In a 2017 ResearchAmerica! poll of 1,000 people, roughly 9 in 10 said that they would like clinicians and other health care workers to discuss clinical trials with them if they were diagnosed with a disease. However, more than 7 in 10 said they had never been approached about clinical research.
Developers of new treatments and devices would like to make trials more available at sites across the nation. To bring breakthrough therapies to the clinic, they must enroll enough patients in these multisite trials for their findings to be valid and generalizable. Difficulties enrolling patients can delay the trials and add to their price tag.
However, finding clinicians to implement those trials at medical centers can be challenging. Many clinicians would like to be able to offer their patients a robust selection of clinical trials but are often overwhelmed with clinical duties and lack time and training.
The South Carolina Clinical and Translational Research (SCTR) Institute, with an academic home at the Medical University of South Carolina (MUSC), set out to address these barriers by establishing its Clinical Trialist Training Program (CTTP).
"We wanted to give investigators a good runway to be able to ramp up and be successful," said Tammy Loucks, Dr.PH., SCTR science development officer and associate director of the workforce development program.
CTTP was first established in 2021 through a collaboration between SCTR's multi-site clinical trials team and its workforce development program, as well as other MUSC research support offices. The one-year program provides early-career clinical faculty the protected time and robust training they need to establish a sustainable portfolio of clinical trials. The SCTR teams describe the program and its early successes in a July article in the Journal of Clinical and Translational Science.
"Participating as a site investigator in a large multicenter clinical trial has become more challenging for doctors because of increased regulatory requirements and clinical demands," said Marc Chimowitz, MBChB, director of the multisite clinical trials team at the time of the program's inception. "This led us to develop the CTTP to identify, train and support busy clinicians to become effective site clinical trialists, who are a key component of a successful multicenter trial."
Tanya Turan, M.D., who directed the program during its first two years before passing the baton to Andrew Goodwin, M.D., is excited about how those trained in the program can "pay it forward" for their patients and colleagues.
"The CTTP provides a jump start for the participating clinicians by giving them protected time and training to develop a clinical trials portfolio at MUSC successfully," she said. "The result is that the clinicians can offer more clinical trials to patients and help to mentor the next generation of trialists to do the same."
Aware of the time constraints on young clinical faculty, CTTP leadership knew that it was a critical first step to ensure scholars had the protected time they needed for clinical research and training. They consulted with Raymond DuBois, M.D., Ph.D., then dean of the College of Medicine and current director of the Hollings Cancer Center, who pledged to cover 10% of the scholars' salary so that they could devote that time to the program and their research.
"This program is crucial in providing individuals with enough time to develop their clinical research skills," said DuBois. "This is an outstanding program that MUSC is very proud of and will continue to support in the future to provide a pipeline of future clinical investigators." Current COM dean Terrence Steyer, M.D., is also very supportive of the program.
"Participating as a site investigator in a large multicenter clinical trial has become more challenging for doctors because of increased regulatory requirements and clinical demands."-- Dr. Marc Chimowitz
During the one-year program, scholars attend "meet the expert" presentations and discuss strategies and troubleshoot problems regularly with their mentors and SCTR staff. In addition, they are expected to meet quarterly milestones.
During the first quarter, they attend a clinical trials boot camp, also open to other faculty on campus, where they are introduced to the offices and resources relevant to clinical trials on campus. With the help of SCTR's multisite clinical trials team, they also select a trial that is a good fit for their interests, patient population and departmental needs. During subsequent quarters, they interact with the multisite trials team to learn how to assess whether a trial is feasible (quarter 2), obtain necessary approvals and execute contracts (quarter 3) and finally recruit patients for the first trial while beginning the approval process for the next trial (quarter 4).
"We wanted to give investigators a good runway to be able to ramp up and be successful."-- Dr. Tammy Loucks
"It's a combination of having the support, the protected time and the quarterly progress meetings that makes the program a success," said Diana Lee-Chavarria, SCTR workforce training and development manager. "The progress meetings are led by scholars, so they can come with questions or just ask for feedback on something."
The CTTP training also improves the efficiency of clinical trials.
"The CTTP provides a jump start for the participating clinicians by giving them protected time and training to develop a clinical trials portfolio at MUSC successfully."-- Dr. Tanya Turan
"If the scholars get stuck, they know exactly who to go to with that question to get it answered so that they can move past that hurdle and keep the trial running efficiently," said Signe Denmark, associate director of research opportunities and collaborations.
"This is an outstanding program that MUSC is very proud of and will continue to support in the future to provide a pipeline of future clinical investigators."-- Dr. Raymond DuBois
The program's goal is for the scholars to be able to sustain the 10% commitment to research with the clinical trial portfolio they develop during and after the program.
The inaugural cohort (2021-2022) of four CTTP scholars reached all milestones and launched nine clinical trials totaling $2.2 million. Although they had not received enough funding to cover 10% of their time by the end of the program, all thought they were on course to do so in the near future.
Since then, six additional scholars (2022-2023) have been trained and another four (2023-2024) have been accepted and have recently completed orientation.
The feedback from scholars has been very positive. "Before participating in the program, it was challenging to find sufficient time out of my busy clinical schedule to be a successful clinical trialist," said Kelli Williams, M.D., associate professor of Pediatrics.
"Participating in the program not only afforded me dedicated time to be more active in recruiting and initiating studies, but it also provided me with fundamental knowledge on all aspects of the process of securing trials."
The program has also enabled academic departments to build their clinical trial portfolio.
"Participating in the program not only afforded me dedicated time to be more active in recruiting and initiating studies, but it also provided me with fundamental knowledge on all aspects of the process of securing trials."-- Dr. Kelli Williams
"It's good for academic departments to be able to have investigators with different research interests," said Loucks. "It helps build the depth in the department and then by default provides more clinical trial options for patients."
It's also helped MUSC as an institution to strengthen its clinical trial offerings. "We've been able to expand several new indications that we didn't have a footprint in before, such as rare pediatric diseases," said Denmark. "We now have more trial opportunities available for patients than before the program."
Reference
Loucks, T., Lee-Chavarria, D., Harvey, J., Paranal, R., Denmark, S., Flume, P., . . . Turan, T. (2023). Preparing clinicians to be site investigators in multicenter clinical trials: A training program at an academic medical center. Journal of Clinical and Translational Science, 7(1), E167. doi:10.1017/cts.2023.587
