Let’s Break Down the New FDA Guidance…

We discuss the Food and Drug Administration guidance about enhancing diversity in clinical trials: “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs,” which was issued last week.

Ensuring Vaccine Efficacy and Safety Requires a Diverse Participant Population

The timeline for vaccine development is lengthy and during a pandemic, resolution of the disease before a vaccine is approved can put development on hold indefinitely. Participant recruitment and engagement can help shorten the timelines.

Stop the Drop: Decreasing Patient Attrition Rates in Clinical Trials

To address patient attrition, sponsors and CROs must employ patient-centric solutions to help keep patients engaged and informed throughout the trial. In this blog post, we’ll cover ways to prevent attrition and improve communication with patients.

The Best Trials Are Diverse Trials

The diversity in clinical trials needs to reflect the diversity in the target population. Only then can we determine the safety and efficacy of drugs and medical products across all ages, races, ethnic groups, and genders that could benefit from the drug or product. However, diversity is hard to achieve and requires both strategic know-how and expert execution to deliver.

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