How Effective is FDA’s Push for Diversity in Clinical Trials?
[Posted on: Thursday, June 23, 2016] Last week FDA launched a new campaign to encourage minorities in the US to participate in clinical trials using video clips of a minority participant of clinical trials. FDA declared 2016 as “The year of Clinical Trial Diversity”; this is one of several initiatives launched this year. However, it seems these measures will have little practical effect on increased minority participation, at least in the near future. Minority participation in clinical trials is a multi-dimensional issue. Historical, cultural and economical reasons have limited participation of minorities in clinical trials. Any campaign to encourage patient participation needs to address all these issues. FDA does acknowledge this by seeking a community of “Clinical Trial Champions” and provides tools to this community to educate the general public. But it does not seem very emphatic from a minority participant point of view. Minority communities have a high perception of being taken advantage of by clinical trial sponsors, and that they could get hurt by participating in trials. An important part of education should be about the laws that protect them. On FDA’s webpage on minorities in clinical trials, which is intended to be printed and used for minority education, FDA should have emphasized that it plays a major role in assuring that the clinical trials are safe for their participants. Rather, that point is muted; instead it is emphasized that “FDA Does not Conduct Clinical Trials”. It would be important education for the minority communities that there are many laws written in the last four decades specifically to assure human subject protection in clinical trials and that FDA enforces these laws. Due to these FDA-supervised laws, incidence of patient injury in clinical trials is a rare event these days. Another very important way to increase minority participation is by forming community groups, community advisory boards, partnering with minority churches, and having experts talk with the community about how the disease being studied was affecting their community. Strong support of minority physicians is known to increase minority participation in clinical trials. There is need for training of minority physicians as clinical investigators. It is well-known that minorities participate at a much higher level in Phase 1 clinical trials, however, for Phase 2 and 3 the participation drops dramatically. Minority physicians can play a critical role to address this concern due to higher level of patient-physician trust. From a regulatory point of view, approval of a drug is not critically dependent on data from minority populations. In a report by FDA a few years ago, it was found that most market approval applications there was insufficient data on patient subgroups for meaningful analysis or to detect relevant subgroup effects. However, the report indicated that information on diverse populations would not always influence FDA’s decision on clearance of products. In cases where data from diverse populations is critical, this data can be generated from other countries where these communities form the majority of the populations such as recruiting patients in South America to get data from Hispanic populations. As such, there is little pressure on the industry to go out of its way to increase minority participation in the US as regulatory concerns can be addressed by other easier solutions, leading to the current status quo. FDA’s attempt to increase discussion on this topic is laudable but it needs active collaboration from the industry and physicians. It may take much longer than we all desire for. FDA needs to do more.
|
|