Sponsors and sites struggled with clinical trial diversity way before the Coronavirus pandemic began. Approximately 20% of new drugs have different effects depending on an individual’s race. This makes it important for newer treatments to be tested on a diverse patient population.
Yet disabled, elderly, Hispanic, and African American patients are typically underrepresented in clinical trials in the US.
The Coronavirus pandemic brought both gains and losses for clinical trial diversity. While many trials halted due to COVID-19, those that resumed didn’t do well in terms of recruitment. However, the COVID-19 vaccine trials of Moderna and Pfizer saw higher diversity than average for the clinical trial industry. They accomplished this diversity by working with a big network of community-based research sites across the world.
Sponsors and research sites must continue to fight for clinical trial diversity. To do this, they should learn from the studies conducted during the COVID-19 pandemic.
Increasing clinical trial diversity by building a strong site network
Around 70% of the US population lives more than a couple of hours away from an academic medical center. Often, this long travel time presents difficulties for:
- People who rely on public transportation
- People with hourly jobs
- People with disabilities
- Older people
People are now advocating for clinical trials taking place at community sites in underserved areas, instead of only at academic medical centers in big cities.
Often, smaller community sites don’t have the personnel or technology to run trials independently. However, with technology and regulatory help from coordinating centers, CROs, and sponsors, this can be managed.
For instance, a coordinating center may send online study start-up kits with document templates and folder & binder setups to community sites. The community sites may receive experience and funding from being a part of the research, and the coordinating center may gain access to a more diverse participant population.
This approach has benefitted a number of clinical trials, and it proved invaluable during COVID-19 pandemic.
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