Inspired by lackluster efforts to improve diversity, equity and inclusion (DE&I) in clinical research, two centers at the University of Pennsylvania (UPenn) have moved to publish the core methodologies and practices they developed to boost DE&I within their trials. Read More
Patient response to new digital components in the electronic informed consent (eIC) process is overwhelmingly positive, with nearly three-fourths of respondents to a recent survey saying they find enhanced eIC more personable, engaging and informative. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
Since 2021, patients have grown considerably more amenable to taking part in clinical trials, a new survey by the Center for Information & Study on Clinical Research Participation (CISCRP) has found. Read More
A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another. Read More
The utilization of websites for trial recruitment has nearly tripled since 2019, while social media platforms and patient advocacy groups have doubled in use, according to a study that offers new insights into the top recruitment methods used for trials postpandemic, among other data. Read More
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