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
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
The burgeoning AI space is bristling with potential for application in clinical trials, from study startup and recruitment to site monitoring visits, protocol simplification and greater operational efficiency overall. But widespread adoption will first require industry to properly evaluate and show the value of solutions in this still-evolving area. The CenterWatch Monthly reached out to several experts to gather insights on how AI is being used and what value it has for clinical trials.Read More
Making clinical trials truly representative of the disease populations they target is not an effort confined solely to the U.S. and FDA; it is a global initiative with many considerations that differ by country, culture and regulatory agency. The CenterWatch Monthly interviewed Liz Beatty, cofounder and chief strategy officer at Inato, a tech provider focused on boosting trial inclusivity and access around the world, to discuss thinking from an international perspective on diversity, equity and inclusion (DE&I).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
Problems can arise when sponsors isolate trial master file (TMF) management from the overall trial process by treating it as a separate activity. Utilize integrated technology to turn TMF management and procedures into opportunities to bolster trial success, a quality expert says. Read More
Diversity, equity and inclusion efforts need to look beyond racial, ethnic and geographic factors, according to a new study that shows a strong correlation of education and income to familiarity with trials and interest in participating. 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
