Visit the new Clinigma® website today.
We are very excited to announce that our new and refreshed website www.clinigma.com is now live. The updated site includes all the information you need to learn more about the expertise and capacity of Clinigma®. For instance, it includes a section dedicated to giving you a better understanding of our unique IT portal facilitating secure and easy collection of patient feedback from clinical trials.
Click here to visit our new website and learn more about Clinigma®.
Increasing the use of qualitative research methods in clinical trials.
At Clinigma®, we are not the only ones recognizing the value of listening to the patient’s voice in clinical trials.
Increasingly, regulatory agencies – led by the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) – are acknowledging the value that patient feedback can contribute to medical product development. As part of an effort to enhance the incorporation of the patient’s voice in clinical trials, FDA has even developed Patient-Focused Drug Development (PFDD) guidance to capture patient feedback in clinical trials, and EMA will start developing similar guidances following the EMA regulatory science strategy 2025.
Furthermore, a systematic review that we did back in November 2019 reveals an increasing trend in the use of qualitative research methods in clinical trials. This means that trials are now beginning to use interviews to report on patients’ experiences of investigational drugs. Conducting patient interviews is highly valuable in order to explore the subjective experiences of clinical trial participants in more depth than found possible with quantitative approaches.
If you would like to know more, please click here to contact us.
