The Clinical Trials Transformation Initiative (CTTI) unveiled new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.
“One thing we’ve seen from our work in this area is that there’s no shortage of physicians interested in participating as trial investigators,” said Duke cardiologist Dr. Matthew Roe, co-team leader for CTTI’s Investigator Community Project. “The problem is that leading a trial is complex and the learning curve is steep. If you’re new to the field or you don’t have mentors, training, and infrastructure to support you, the burdens can quickly become overwhelming and lead to an investigator only doing a single trial—something we call ‘one and done’. Then the imperfect cycle begins again with a new investigator.”
Drawing on combined experience and insight from investigators, sponsors, CROs, patients, regulators, and representatives from clinical research professional societies and trade associations, CTTI identified the key challenges facing investigative sites.
“For an investigator to effectively manage their site and study there are many elements that must be given serious consideration—and are often unknown at the onset of the first study—to ensure they do not become a ‘one and done,’” said Christine Pierre, president of SCRS. “These recommendations help guide that direction for the site and the rest of the industry. The true impact will only be realized when all stakeholders embraces these recommendations.”
Although the CTTI recommendations were tailored for action by different stakeholders—investigators, sponsors, contract research organizations, and health systems—strategies such as supporting continuous training, maintaining clear communications and operational procedures, and fostering a climate of mutual respect emerged as cross-cutting themes.
“These recommendations are a blueprint for creating a system that supports successful and sustainable clinical trials,” noted Sheryl Jacobs, vice president of Global Development Operations at Amgen. “The Investigator Community Project provides straightforward, actionable steps that the biopharmaceutical industry can take to ensure that clinical research remains an attractive arena for skilled and talented people looking to make a difference in patients’ lives.”
The new recommendations will be the focus of a panel discussion taking place at SCRS’ Global Site Solutions Summit on Oct. 7 from 4:30-5:30 p.m. EDT. CTTI will also present the recommendations during a public webinar on Oct. 19 at noon EDT.
Global Funding for this project was made possible, in part, by the FDA through grant 5R18FD005292-04, views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices or organization imply endorsement by the United States Government.