Pharmaceutical companies should have more diverse clinical trials: FDA

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US June 14, 2019

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A draft guidance from the FDA calls on companies to consider nontraditional factors, such as geography, education and income, to increase trial diversity. In its draft guidance, the FDA urges companies to consider locating trial sites in locations with higher concentrations of racial and ethnic minorities.

The agency’s proposal also suggests companies hold trial recruiting events during evening and weekend hours to attract working adults and to consider recruiting sites such as churches and barbershops.

Recruiting events that are limited to working hours or medical settings may exclude those disproportionately more likely to work a second job or have less exposure to the medical system. Broadening recruitment efforts to locations more likely to be frequented by racial or ethnic minorities may similarly broaden exposure of these populations to the possibility of beneficial clinical research.

The FDA also said it would like to see greater participation by patients across disease severities and ages. This is particularly true of phase 3 trials in which companies typically have more knowledge about the expected effects of their experimental products.

The FDA did acknowledge that excluding certain participants may be necessary or justified, such as when a trial participant develops organ failure, making it more likely the drug could harm them.

HRI impact analysis

Regulators—and companies—often don’t know how subgroups of patients might react to a drug until it is released into the real world. Some ethnicities, for example, metabolize drugs differently due to genetic differences.

Elderly patients may not metabolize drugs as effectively due to the effects of aging or may experience more side effects due to their organs operating less efficiently. Children remain an understudied group. Pregnant women may be excluded entirely for fear of the drugs’ effects on the fetus.

The FDA’s concerns are that some companies are either improperly limiting access to trials to all but the most likely to benefit or are failing to take the effort to recruit patients from more racially or ethnically diverse populations, depriving both regulators and the public a full accounting of the worth—or risks—of how drugs may affect these populations.

Ultimately, greater diversity in clinical trials will benefit patients by increasing the evidence that the medications they take are safe and effective for them. For companies, this could increase their trial costs by making it more difficult to recruit or obtain patients but is unlikely to significantly impact costs.

Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

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