Industry stakeholders are pessimistic about the state of the CRA workforce and don’t believe progress has been made in combatting shortages, underscoring the need for innovation in how CRAs are trained and evaluated, according to a recent survey.
Clinical research has seen marked upheaval in just a few short years as traditional methods were rethought and innovative changes enacted. In 2023, the industry can expect significant progress in the use of artificial intelligence (AI), decentralized and hybrid trials, and site-enabling solutions, as well as further efforts to combat ongoing recruitment and workforce challenges. The CenterWatch Monthly polled a variety of experts on these and other topics. Here’s what they had to say. Read More
FDA Commissioner Robert Califf has called for major reform of the clinical research enterprise, particularly in how clinical evidence is gathered, to reduce health disparities between scientific advancement and actual U.S. life expectancy, a huge undertaking that some clinical trial experts question. Read More
Time and effort have their own value and should be budgeted and billed for just as more tangible costs — tests, patient visits, trial supplies, etc. — are, say budgeting and contracting experts who warn sites about letting these intangibles slip through cracks in their systems. Read More
Sponsor and CRO acceptance of site input drives site satisfaction, according to a new study that shows sites are three or four times more likely to have a positive view of clinical trials’ future if their sponsors/CROs are open to feedback. But most still have concerns they would like to have addressed. Read More
Standard operating procedures (SOP) are not just necessary for keeping a trial on track, they are mandatory for the FDA and the first documents requested during an inspection. They must be clear, comprehensive and — most important — followed to the letter if a site is to survive close scrutiny.
Community engagement is a must-have component of virtually any diversity, equity and inclusion (DE&I) program, and one academic research center has pioneered a program that brings its community’s culture into its clinical trials.
An international group dedicated to fostering more complete, higher-quality trial protocols has released new guidelines that recommend nine characteristics of effective trial outcome reporting that can be applied to protocols regardless of a trial’s design or population. Read More
Identifying and communicating the stories clinical trial data tell is critical to delivering actionable insights, but it’s best to start small when organizing data into easily visualized images. Read More
A look back at the clinical trials landscape in 2022 shows that although record high levels of resignations, increasing scarcity of investigators and declining enrollment rates are slated to continue into 2023, the rate of trial starts appears to be stabilizing somewhat, giving sites a chance to possibly catch their breath in the new year. Read More