treatment-related side effects are most pronounced and current clinic-visit-only collection strategies systematically miss them. For oncology trials in design today, this guidance is not anticipatory. It is the current framework against which PROM strategies will be evaluated.   **What the Guidance Requires and Where Current Instruments Fall Short**  Sponsors and clinical teams developing oncology trials have often relied on established instruments, such as the EORTC QLQ-C30 or the FACT-B, on the reasonable basis that they are widely validated, translated into multiple languages, and accepted by regulators. That basis remains sound, but the 2024 FDA guidance introduces a specificity requirement that standard off-the-shelf subscale structures do not always satisfy.  The guidance requires PROMs to enable separate and independent measurement of each of the five core domains. A subscale that conflates role function with emotional well-being, or that groups disease-related symptoms with functional impact, does not meet that standard without adaptation.   Byrom and Everhart draw on Signant Health's oncology ePRO program and on published qualitative research examining participant burden during treatment cycles (Mowlem, Sanderson, Platko and Byrom, 2020, Journal of Comparative Effectiveness Research). Their approach to closing the domain coverage gap is structured around two adaptation pathways.  Sponsors designing or amending oncology PROM strategies for trials entering Phase 2 or Phase 3 will find the full white paper provides the complete assessment schedule, instrument analysis, and four actionable trial design recommendations to operationalize the FDA framework in their study.  > "The inclusion of PROM data on medication labelling provides valuable additional information for the prescribing physician to inform risk-benefit discussions with the patient beyond tumor response and survival endpoints. To achieve this, PROMs must enable the separate and independent assessment of each of the five core domains, with measures that are well-defined, reliable, and specific to the concept of interest." \- *Bill Byrom, PhD, Principal, eCOA Science, Signant Health; Anthony Everhart, MD, Clinical Vice President, Signant Health* > > * * * ## AUTHOR BIO  Name: Bill Byrom, Dan DeBonis, Anthony Everhart Title and Credentials: Bill Byrom, PhD, Principal, eCOA Science, Signant Health | Anthony Everhart, MD, Clinical Vice President, Internal Medicine, Signant Health Bio: Bill Byrom has worked in the pharmaceutical industry for more than 30 years and has authored over 70 publications and two industry textbooks on electronic patient-reported outcomes. His oncology ePRO work includes qualitative research into participant burden during treatment cycles, published in the Journal of Comparative Effectiveness Research (Mowlem, Sanderson, Platko and Byrom, 2020), and prior commentary on the FDA's oncology PRO guidance in DIA Global Forum (Byrom, Platko and Everhart, 2021).  Anthony Everhart is board-certified in Internal Medicine and a Fellow of the American College of Physicians, with over 25 years of medical practice experience and more than 14 years in clinical research. His clinical specialism at Signant Health spans decentralised trials, rater training, blinded data analytics, and patient-reported outcome strategy across oncology and internal medicine.  [DOWNLOAD THE WHITE PAPER](https://signanthealth.com/hubfs/Marketing%20Assets/White%20papers/White%20paper%20-%20Optimal%20COA%20Measurement%20Strategy%20in%20Modern%20Oncology%20Trials%20-%20Byrom%20Everhart.pdf) Designing your oncology PROM strategy for a Phase 2 or Phase 3 trial and need to map your instruments to the 2024 FDA core domain framework? [Speak to a Signant oncology eCOA expert.](/contact-sales)  ### Get notified on new marketing insights Here mention the benefits of subscribing --- ## About This Content **Source:** [How to Select and Adapt Oncology PROMs Under the 2024 FDA Guidance](https://signanthealth.com/resources/how-to-select-and-adapt-oncology-proms-under-the-2024-fda-guidance) **Author:** Signant Health **Published:** June 22, 2026 *This content is provided for informational purposes. Please visit the original source for the most up-to-date information.*