A 2023 analysis conducted by clinical research analytics firm Phesi shows that breast cancer was the most heavily researched disease area for the third year in a row, followed by solid tumors and stroke. Read More
A survey conducted by the Clinical Trials Transformation Initiative (CTTI) indicates a large part of the lack of reported trial results in the U.S. is due to investigators’ and other stakeholders’ limited understanding of the requirements and processes for registering and submitting trial data to the ClinicalTrials.gov database. Read More
Billing federal healthcare programs for ineligible clinical trial-related items over a six-year span has landed a Tampa, Fla., cancer research hospital in hot water with the government, but the nonprofit site has reached a $19.5 million settlement after admitting responsibility for the billing issues, working with the government and taking action on its own. Read More
As 2023 draws to a close, the FDA has issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and using real-world data sources, as well as a new draft guidance on clinical trial master protocols. Read More
Staffing and retention topped the list of site struggles in 2023, with such terms as “rusting out,” quiet (and loud) quitting and “bare-minimum Mondays” now figuring prominently in the workforce lexicon. To weather these challenges, sites should cross-train their staff on all aspects of their protocols, experts say. Read More
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