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
The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from GCP Questions, FDA Answers, a book from CenterWatch, a WCG company. Read More