Sponsors of drugs being developed to treat or prevent COVID-19 should strive to enroll populations at greatest risk in their trials, including older adults, ethnic and racial minorities, children and pregnant/lactating women, the agency advises in a straight-to-final guidance. Read More

This monthly feature presents questions from clinical trial professionals with answers from experts. This month features insights from Sheri Spivey and Lindsay Abraham, regulatory chair directors for WCG IRB. Read More

From phase 3 trials to mergers/acquisitions and novel therapy approvals by the FDA, the biotech industry has seen a massive boom in the past decade. A new Tufts Center for the Study of Drug Development (CSDD) study reveals that the amount of biotech products in late-stage research has skyrocketed in the past 10 years, among other findings. Read More

Increasing cultural and ethnic diversity in Alzheimer’s clinical trials is a must — but it’s going to take a complete rethinking of the way these studies are recruited, conducted, and analyzed, said a Fordham University psychology professor speaking at an Alzheimer’s conference. Read More

The diversity, equity and inclusion (DE&I) movement in clinical research has progressed significantly in the past few years, moving from discussing barriers and potential solutions in 2020 to taking real action this year and the last, LaShell Robinson, Takeda’s head of DE&I in clinical research, told attendees at the 2023 WCG Patient Forum last week. Read More

Obesity’s impact on drug pharmacokinetics and the prevalence of the disorder and its associated comorbidities warrant greater inclusion of obese patients in clinical trials, experts say in a recent opinion piece, yet this group too often goes unconsidered and unevaluated. Read More

This monthly feature presents questions from clinical trial professionals with answers from experts. This month features insights from WCG Vice President of Client Delivery Cristin MacDonald. Read More

In this thought leadership piece for CenterWatch Weekly, Jonathan Seltzer, executive director of the Cardiac Safety Research Consortium (CSRC), a partnership of industry, government and academic leaders, discusses the use of remote patient monitoring in cardiac clinical trials. Read More

The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More

U.S. patients with lower education and annual household income are less interested in and familiar with participation in clinical trials, according to a new study that recommends examining such socioeconomic factors when planning trials. Read More