In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier to trial participation, digging deep into demographics and distribution of trials across US counties, as well as offering an interactive map tool filterable by therapeutic area. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations rising and many moving parts threatening to put data at greater risk than ever before. Dan Ayala, chief security and trust officer for Dotmatics, an R&D software developer, talks about the challenges of today’s data landscape in the first of a two-part series. Read More
A newly launched NIH program puts an ambitious focus on bridging clinical research with primary care practices, especially those in underserved communities, a mission that can help reach underrepresented patients, build trust, make advancements on common health issues and bring more investigators into the fold. Read More
Sites appear less informed and prepared than sponsors for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company.
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The European Medicines Agency (EMA) is continuing efforts to improve trials in the trade bloc, announcing two new programs that will offer support on clinical trial applications as new transparency rules under its Clinical Trials Information System (CTIS) come into effect. Read More
Recent years have shown AI’s potential for advancing drug development is undeniable, with hundreds of drug submissions to the FDA referencing AI solutions. But AI’s integration in trials must be balanced with careful considerations for a number of unique challenges, says M. Khair ElZarrad, director of the Center for Drug Evaluation and Research’s Office of Medical Policy. Read More
Richard Birke, chief architect of alternative dispute resolution provider JAMS Pathways and an expert at resolving complex multiparty disputes, sat down with The CenterWatch Monthly to discuss conflicts that can arise within clinical research teams and effective approaches to putting these arguments to rest. Read More
Large sites, with more robust budgets, workforces and technology suites than smaller sites, are well-suited for driving meaningful change in clinical trial diversity. In this article, experts share tips for developing and honing DE&I efforts at large-scale sites that can be adapted for use by sites of all sizes. Read More
Adapting to the quality and risk management components embedded in the new ICH E6(R3) guidelines may present challenges for sponsors and providers, but it’s sites that may find the task particularly daunting, findings from an Avoca survey show. Read More