Interviewing patients can help you in choosing the most relevant patient-reported outcome measures to apply in your clinical trials
Patient-reported outcome measures (PROMs) are frequently applied in clinical trials to reveal patients’ experiences of an investigational drug. Yet, it can be challenging to select a suitable set of PROMs to use in a clinical trial – especially in the early stages of a trial program when the product profile of the investigational drug may be uncertain.
PROMs applied in clinical trials typically consist of pre-defined closed-ended questions developed and validated in a given population based on existing therapies. However, using existing validated PROMs may be limited in providing the full picture of a novel treatment with novel attributes, and can be questioned in the following way:
- How do you know that the pre-specified questions asked are patient-relevant?
- How do you know that the patients’ experiences with the investigational drug do not go beyond the pre-specified questions asked?
- How do you know that the pre-specified questions allow the patients to express what matters the most to them?
To overcome these limitations, it can be beneficial to interview patients prior to selecting the PROMs. This can help you ensure the patient relevance of the measurements applied in the clinical trial and help you in getting a more complete picture of the patients’ experiences of the investigational drug. In addition, it allows patients to more freely express what they think about the investigational drug and what matters the most to them when using the new drug.
In this way, patient interviews can provide a strong basis for developing patient-relevant PROMs that better allow patients to share their experiences on the effects of the investigational drug and provide valuable insights that make it easier for you to interpret the PROM results. Moreover, it can provide you with answers to the FDA when they ask for evidence to support that what you have measured in your clinical trial is meaningful to the patients.
We would like to know more about your experiences working with PROMs in clinical trials
How do you experience working with PROMs in clinical trials?
Following the increasing attention from regulatory authorities on actively including trial patients’ voices in clinical trials, we are currently working on finalising a survey to examine how PROMs are applied in drug development.
Through this survey we will for example seek to get a better understanding of your experiences/challenges with selecting suitable PROMs and interpreting PROM results from clinical trials.
Next week we will share more information about the survey, and how you can sign up to receive the results.
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