Get the full picture of a treatment
To ensure that you get a clearer picture of a treatment, we recommend interviewing the users who are exposed to a drug candidate as early as possible in the trial program. This type of feedback will raise the quality of your insights into the safety and efficacy of an investigational drug and can be used as additional arguments for regulators’ approval of the drug as well as input to the discussion and design of future trials.
Click here to learn about our expert solutions to capture trial patient feedback.
Regulatory authorities already consider patient-experience data in their product evaluations
Regulatory authorities – led by the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) – has issued a call for Patient-Focused Drug Development (PFDD) and has already initiated efforts to include patient-experience data in their decisions to approve new medicines. For example, FDA has developed PFDD guidances to strengthen the patient feedback in clinical trials and is expected in 2021 to start asking for patient-experience data to be included in new drug applications.
As a result of the increasing attention that is put on capturing patient feedback, it is expected that more regulatory authorities and HTAs will start to request more detailed patient-experience data going forward.
What are you doing to integrate the patient perspective into your drug development process?
Click here to get an overview of key milestones for the integration of patient perspectives into regulatory processes.
Do you want to know more about why you should interview patients in clinical trials?
Join our free webinar on October 8 to get a better understanding of the benefits of integrating patient interviews into your clinical trial protocols, and obtain valuable insights on regulatory trends and guidelines on patient-focused drug development from FDA and EMA.
If you haven’t signed up yet, sign up for our free webinar here.
