Optimizing Training for Future Clinical Trial Investigators

Clinical trial design is one of the primary pillars of drug development and cancer care infrastructure. However, most oncology fellows do not receive dedicated, standardized training in this area. To better educate fellows and facilitate their development into successful clinicians, regardless of whether they pursue academic careers, faculty at Washington University School of Medicine in St. Louis have designed and implemented a clinical trial development fellowship education program that they hope will serve as a model for other institutions.

“Clinical trial development and methodology education for fellows varies widely among programs,” Christine Auberle, MD, cochief fellow, hematology and oncology, Washington University School of Medicine in St. Louis, Missouri, explained in an interview with Oncology Fellows. “Clinical trials are important to what we do in oncology; this is how we get new drugs, treatments, and standards of care. But for fellows, there’s a lot of [variance] between what different fellowship programs offer, and there’s not a lot of structure. Our division leadership thought a potential solution was to [design] a program where fellows could get hands-on experience developing clinical trials with mentors who have experience developing clinical trials.”

The clinical trial development program at Washington University School of Medicine in St Louis mandated each participating fellow to identify a mentor and propose a minimum of 1 prospective investigator-initiated clinical study; the program was initiated in 2002. Fellows met with program leaders in the first 2 months of their fellowship and were offered suggestions for potential mentors. Throughout the first 6 months, they reviewed potential projects with faculty, culminating in the fellows drafting a letter of intent for their project of choice before the second half of the year.

After drafting their letter, fellows submitted their protocols to the institutional review board at the university. At the end of their first year, they presented their letter of intent for faculty feedback at an annual retreat. Fellows addressed review board critiques in their second year, after which patient enrollment was initiated contingent on regulatory and contract approval. During their second and third years, fellows presented progress reports for feedback during the annual retreats. Fellows were expected to analyze study data and prepare them for publication if their trial completed enrollment before graduation. They could also remain involved in their study if it closed after graduation.

In a retrospective analysis published in Academic Medicine, investigators presented the clinical trial development program results from 2002 to 2023. At the July 2023 data cutoff, 60 of 118 fellows who participated in the program had their studies published, of which 45%, 23%, and 5% were the first, second, and last authors, respectively. The median impact factor of the publications was 5.4, and 38% of publications appeared in journals with an impact factor above 10. Impact factor is a measure of the frequency with which the average article in a journal has been cited in a particular year, which is calculated by dividing the number of current citations to all articles published in the 2 previous years by the total number of countable articles published in those 2 years.

In the interview, Auberle, the study’s lead author, details how the program can fill gaps in current clinical trial development education standards during oncology fellowship, discusses notable data from the study, and looks toward am improved future of clinical trial development training for oncology fellows.

Oncology Fellows: What are the current shortcomings of education around clinical trial development during oncology fellowship?

Auberle: There could be a more structured approach. There are workshops for fellows, but they’re quite competitive, and a limited number of fellows can participate. [Even if] a fellow will be going to private practice, it is important to understand where the data for standard regimens come from. [I believe] a more structured and standardized approach for all fellows could help us all.

What does the clinical trial development program at Washington University School of Medicine in St. Louis look like, and what makes it unique?

[The clinical trial development program] was developed over 20 years ago, which is incredible. It started when our [oncology fellowship] program had just 50 faculty and approximately 5 fellows per class. [The faculty] saw this unmet need and decided to pair fellows with mentors to get hands-on experience in developing clinical trials. Over the years, the program has expanded, and we now have 9 fellows per class with over 150 faculty; 118 fellows have been through this program.

We’ve expanded to include a clinical trials boot camp lecture series, which has more specific lectures on [topics such as] each of the phases of clinical trials, trial development, and how to [make trials] diverse and inclusive. We also set up a timeline for our fellows in terms of [setting] a goal of when they would want to have their institutional review board approval and when they would want to start enrolling. Again, we’re giving more structure to the fellows in terms of goals they should meet.

The impact of the mentorship on this program is [also] key, and it’s that cycle that helps us get more fellows into academic positions. We have [clinicians] at our [institution] who have this [specific] expertise. Pairing them with [fellows] who are interested in staying in academic positions and getting [fellows] that exposure so they can learn the challenges of developing a clinical trial—thus [allowing] them to navigate those earlier—is truly powerful.

How did you conduct your study examining the program, and what were the key findings?

We [examined] 1 clinical trial per fellow, as we do have some fellows who have worked on multiple projects. [Disease types] were nearly evenly split between solid tumor oncology [n = 60] and classic and malignant hematology [n = 58].

[Overall], 79% of fellows received institutional review board approval [for their trials]. Additionally, 65% of those who received institutional review board approval went on to publication, with 45% of those [having] the fellow as the first author, which can be powerful for fellows looking to build careers in clinical trials. We [also examined] the [median] time from a fellow entering fellowship to getting institutional review board approval, and that was approximately 21 months, demonstrating it is possible to get a clinical trial started in the fellowship period. The [median] time to first enrollment for a clinical trial was 24 months.

On average, most fellows can get their trial open and enrolling within their first 2 years of fellowship. The last thing we [evaluated] was the odds of a fellow having their project approved by the institutional review board and then going on to an academic faculty placement. We saw an association with an odds ratio of 4.96 [95% CI, 1.54- 15.98; P = .007], which suggests that individuals who get their projects approved by the institutional review board have higher odds of getting an academic appointment.

What are the next steps for the clinical trial development program?

We would love to expand to other hematology and oncology programs. Within our institution, we’ve also talked about expanding to other fellowship programs within other divisions, [such as] infectious disease or rheumatology. In academic medicine, there is the potential to do clinical trials not just in hematology and oncology but other specialties…. Since we do so many, it would be helpful to share our expertise.

Reference

Auberle C, Wu N, Dipersio JF, Waqar SN, Ratner L. Integration of clinical trial development in hematology-oncology fellowship training. Acad Med. Published online May 30, 2024. doi:10.1097/ACM.0000000000005773