The FDA and the EMA are strengthening Patient-Focused Drug Development
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both acknowledge that the incorporation of the patients’ voices in drug development is essential, and should be integrated systematically to ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.
As part of an effort to facilitate advancement in the collection of patient experience data and thus enhance the incorporation of the patients’ voices in clinical trials, the FDA has developed Patient-Focused Drug Development (PFDD) guidance documents, and the EMA is expected to start developing similar guidance documents following its Regulatory Science Strategy to 2025.
The FDA PFDD guidance documents address how to collect and submit patient experience data for drug development and regulatory decision making. The FDA’s PFDD guidance documents will be finalized within the coming years and will come into effect as soon as they are finalized. Each guidance document will address a specific topic, including:
- Sampling methods to use for the collection of comprehensive and representative patient input.
- Methods for capturing information when conducting qualitative research.
- Selection/development of fit-for-purpose Clinical Outcome Assessments (COAs).
- Ways to incorporate Clinical Outcome Assessments (COAs) into clinical study endpoints.
If you want to read more, please click here to see an outline of the FDA’s planned timeframe for issuance of Patient-Focused Drug Development guidance.
Next week, we will brief you on key points in EMA´s Regulatory Science Strategy to systematically integrating patients’ preferences to inform drug development and regulatory decision making.
Do you know how to act upon the regulatory guidances on Patient-Focused Drug Development?
At Clinigma®, we support pharmaceutical companies in capturing patient feedback during clinical trials in accordance with the regulatory requirements from the FDA and the EMA. We are exclusively specialized in interviewing clinical trial patients with the purpose of gathering the critical insights that patients and caregivers can bring to the drug development.
In addition, we have developed the Clinigma® Portal – a client-tested IT portal facilitating secure and easy collection of patient feedback at any stage of the drug development process.
A secure tool to facilitate the patient interview process
The Clinigma® Portal is developed to remove all the hassle of conducting patient interviews in global clinical trials. Importantly, the Clinigma® Portal ensures that information collected from patient interviews is stored in a secure online environment.
To ensure the security level of the Clinigma® Portal, we have had a global cyber security consultancy, NCC Group, to perform a security assessment resulting in the highest achievable security score:
“The high level of security awareness demonstrated
emerges from the various security controls in place to minimize
and counteract potential risks to the application and its users”
– NCC Group
Click here to read more about the Clinigma® Portal.
