Wednesday, 29 March 2017

Are Clinical Trials Diverse Enough to Ensure Patient Safety?

The latest data from FDA shows that clinical trials may not include enough ethnic and gender diversity, which could put patient safety at risk.

A new FDA report indicates that clinical trials may not be accurately representing real-world demographic patterns, leading to concerns that new drugs are not being accurately tested for patient safety and effectiveness. Only 48 percent of drug testing populations consisted of women, and only 7 percent of those who participated in clinical trials were African Americans.

White patients accounted for 76 percent of the test population, while participants over the age of 65 only accounted for 21 percent and just 11 percent were Asians. The imbalance of demographic identities may not accurately portray the health needs for diverse communities across the US.

“Over the past two years, FDA’s Center for Drug Evaluation and Research (CDER) approved 67 novel drugs, said John J. Whyte, MD, MPH, Director of Professional Affairs and Stakeholder Engagement at FDA’s Center for Drug Evaluation and Research.

“So it’s no surprise that in recent years, representation in clinical trials of certain subgroups, such as people of different ages, races, ethnic groups, and genders, has become of growing interest.”

Certain drugs may have different dosages for men and women, or impact patients in different ethnic groups in distinct ways. Because of these variances, it is important to test new therapies on a variety of patients representing the full spectrum of patients likely to take them.

The FDA report indicates that researchers are working to incorporate more diverse patients in clinical trials, said Whyte.

“[The report] shows for example, that women were represented at a rate of 40 percent in 2015 and 48 percent in 2016 and African Americans were represented at a rate of 5 percent in 2015 and 7 percent in 2016,” he said.

However, many trials for new drugs are still unbalanced.

Eighty-six percent of the patients involved in one clinical trial for Lartruvo, a drug that treats soft tissue sarcoma, were white. African-Americans accounted for 8 percent and Asians accounted for 3 percent of the sample population.

Ninety-one percent of the enrollees in a clinical trial for Nuplazid, the only FDA approved drug to treat Parkinson’s-induced hallucinations, were white males. Only one percent were African American, and women represented just 36 percent of the sample patient population.

Three-quarters of patients in a trial for Adlyxin, used to treat type 2 diabetes, were white. Women only represented 31 percent of the clinical trial population, and only four percent were African-American.

Key factors for demographic disparities in clinical trials include a lack of enthusiasm for patients to participate, a need for improved patient engagement strategies, and an ongoing need for clinical innovation.

Last year, the Memorial Sloan Kettering Cancer Center found that 65 percent of patients are not likely to volunteer for research purposes. The organization suggested that communicating an immediate personal gain for those who take part in a trial may increase participation.

Patient engagement strategies such as utilizing mHealth tools can make it easier to encourage people from all walks of life to participate in clinical trials. The NIH’s All of Us Research Program, for example, relies on active community support to increase diversity-based data across age and socioeconomic differences.

Researchers and organizations like the FDA can address the needs for more diverse testing groups and build testing populations that paint a more accurate picture of US demographics.

“Until the late 1980s, clinical trials were conducted predominantly on men,” Whyte said. “Much has changed since then. Our Drug Trials Snapshots program and Summary Report underscore FDA’s commitment to enhancing transparency and better understanding of patient representation in clinical trials.”

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