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Building Critical Skills and Mentorship in Clinical Research: Insights from the ASH CRTI

November 1, 2024

November 2024

The American Society of Hematology’s (ASH) Clinical Research Training Institute (CRTI) is a year-long education and mentoring program for hematology fellows and junior faculty at academic medical centers. The CRTI offers a broad education on clinical research methods, research collaborations, and statistical analysis, in addition to guidance on career development and work-life balance. The program’s goal is to produce leaders armed with ideas for clinical hematology research and the tools and resources to make their ideas a reality.

This month, ASH Clinical News caught up with Seda Tolu, MD, assistant professor of medicine at Columbia University in New York, to dis­­cuss her experience so far in the 2024 CRTI, which kicked off in August with a week-long workshop in La Jolla, California.

Seda Tolu, MD

Seda Tolu, MD

What interested you about the CRTI and ultimately led you to decide to participate?

I’ve always been someone who’s very translational, and I wanted to be an early-phase clinical investigator but with laboratory expertise. I already had considerable lab experience before the CRTI, but I was lacking the experience in clinical trial design and how to plan a trial, how to execute it, how to budget, and how to perform the statistics. That’s all very different from what I was doing in the lab for the past three years, and I wanted to take the abundant experience I’ve cultivated in the lab and learn how to best apply it in a clinical trial setting. My goal was always to apply to the CRTI as I developed my lab skills during fellowship. I applied during my third year of fellowship, and I was really glad I was selected to participate.

The research project is a big component of the CRTI. Can you share more about the project you’ve developed?

I developed a phase II multicenter trial of ruxolitinib and pembrolizumab for patients with relapsed or refractory Hodgkin and non-Hodgkin lymphoma. That concept was brought to fruition from the preclinical work I generated in fellowship demonstrating that ruxolitinib and pembrolizumab work synergistically to enhance immunogenicity and T-cell mediated killing of 9p-amplified lymphoma cells. With my mentors at Columbia, we developed this trial, and I took it to CRTI, fine-tuned it, and made critical changes to it. Now, we’re rewriting the protocol to finalize the trial, and we hope to have that final trial open in spring 2025.

I think this trial will be pivotal for me; I’m a junior faculty, so the next few years in my career are really important in terms of what I make of it. Having a strong trial that provides novel data, from both the clinical standpoint and the correlative standpoint, will be incredibly significant. This will create multiple opportunities for future trials and grant funding, and, most importantly, help change the treatment paradigm for patients suffering from lymphoma, which is always the end goal in everything we do.

Who have been your mentors thus far, both at your institution and through the CRTI, and what has it been like working with them?

At Columbia, my mentors are Jennifer Amengual, MD, and Barbara Pro, MD, which has been phenomenal as I have support from both the laboratory and clinical trial perspectives. At the CRTI, I was introduced to amazing extramural mentorship. My team of mentors included Laurie Sehn, MD, MPH; Greg Nowakowski, MD; Jason Westin, MD, MS; and Matt Maurer, DMSc, MS. Dr. Amengual was also one of the CRTI mentors. Each one of these mentors provided invaluable advice and insights that I am so grateful for.

The CRTI doesn’t just teach you how to write or design a clinical trial; it gives you the tools to be successful in every aspect of your career.

Dr. Westin is my longitudinal mentor, and we have monthly mentorship meetings. It’s been wonderful to discuss the questions we’ve cultivated at CRTI, and he can help guide me toward my short- and long-term goals. He has years of experience and unique expertise in clinical trial design, so it’s been helpful to get his outside perspective on ways to improve my current projects and the future steps that will follow — all of which will be crucial to my professional development.

Dr. Maurer was another mentor who I collaborated closely with. As clinical or translational investigators, we don’t just work on one project — we have many different projects going at the same time in different phases of development. Working with Dr. Maurer, I learned so much about statistics from him, but then I also was able to develop another one of my retrospective studies and strengthen the dataset and design. These are just a few examples, but the networking and mentorship I gained from the CRTI was so important, not just for that one idea I came to CRTI with, but for every aspect of my career.

Did any of them share any advice or wisdom that has particularly stuck with you?

There are so many. One thing that co-director Wendy Stock, MD, said is, “Your life is short, but your career is long.” That was helpful to put things into perspective because as junior faculty and fellows, we’re all very early in our careers. Our field is moving so fast, and as we look ahead five to 10 years, it can all feel very daunting. Having the perspective of these leaders in the field helps ground you and gives you affirmation that these goals are possible — and that you are part of a community of amazing physicians who are going to help you reach them.

What advice would you give prospective participants?

Don’t be shy to apply — it rhymes! The work you put into the application pays you back a million times over because it was definitely a worthwhile experience.

If you have an idea that needs sharpening, work with your mentors at your institution to cultivate that idea as much as possible so you can apply to this program and develop it further. The CRTI doesn’t just teach you how to write or design a clinical trial; it gives you the tools to be successful in every aspect of your career. I would encourage every fellow and junior faculty to apply because this was one of the most meaningful mentorship programs for this stage of my career.

Is there anything else you want people to know about the CRTI?

Outside of the amazing mentorship, you also make great friends, and that’s so important, because as you go on in your career, your field gets smaller and smaller, and it’s nice to know who those people are. The environment at CRTI is so warm and allows you to make amazing friends who you can talk to about hematology and also life. These friends will also be your future collaborators and colleagues, so these become incredibly valuable relationships. I made some lifelong friends from the CRTI, and I can’t wait to see them at the ASH annual meeting in December.

The application cycle for the 2025 program is now open, with letters of interest (LOI) due January 9, 2025. For more information, including how to submit an LOI visit hematology.org/awards/career-enhancement-and-training/clinical-research-training-institute.

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