The limitations of Patient Reported Outcome Measures (PROMs)
Traditional PROMs (consisting of closed-end questions) have for many years been applied to reveal the patients’ experiences of effects that you expect to find when testing a new drug. Yet, traditional PROMs are developed based on the existing therapies and thus have limitations in providing the full picture of a novel treatment with novel features. In this way, by applying traditional PROMs there is a risk that you overlook important patient benefits or challenges. Maybe another set of PROMs could have captured the trial patients’ responses on the product attributes in a better way?
In addition, PROMs are limited in the sense that they are not able to provide an understanding of how the experienced effects are relevant and meaningful to the trial patients when testing the investigational drug in the clinical trial.
By interviewing the users who have tested a new drug in a trial program, you can minimize the risk of overlooking important patient benefits or challenges and at the same time get a better understanding of how the patients experience and value the effects of your investigational drug.
Minimize the uncertainties of drug development and approvals
At Clinigma®, we have a unique IT portal facilitating secure and easy collection of trial patient feedback as well as a large global team of qualitative researchers with the ability to interview trial patients in more than 70 languages. In this way, we are able to support pharmaceutical companies in capturing invaluable insights directly from the trial patients who have tested an investigational drug. Direct user feedback minimizes the uncertainties of drug development and regulatory approvals as it enhances the quality of insights into the benefit/risk assessment of an investigational drug.
Click here to learn more about our expert solutions in capturing trial patient feedback.
