**Author details**

An alternative to financial incentives to improve clinical trial diversity would be a stronger stance by governing and regulating bodies such as the NIH and FDA. The FDA recently implemented the "Food and Drug Administration Safety and Innovation act" (FDASIA). Section 907 of this act directs the FDA to investigate how well demographic subgroups (sex, age, race and ethnicity) in applications for medical are included in clinical trials; and if subgroup-specific safety and effectiveness data are available. While this does not create a mandate for inclusion like the NIH revitalization act of 1993, it is an important step forward in improving clinical trial accrual of under-represented populations. But, given the size of the disparity, a more aggressive stance is required. Laws implemented by the NIH and FDA 10 years ago would have had potentially significant effects on diversity within clinical trials because the government (NIH) was the major funder of clinical trials at that time. However, the major funder of clinical trials in the United States today is the pharmaceutical industry. If the goal is to create policies to change research behaviors in clinical trials today, those policies must take a stronger stance in terms of requirements for new drug approval or creatively and ethically consider what is valued by the main funder of clinical trials; industry. The literature has previously discussed in great detail the issue of financial incentives to increase clinical trial diversity. Now is the time to begin a discourse on the role of an FDA mandate on clinical

A mandate on diversity by the FDA would be a powerful motivational factor for the pharmaceutical industry to increase clinical trial diversity. A FDA mandated minimum level of diversity (or diversity benchmark) within clinical trials could be applied to research within areas of medicine where there are known issues in terms of health disparities (hepatitis C, cardiovascular disease, diabetes). Through the creation of an expert panel, the need for specific emphasis on diversity within certain populations could be assessed. For example, an FDA or industry appointed expert panel on cardiovascular disease could mandate that phase 3 clinical trials on hypertension medications need to establish a minimum level of diversity in terms of African American participation, given the disparities that exist in hypertension control among African Americans. Those trials who successfully reach the diversity benchmark could be eligible for an expedited approval process and those that do not reach the benchmark would receive the equivalent of a black box warning concerning the lack of data in diverse populations. Exceptions could be made in those scenarios where earnest attempts

The benefits and risks of improving diversity by any mandate or benchmark would have to be weighed. There is a potential for impeding clinical research due to the time required to achieve diversity. Furthermore, financial resources would be required to invest in the accrual of diverse populations. The expertise of thought leaders would be key to identifying those clinical trials which should have to reach diversity benchmarks as well as what precisely those diversity benchmarks should be. But achieving a consensus on what types of clinical trials require diversity benchmarks and what those benchmarks should be would require close collaboration between regulatory entities (FDA) and the pharmaceutical industry. Although there would be pros and cons with the implementation of such a policy, previous policies which have taken a less assertive stance have not addressed this important issue and the pharmaceutical industry has not shown a propensity for addressing the issue on their own.

at accruing diverse populations were attempted but unsuccessful.

trial diversity.

8 Clinical Trials in Vulnerable Populations

Julius M. Wilder

Address all correspondence to: julius.wilder@duke.edu

Duke Division of Gastroenterology, Duke Clinical Research Institute, United States
