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Representation and diversity in clinical trials

For decades, clinical trials have been considered the gold standard in medicine. For regulators, providers, payers, and patients to trust a new treatment, it must first be proven safe and effective in a clinical trial.

But clinical trials have historically fallen short in a critical way: They aren’t diverse enough. Many trials fail to recruit people of color as participants. Some studies skew heavily male, and others exclude older adults. Most do not allow pregnant and lactating women to enroll.

It’s an issue that has taken on new significance during the Covid-19 pandemic, which has led to the launch of hundreds of clinical trials testing potential vaccines and therapeutics against the novel virus. Without real representation, it’s difficult to determine how well a therapy might work in certain populations — or whether it might pose an additional risk to a particular pool of patients.

Here, STAT has collected a range of coverage on equitable inclusion in clinical trials. The stories underscore not only the need for a more diverse pool of participants in research, but also lay out the steps it will take to move the needle toward more representative trials.

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PRA is a global healthcare intelligence partner, developing life-saving and life-improving drugs with our comprehensive clinical development and digital health services, including but not limited to data management, site and decentralized clinical trial management, statistical analysis, medical writing, and regulatory and drug development consulting.