Are you overlooking important patient feedback on your investigational drug?
Interestingly, the pharmaceutical industry is one of the few industries where direct user feedback is not an active part of the product development process – i.e. listening to the patients as part of the drug development process is not common practice. Consequently, pharmaceutical companies risk overlooking important patient feedback when developing new drugs.
Please take a minute to consider this:
- If you do not listen to the patients, how do you obtain sufficient knowledge on what the patients think about a new drug, how the drug impacts their daily lives, and what matters the most to them when using the drug?
- If you do not obtain direct patient feedback, how do you ensure a complete picture of the patients’ experiences of the investigational drug?
- If you do not talk with the patients, how do you ensure that what you measure in your clinical trials is relevant and meaningful to the patients?
In drug development, these topics are currently sought to be covered through the application of Patient-Reported Outcome Measures (PROMs) in clinical trials. Yet, PROMs typically consist of pre-specified closed-ended questions, which means that they do not allow for patients to freely share their experiences. Furthermore, PROMs address the concepts that are anticipated to be relevant and important to patients at the outset of a study, and thus unexpected, yet important, patient-perceived effects are often overlooked.
Despite the apparent negative consequences of not involving the patients to inform the drug development, there can still be a reluctance within pharmaceutical companies to embark on patient engagement. Most often they fear that the patients´ feedback may be contradicting to the trial results. However, this concern is misunderstood as the interviews are more to help inform the interpretation of the results than to replicate them.
Interviewing patients strengthens not only the patient engagement in your drug development but also helps ensure the patient relevance of the measurements applied in your clinical trials. In this way, it can provide you with answers when the FDA asks for evidence to support that what you have measured in your clinical trial is meaningful to the patients.
Click here to read more about patient interviews.