20 Dec Innovate to increase diversity in cancer clinical trials

By Arturo Loazia-Bonilla, The Association of Clinical Research Professionals

The fight for fairness and equity in medicine took a dramatic step forward last June, when the U.S. House of Representatives passed legislation intended to increase the racial and ethnic diversity of patients enrolled in clinical trials of new drugs. The proposed law would require sponsors of clinical trials to develop and submit diversity action plans describing their goals and strategies for achieving demographic equity in Phase III studies of novel therapies.

Lack of diversity in clinical research is not a new problem; the U.S. Food and Drug Administration (FDA) has periodically issued guidance calling for greater inclusiveness in clinical trials since 1988. However, while new regulations and incentives for sponsors may help, no negative actions have been taken in the FDA’s oncology review divisions in cases of sponsor failure to conduct more diverse trials, and vague diversity guidance continues to raise concerns.

Lola Fashoyin-Aje, associate director of the FDA Oncology Center of Excellence and deputy director of the Center for Drug Evaluation and Research’s Division of Oncology III, said that the agency recognizes clinical development does not stop at application approval, adding that in some cases more studies may be necessary if diversity targets are not met. Read more …