Is the FDA Making the Right Moves on Clinical Trials?

Recently, the FDA announced new provisions that require sponsors to submit Diversity Action Plans. But what does that mean for the average person?

“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”

But the new FDA provisions only require diversity action plans for phase 3 clinical studies.

As a 13-year survivor of triple-negative breast cancer and passionate breast cancer advocate, I applaud the FDA’s response to the critical need for diversity in clinical trials. However, this current guidance falls short of making a substantial impact and is only a preliminary step towards what truly needs to be done.

What is a Phase 3 clinical trial?

According to FDA.gov, this is the current process for drug development:

Phase 1

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Purpose: Safety and dosage

Approximately 70% of drugs move to the next phase

Phase 2

Study Participants: Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

Purpose: Efficacy and side effects

Phase 3

Study Participants: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Approximately 25-30% of drugs move to the next phase

Based on this process, the safety, efficacy, dosage and all the most critical characteristics of a drug and how it is administered are determined in the first two phases of drug development. By phase 3, the drug development is near completion.

Diversity can’t be an afterthought

Waiting until phase 3 to mandate a diversity plan is much too late. If the safety, efficacy, and dosing are not tested on the patients most afflicted with the disease at every stage of development, then we are missing critical data.

Frankly, clinical trial participation should be commensurate with the burden of disease. Drugs should be developed for the patients who need them, with their bodies, their biology, and their disease in consideration from the get-go.

Ricki Fairley, CEO and co-founder of TOUCH BBCA

Black women are 41 percent more likely to die of breast cancer than white women. Black women have a 39 percent higher recurrence rate than white women. Black women are more likely to die of breast cancer than white women at any stage, any age, and any subtype. Black women are diagnosed with triple-negative breast cancer at three times the rate of white women. We now have a growing body of research that validates a Black breast cancer cell has significant differences from a white breast cancer cell based on genetics, genomics, environment, and social determinants of health.

“Precision medicine has allowed for a more targeted approach to oncology treatment because we recognize that cancers coming from similar tissue origin can have different characteristics, drivers, and response to therapy,” explains Dr. Gregory Vidal, M.D., Ph.D. “Some of these differences may have racial, ethnic and environmental origins which we can only identify through directed studies. To do so, we must enroll diverse populations of patients at every stage of drug and biomarkers development.”

Yet, the clinical trial participation rate for Black women is roughly 3 percent. The breast cancer drugs that we currently have as standard of care are not working the way they should for Black women because they were not tested on our bodies.

Where advocacy meets policy

As the CEO and Co-founder of TOUCH BBCA, I am passionately seeking the systemic changes that will actually make a favorable impact. We know we can motivate Black women diagnosed with breast cancer to apply for trials, but without policy that motivates clinical trial sponsors to address institutional and structural barriers to access around clinical trials, we won’t move the needle. We urge the FDA to consider their new provisions a brief and initial step that culminates in mandating pharmaceutical companies and clinical trial sponsors take diversity seriously from the very beginning of drug development.

TOUCH, The Black Breast Cancer Alliance