In recent years, the pharmaceutical industry, and its regulatory agencies – the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) – have come to realize and acknowledge the value that patient feedback brings to medical product development.
We had a talk with one of our Senior Research Associates, Janni Lisander Larsen, regarding her views and experiences on the pharmaceutical industry’s increasing focus on integrating patients in clinical trials as part of the drug development process.
Janni has worked in the field of chronic, rare, and autoimmune diseases, and holds over 15 years of experience in project management and qualitative research within patient experiences. Janni has had peer-reviewed articles published in medical journals, e.g., the British Medical Journal Open.
“I think the patients’ voices are needed on so many levels of the drug development process. Implementing patient interviews in clinical trials is a part of this necessity.” Janni Lisander Larsen, Sr. Research Associate at Clinigma
The patient-centric line of thought in the regulatory agencies is emphasized by the FDA’s Patient-Focused Drug Development (PFDD) guidance on how to collect patient feedback in clinical trials, and most importantly its demand for patient-experience data to be included in new drug applications from 2021. The EMA has also shown support to the patient-centric movement in its Regulatory Science Strategy to 2025.
“The main reason why integrating patients in the drug development process is valuable is that it helps in understanding the patients’ perspectives and experiences with the drug.” Janni Lisander Larsen, Sr. Research Associate at Clinigma
As a result of the FDA and EMA’s expectations and requirements, it is expected that other regulatory agencies and HTAs will also begin requesting more detailed patient-experience data – for instance when assessing whether or not a new drug addresses the needs of a specific patient group. It is imperative that pharmaceutical companies are prepared to meet the increased expectations for the collection of patient-experience data in clinical trials.
“Collecting qualitative data through patient interviews in clinical trials supports the exploration of a patients’ quality of life and the interpretation of clinical endpoints.” Janni Lisander Larsen, Sr. Research Associate at Clinigma
Conducting patient interviews in clinical trials allows pharmaceutical companies to gather insights directly from the medicine users and obtain valuable input into drug development. Moreover, the insights obtained from patient interviews can be used as additional arguments for the regulators’ approvals of a new drug.
“Pharmaceutical companies who choose to conduct patient interviews in clinical trials
Direct patient feedback is set to change how medical products are developed, used, and valued, and, in doing so, minimizes the uncertainties of drug development and approvals.
Would you like to learn about the consequences of not listening to the patients in clinical trials? Please click here.