Insights

Clinical research trainers will tell you that not every trainee will flourish under the same kind of instruction—some excel in face-to-face classroom settings, some blossom with online courses, and guided reading or some combination of these with other learning methods will hit the spot in other cases. However, when it comes to learning how to effectively conduct the sensitive and mandatory process of informed consent with clinical trial volunteers, simulated consenting holds many advantages for trainees who are new to the concept.

Clinical researchers today need strong grant-writing skills to get their high-impact research projects approved and funded. Yet effective writing techniques typically aren’t taught in medical school, leaving many researchers struggling to create opportunities to further their work. That’s why the Harvard Medical School Postgraduate Medical Education’s Global Clinical Scholars Research Training program fills in the gaps to strengthen participants’ skills in this area and equip them with a valuable competitive edge to move the field forward. 

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 “Yet, despite recent draft guidance from the U.S. Food and Drug Administration, as an industry we haven’t made huge strides in adopting this model for interventional studies,” notes Noelle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.

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