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Patient-reported outcome (PRO) assessments have become valuable tools for incorporating patient voice in medical product development. PRO data can be collected throughout the full product life cycle, from early development to clinical trials and observational studies. PROs may be utilized as the basis for:
Regulatory agencies, such as the U.S. FDA and EMA, fit PROs into the broad category of “patient experience data (PED).” PED reflect patients’ experiences, perspectives, needs, and priorities throughout their patient journey. These agencies used their strategic initiatives and guidance documents to promote PED as a key contributing component in product development and regulatory decision-making.
However, a complete alignment between regulators and the industry on usage of PED is a work in progress. Despite the FDA’s strong advocacy for PED, it was reported that marketing authorization applicants, patients, and caregivers have insufficient clarity regarding how the agency uses such data in its decisions when reviewing applications for new drugs and biologics. Similarly, a multidisciplinary workshop led by the EMA revealed the industry stakeholders’ perception that the EU regulator doesn’t welcome PED or consider these data valuable.
These factors lead to industry stakeholders’ reluctance to include PED in support of marketing authorization applications. The EMA has since clarified that they “welcome and want” PED as part of marketing authorization applications.
To enable the generation of relevant, sufficient, and reliable PED, more transparency is required surrounding usage of such data in regulatory decision-making. Achieving this transparency requires a greater harmonization across jurisdictions of regulatory requirements for PED collected in multi-regional trials. As the European Federation of Pharmaceutical Industries and Associations (EFPIA) proposed, the ICH M4E presents the appropriate level for a global alignment on these requirements.
While essential to medical product development overall, regulatory uncertainties won’t likely be of immediate concern for trial participants. A more pressing issue is respondent burden, which application of PROs may give rise to. These various factors may contribute:
Anticipating and mitigating respondent burden is critical to overall success of PRO data collection strategy in a trial. Aiyegbusi and colleagues presented a succinct summary of key methodological considerations for addressing respondent burden. Among these are:
With the proliferation of multinational clinical trials and an increase in usage of ePRO technology, trial sponsors often have to modify original PROs. Modification may include translation and cross-cultural adaptation into other languages (linguistic validation) or migration from paper to the electronic mode of administration (ePRO migration). Testing modified versions with target patient populations may help identify and resolve issues before these versions are used in a trial. The benefits are manifold:
Specialist language service providers (LSPs) may facilitate such testing through cognitive debriefing and usability testing procedures. Testing is conducted in relevant target country(-ies) with a small group of native speakers of target language/s who adequately represent the clinical trial’s target population.
Copyright Permissions for Use of Clinical Outcome Assessments in Clinical Trials Blog
* with reference to ISPOR Task Force for Translation and Cultural Adaptation and Patient-Reported Outcome (PRO) Consortium
**with reference to ISPOR ePRO Good Research Practices Task Force and ISPOR Measurement Comparability Between Modes of Administration of PROMs Task Force
Need language assistance for your patient-reported outcome data collection in clinical trials? Lionbridge has deep knowledge of the clinical outcome assessment domain and expertise in life sciences translation services. Contact us today to learn more about Lionbridge as a life sciences language service provider.