Many in the clinical trials ecosystem would like to see wider adoption of decentralized trial elements. “Yet, despite recent draft guidance from the U.S. Food and Drug Administration, as an industry we haven’t made huge strides in adopting this model for interventional studies,” notes Noelle Gaskill, Head of Clinical Research Collaborations at Mirati Therapeutics, Inc.
Clinical research is in the midst of a serious talent shortage — a challenge the industry can expect to face for the next several years. Some experts predict the global labor crunch will last at least into 2030, when most baby boomers will have left the market, but younger workers won’t yet be prepared to step into vacated roles.
The process of assessing clinical trial feasibility is in urgent need of improvement. Aimed at predicting whether a trial at a particular site will succeed, feasibility involves determining whether the site has the necessary patients, staff, technology and other resources. In turn, site staff must decide whether the site should accept the study based on available resources.¹
Maintaining patient engagement and minimizing dropout rates in clinical trials is a persistent hurdle, with dropout rates soaring up to 30% in some studies. Traditional methods often fall short in addressing the needs and concerns of participants, leading to disengagement and, ultimately, withdrawal from the trial. However, purpose-driven eClinical solutions, like ENGAGE!, an integrated MyStudyManager™ Participant Portal and eConsent system, offer a more patient-centric approach that presents a promising avenue for recruiting and retaining patients for long-term engagement in clinical studies.
Advances in diversity, equity, and inclusion (DEI) demand more than simply offering people from underrepresented populations a seat at the table. “While this is a good starting point, we must also take a close look at what happens at that table,” says Ashley Moultrie, CCRP, Director of DEI and Community Engagement at Javara. “Success depends on what happens next.”