Regulatory spotlight
We offer selected excerpts from relevant guidances below, to help you get oriented and understand their significance. It is your responsibility to fully examine and interrogate these guidances in detail. Click through on individual resource links to be taken to the primary source material.
PRO guidance
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
PRO instruments must demonstrate content validity through patient input and qualitative research, ensuring the instrument measures concepts relevant to the population and condition being studied.
Sponsors must confirm the reliability, construct validity, and ability to detect change for the PRO instrument before use in confirmatory clinical trials.
Statistical analysis plans should address multiplicity, handling of missing data, and cumulative distribution function comparisons to interpret clinical trial results.
Modifications to PRO instruments (e.g., format changes, population adaptations) require evidence that measurement properties are preserved.
Electronic PRO systems must comply with regulatory requirements for data integrity, security, and investigator access.
Recommendations
Develop and validate PRO instruments early in the clinical development process, ensuring alignment with the clinical trial’s endpoint model.
Document all stages of instrument development, including qualitative input from patients, pilot testing, and cognitive interviews.
Use clear and consistent administration procedures, whether paper-based or electronic, to minimize variability and missing data.
Define responder thresholds using anchor-based methods and consider presenting cumulative distribution functions to interpret treatment benefits.
Address cultural and linguistic adaptation of PRO instruments by ensuring equivalent content validity and measurement properties across versions.
Regulatory Considerations
Include detailed descriptions of the PRO instrument, its conceptual framework, and scoring algorithms in regulatory submissions.
Ensure PRO instruments used in clinical trials comply with FDA requirements for record-keeping, data security, and source data accessibility.
Plan for the FDA to review all modifications to PRO instruments, including changes in administration mode or population.
Address missing data in clinical trial protocols and statistical analysis plans, ensuring prespecified handling rules.
Provide evidence that PRO instruments reliably measure the intended concepts across all study populations and data collection methods.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“A PRO is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. The outcome can be measured in absolute terms (e.g., severity of a symptom, sign, or state of a disease) or as a change from a previous measure. In clinical trials, a PRO instrument can be used to measure the effect of a medical intervention on one or more concepts (i.e., the thing being measured, such as a symptom or group of symptoms, effects on a particular function or group of functions, or a group of symptoms or functions shown to measure the severity of a health condition).
Generally, findings measured by a well-defined and reliable PRO instrument in appropriately designed investigations can be used to support a claim in medical product labeling if the claim is consistent with the instrument’s documented measurement capability. The amount and kind of evidence that should be provided to the FDA is the same as for any other labeling claim based on other data. Use of a PRO instrument is advised when measuring a concept best known by the patient or best measured from the patient perspective. A PRO instrument, like physician-based instruments, should be shown to measure the concept it is intended to measure, and the FDA will review the evidence that a particular PRO instrument measures the concept claimed. The concepts measured by PRO instruments that are most often used in support of labeling claims refer to a patient’s symptoms, signs, or an aspect of functioning directly related to disease status. PRO measures often represent the effect of disease.”
– Section II (Background), p. 2, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, Final, 2009 (FDA)
“The evaluation of a PRO instrument to support claims in medical product labeling includes the following considerations:
• The population enrolled in the clinical trial
• The clinical trial objectives and design
• The PRO instrument’s conceptual framework
• The PRO instrument’s measurement properties
Because the purpose of a PRO measure is to capture the patient’s experience, an instrument will not be a credible measure without evidence of its usefulness from the target population of patients. Sponsors should provide documented evidence of patient input during instrument development and of the instrument’s performance in the specific application in which it is used (i.e., population, condition). An existing instrument can support a labeling claim if it can be shown to reliably measure the claimed concept in the patient population enrolled in the clinical trial.”
– Section III (Evaluation of a PRO Instrument), p. 3, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, Final, 2009 (FDA)
PFDD 1: Comprehensive and representative input
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
Patient experience data encompass a range of inputs, including symptom burdens, treatment impacts, patient preferences, and views on unmet medical needs.
These data inform all stages of medical product development, from discovery to post-market use.
Quantitative methods (e.g., surveys) provide numerical insights, while qualitative methods (e.g., interviews) offer in-depth understanding. Mixed methods combine both for a fuller perspective.Social media and verified patient communities present novel data collection opportunities but require consideration of verification and representativeness challenges.
Probability sampling (e.g., stratified random sampling) is emphasized for generalizability, while non-probability methods (e.g., convenience sampling) are useful for exploratory research. Representativeness ensures that patient input reflects the diversity and heterogeneity of the target population.
Data collection should adhere to good clinical practices and regulatory standards.
Research protocols should address missing data, quality assurance, and confidentiality.
Early collaboration with the FDA is recommended to align on study designs and regulatory requirements.
Recommendations
Define clear research objectives and determine specific research questions before selecting data collection methods.
Use probability sampling methods whenever feasible to ensure representativeness of the target population.
Address data quality through rigorous planning, data management, and adherence to FDA-supported standards.
Incorporate diverse perspectives by including underrepresented patient populations, tailoring methods to specific subgroups as needed.
Leverage existing data sources, such as patient registries and literature, to complement primary data collection efforts.
Regulatory Considerations
Data submitted to FDA should include clear documentation of the study protocol, intended use, and data collection methodologies.
Researchers must comply with human subject protection regulations (e.g., 21 CFR Parts 50 and 56) and good clinical practice guidelines.
For data intended to support regulatory submissions, adherence to FDA-supported data standards (e.g., CDISC) is strongly encouraged.
Missing data should be addressed through pre-planned strategies and summarized in the study report.
Patient experience data must meet methodological rigor to ensure their reliability and relevance for regulatory decision-making.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“This guidance is intended to address both a statutory requirement under the 21st Century Cures Act of 2016 (hereafter referred to as “Cures Act”) Section 3002 (c) and a commitment made under the Prescription Drug User Fee Act (PDUFA) VI (authorized under the FDA Reauthorization Act of 2017 (FDARA), Title I) to issue methodological guidance to support patient-focused drug development.”
– Introduction, p. 1, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“The guidance to be issued under Cures Act section 3002(c)(1) shall address: “Methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decision making may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis.””
– Introduction, p. 1, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“FDA is publishing a series of guidances intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision-making.”
– Introduction, p. 2, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“This expansive definition of “patient experience data” includes a wide range of opportunities for the collection of information that might be used to inform and provide a greater patient focus in medical product development.”
– Introduction, p. 2, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“Patient experience data include the experiences, perspectives, needs, and priorities of patients related to: The signs and symptoms patients experience and how these signs and symptoms affect their day-to-day functioning and quality of life; The course of their disease over time, including the effect the disease has on patients’ day-to-day function and quality of life over time, and the changes that patients experience in their symptoms over time; Patients’ experience with the treatments for their disease: the symptoms and burdens related to treatment; Patients’ views on potential disease or treatment outcomes and how they weigh the importance of different possible outcomes; How patients view the impact of the disease, treatment, and outcomes, and their view of potential tradeoffs between disease outcomes and treatment benefits and risks.”
– Section I.B (Patient Experience Data), p. 4, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“The patient experience in a medical product development context incorporates their journey throughout the course of their disease or condition, including patient views, feelings, needs, actions, preferences, and interactions (e.g., clinical trials, home life, social life) with respect to their disease and its treatment.”
Section I.B (Patient Experience Data), p. 4, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“Patient experience data may be collected throughout medical product development, beginning at the launch of a discovery program, or may be independent of any specific medical product development program.”
– Section I.B (Patient Experience Data), p. 5, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“Patient-Focused Drug Development (PFDD) (also referred to as patient-focused medical product development): A systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into the development and evaluation of medical products throughout the medical product life cycle.”
– Appendix 2 (Glossary), p. 37, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
“Patient-Focused (also referred to as patient-centered): Ensuring that patients’ experiences, perspectives, needs, and priorities are meaningfully incorporated into decisions and activities related to their health and well-being.”
– Appendix 2 (Glossary), p. 37, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Final, 2020 (FDA)
PFDD 2: What is important to patients
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
Qualitative Methods: One-on-one interviews provide in-depth individual insights, while focus groups capture diverse perspectives through participant interaction.
Approaches such as Delphi panels and observational methods can complement interviews and focus groups in understanding patient experiences.
Quantitative Methods: Surveys provide structured, quantifiable data and are effective for large populations.
Careful design of questions and response options minimizes bias and improves data quality.
Mixed Methods:Combining qualitative and quantitative techniques enhances understanding and validates findings.
Sequential and concurrent designs can address complex research questions and improve robustness.
Barriers to Self-Report: Special adaptations may be needed for patients with disabilities, pediatric populations, or those with language or cultural differences.
Proxy reporting by caregivers is sometimes necessary but may introduce bias.
Social Media: Useful for real-time or retrospective insights into patient perspectives. Limitations include lack of verified identities and potential bias in user demographics.
Recommendations
Choose data collection methods aligned with research objectives and the target population.
Use open-ended questions for qualitative research to elicit unbiased responses; avoid leading or judgmental prompts.
Pilot test interview guides, surveys, and response options to ensure clarity and relevance.
Integrate cultural and linguistic adaptations for diverse populations in multinational studies.
For mixed-method research, establish clear objectives for combining qualitative and quantitative components and address conflicting findings systematically.
Regulatory Considerations
Data collected through qualitative or quantitative methods must meet regulatory standards for integrity and reliability when submitted to the FDA.
Screening and exit interviews should not interfere with the integrity of ongoing clinical trials; use trained third-party interviewers where appropriate.
Researchers should follow ethical standards and federal regulations when using social media data, ensuring informed consent and data privacy.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“The methods described in this document can be used to elicit what is important to patients, which may in turn help inform understanding of disease/condition and clinical trial design. It may also help the generation and use of patient experience data, including clinical outcome assessments and patient preference information, to inform benefit-risk assessment.”
– Section I (Purpose and Scope of Guidance 2), p. 2, Patient-Focused Drug Development: Methods to Identify What Is Important to Patients, Final, 2022 (FDA)
“FDA encourages stakeholders to interact early with FDA and obtain feedback from the relevant FDA review division when considering collection of patient experience data related to the burden of disease and treatment.”
– Section I (Introduction), p. 2, Patient-Focused Drug Development: Methods to Identify What Is Important to Patients, Final, 2022 (FDA)
“Research to understand what matters most to patients living with a disease or condition to guide medical product development should begin with a characterization of the disease or condition and currently available therapies. Before conducting studies in patients, which may involve their caregivers as well, literature reviews, consultation with relevant subject matter experts, and other information sources should be used to develop targeted research questions and select appropriate methods to identify what matters most to patients regarding their experience with their disease or condition.”
– Section II (Background Research), p. 3, Patient-Focused Drug Development: Methods to Identify What Is Important to Patients, Final, 2022 (FDA)
PFDD 3: Fit-for-purpose clinical outcome assessments (COAs)
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
The guidance applies to four types of Clinical Outcome Assessments (COAs): Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs), Clinician-Reported Outcomes (ClinROs), and Performance Outcomes (PerfOs). A COA is considered fit-for-purpose when the validation evidence is sufficient to support its context of use (COU). To determine if a COA is fit-for-purpose, sponsors must clearly describe the Concept of Interest (COI) and the COU, and present sufficient evidence to support a clear rationale for the COA’s proposed interpretation and use. The rationale for using a COA should include up to eight components, such as justification for the COA type, capturing the important parts of the COI, appropriate administration and scoring, minimal influence from irrelevant factors or measurement error, and correspondence with the Meaningful Aspect of Health (MAH). The most direct assessment of how a patient feels or functions (MAH) should be used as the COI whenever possible.
Recommendations
Sponsors should use the Roadmap to Patient-Focused Outcome Measurement to guide the selection, modification, or development of a COA. The process begins with understanding the disease/condition (including patient perspectives) and conceptualizing clinical benefits and risks (defining the MAH, COI, and COU). When feasible, existing COAs are generally preferred, especially for well-established COIs, as this approach is often the least burdensome. If an existing COA is modified or used in a different context, additional evidence (e.g., cognitive interviews, psychometric studies) must be collected to justify its fitness for the new context of use. For new COA development, sponsors should involve patients, document all steps, and generally avoid using the new COA for the first time in a registration (pivotal) trial; a standalone observational study or early phase trial is recommended for evaluation.
Regulatory Considerations
Sponsors are encouraged to interact early and throughout medical product development with the relevant FDA review division to ensure COAs are appropriate for the intended COU. Sponsors should communicate their proposed COA-based endpoint approach, including the MAH, COI, COA type/name/score, and the final COA-based endpoint, ideally using the suggested format. The type and amount of evidence required to support the rationale for a COA’s use is weighed against the degree of uncertainty regarding that part of the rationale. For ClinROs, it is recommended to use an assessor masked to treatment assignment and study visit for primary endpoints, if feasible. FDA strongly discourages proxy-reported measures for concepts known only to the patient (e.g., pain) and recommends using an ObsRO to measure observable behaviors instead when the patient cannot self-report.
Recommendations
Clearly define the concept of interest and its context of use to ensure COAs align with trial objectives.
Use conceptual and measurement frameworks to communicate how COAs measure patient experiences and generate interpretable scores.
Leverage existing COAs where possible, modifying them only when justified, and document all modifications rigorously.
Ensure COAs are accessible and inclusive, incorporating features like large fonts, touch interfaces, or audio assistance for diverse populations.
Conduct early engagement with FDA to discuss COA selection, development, and validation plans.
Regulatory Considerations
Fit-for-purpose validation requires evidence of conceptual alignment, scoring reliability, and sensitivity to clinically meaningful changes.
Digital health technologies used for COAs must comply with FDA’s guidance on data integrity, usability, and technical performance.
COAs intended for regulatory submissions must be developed and validated before pivotal trials to avoid jeopardizing trial outcomes.
Modifications to COAs or scoring methods during trials necessitate justification and revalidation.
Sponsors should submit comprehensive documentation on COA development, including scoring algorithms and item tracking matrices.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“This guidance is intended to help sponsors use high quality measures of patients’ health in medical product development programs. Ensuring high quality measurement is important for several reasons: measuring what matters to patients; being clear about what was measured; appropriately evaluating the effectiveness, tolerability, and safety of treatments; and avoiding misleading claims.”
– Section I.B (Purpose and Scope of the Guidance), p. 3, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, Final, 2025 (FDA)
“Patients and caregivers have been increasingly integrated as stakeholders in the development and evaluation of medical products.”
– Section I.A (Overview of FDA Guidances on Patient-Focused Drug Development), p. 4, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, Final, 2025 (FDA)
“In a clinical trial, it is important to carefully select concepts that, when measured adequately:
• Reflect an aspect of health that is important to patients
• Have the ability to be modified by the investigational treatment
• Could demonstrate clinically meaningful differences between study arms within the time frame of the planned clinical trial”
– Section II.B.1 (The Concept of Interest), p. 6, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, Final, 2025 (FDA)
“The first step involves considering the manifestations and natural history of the disease or condition; important patient subpopulations; the clinical environment in which patients with the condition seek care; and patient and/or caregiver perspectives on the disease, its impacts, and therapeutic needs and priorities. One important outcome of this step is understanding and summarizing the important signs, symptoms, and health impacts patients with the disease or condition might experience. The next step involves considering which aspect(s) of the patient’s experience with the disease/condition and/or its treatment will be targeted by the medical product.”
Section III.A.1–2 (Understanding the Disease or Condition; Conceptualizing Clinical Benefits and Risks), pp. 12–13, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, Final, 2025 (FDA)
“A conceptual model can be useful for representing patients’ specific health experiences that result from their disease/condition, the health concepts that describe those specific experiences, and the concept(s) of interest selected for assessment.”
– Section II.B.1 (The Concept of Interest), p. 8, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, Final, 2025 (FDA)
PFDD 4: Incorporating COAs into endpoints
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
COA-based endpoints should reflect meaningful patient health aspects and support clear treatment effect inferences.
Selection of endpoints requires a well-supported rationale, including evidence of their importance to patients.
Use of MSD and MSR approaches enhances the interpretation of treatment effects by linking COA scores to meaningful patient experiences. Proper anchors (e.g., global impression of severity) are essential for validating these approaches.
Frequency and timing of COA data collection must align with disease characteristics and study objectives.
Adjustments for potential practice effects and assistive device use are critical for robust outcome measurement.
Proper handling of missing data and sensitivity analyses ensure valid conclusions from COA-based endpoints.
Continuous, ordinal, and dichotomized endpoints require tailored statistical methods for analysis.
Early engagement with the FDA is crucial for aligning study designs and COA approaches with regulatory expectations.
Recommendations
Engage patients and caregivers early to identify meaningful endpoints and assess potential barriers to COA use.
Use anchor-based methods to validate COA scores and define meaningful thresholds for interpretation.
Develop and pilot test study protocols to ensure COA reliability, usability, and alignment with regulatory requirements.
Implement strategies to reduce participant burden, such as concise COA instruments and patient-friendly data collection methods.
Submit comprehensive documentation, including endpoint justification and scoring rationale, to FDA for feedback before trial initiation.
Regulatory Considerations
Endpoints must be supported by evidence of their fit-for-purpose status and alignment with the trial’s objectives.
COAs used in digital or adaptive formats must meet FDA’s standards for usability and data integrity.
Trials with nonrandomized designs require robust measures to mitigate bias in COA-based endpoint analysis.
Thresholds for MSD or MSR must be prespecified and justified with empirical evidence.
Sponsors must follow FDA guidance for submitting COA-based data, ensuring compliance with electronic data standards.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“FDA encourages stakeholders to interact early with FDA and obtain feedback from the relevant FDA review division when considering the collection of patient experience data related to the burden of disease and the benefits, burdens, and harms of treatment. FDA recommends that stakeholders engage with patients and other appropriate subject matter experts (e.g., clinical and disease experts, qualitative researchers, survey methodologists, statisticians, psychometricians, patient preference researchers) when designing and implementing studies to evaluate the burden of disease and treatment, and perspectives on treatment benefits and risks.”
– Section I.A (Overview of the PFDD guidance series), p. 2, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making, Draft, 2023 (FDA)
Clinical trials with decentralized elements
Conducting Clinical Trials With Decentralized Elements
Coordination challenges with multiple locations in DCTs.
Variability in data collection across decentralized locations and remote tools.
Challenges in implementing certain statistical approaches in DCTs.
Need for DHTs to be accessible and suitable for all trial participants.
Ensuring compliance with local laws and regulations.
Recommendations
Develop clear protocols for integrating decentralized elements into clinical trials, specifying remote and in-person activities.
Use digital health technologies (DHTs) and electronic systems to streamline data acquisition, informed consent, and investigational product tracking.
Provide training for all stakeholders, including trial personnel, local health care providers, and participants, on decentralized processes.
Implement robust safety monitoring plans to address adverse events in decentralized settings.
Ensure compliance with local and international laws governing telehealth, data privacy, and investigational product use.
Regulatory Considerations
Maintain compliance with FDA requirements under 21 CFR parts 312 and 812 for drug and device trials, respectively.
Document all trial activities and data flows in trial protocols and data management plans, ensuring traceability and integrity.
Ensure informed consent processes meet FDA standards and provide clear communication to participants about decentralized trial activities and data handling.
Address investigational product accountability by documenting IP distribution, storage, and return or disposal.
Design electronic systems for decentralized trials to comply with 21 CFR part 11 requirements for data reliability, security, and confidentiality.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“Digital health technologies (DHTs), for example, have expanded the types of trial-related data that can be obtained remotely from trial participants. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or limited access to traditional clinical trial sites. This may help improve trial participant engagement, recruitment, enrollment, and retention of a more representative trial participant population to improve the strength and generalizability of the evidence produced by the trial.”
– Section II (Background), p. 2, Conducting Clinical Trials With Decentralized Elements, Final, 2024 (FDA)
“In general, obtaining patient input may be helpful in ensuring that the clinical trial design fits participants’ needs and that remote activities are feasible.”
– Section III.A (DCT Design and Conduct), p. 4, Conducting Clinical Trials With Decentralized Elements, Final, 2024 (FDA)
“The clinical trial population should reflect the intended patient population for the medical product being studied, including with respect to race, ethnicity, age, sex, and geographic location, as applicable… Bringing trial-related activities to participants’ homes may reduce the need for travel and improve engagement, recruitment, and retention… The use of local HCPs close to potential participants’ homes may further improve engagement, recruitment, and retention of a more representative participant population and reduce cultural or linguistic barriers to participation in clinical trials.”
– Section III.D.1 (Roles and Responsibilities — The Sponsor), p. 7, Conducting Clinical Trials With Decentralized Elements, Final, 2024 (FDA)
Scope of PFDD guidances
The FDA’s Patient-Focused Drug Development (PFDD) Guidance Series “is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making.”
While the PFDD series provides this key framework, different FDA centers emphasize distinct guidances in their assessments. For instance, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) currently utilize PFDD 1 and 2. In contrast, the Center for Devices and Radiological Health (CDRH) uses Principles for Selecting, Developing, Modifying, and Adapting Patient Reported Outcome Instruments for Use in Medical Device Evaluation, for patient-reported outcomes. All centers are also preparing for the implementation of PFDD 3 (finalized Oct 2025) and the forthcoming PFDD 4, which will together replace the older 2009 guidance on Patient-Reported Outcome Measures.
Once you’ve read the guidances, explore these best practices from the field:
Industry spotlight
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