In 2005, the FDA issued its Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials. The development of biopharmaceutical and medical companies are now more then ever facing scrutiny to be more proactive to ensure the patient population of their development programs closely match the target population of their product candidates. We understand that ethnic minority patients are mostly seen by minority physicians and physicians with an interest in these populations. We maintain close relationships with these physicians, so they are ready to enroll when we work on studies target minority populations. In our experience, study investigators who have access to ethnic minority patients perform very well in these studies, tend to enroll faster and patients tend to stay in these studies until the end and be compliant with the study protocol.
Enclosed please find a PDF copy of the FDA’s Action Plan to enhance the collection and reporting of demographic data in submissions for CDER, CBER and Medical Devices Applications. This document summarizes the activities that the FDA plans to execute to address the issue of poor demographic data (age, sex and race/ethnicity) submitted with drug or device applications and it is a response to a large body of work done over many years by very many different organizations and individuals putting pressure on the US Congress and the FDA to make significant changes in the way it asks Sponsors to collect and report such data.DOWNLOAD THE PDF