Over the years, clinical trials have been the strongest means of advancing cancer research and treatments. Clinical trials are pivotal to developing novel therapeutics to enhance the anticancer drug arsenal. Most patients with cancer do not participate in clinical trials, even though nearly three-fourths of Americans are said to be interested in or willing to enroll in clinical trials.

 This discrepancy is partially explained by clinicians’ unawareness of opportunities to enroll patients in ongoing clinical studies. Moreover, many early-career clinicians are not familiarized with clinical trials during their training, given that this is not part of their hematology-oncology fellowship. Thus, the opportunity to educate future trialists is hindered.

Not surprisingly, these barriers are heightened for patients and clinicians from underserved racial or ethnic populations, low educational and socioeconomic levels, and/or those residing in rural areas. Many strategies to tackle these obstacles have been widely discussed in the literature; however, policies formally incorporated into graduate medical education curricula are missing. Increasing awareness is often recommended through education during fellowship programs; however, across the US, just a few institutions have properly included clinical trial training to prepare future oncology trialists.

 Moreover, why these recommendations have not been adopted nationwide is unclear. Although not all clinicians will become trialists, it is important that they are aware of clinical trial opportunities to expand recruitment, contribute to research with fairness, and promote engagement.

Other strategies at the provider level aim to promote clinical trial enrollment during patient-physician encounters. However, engagement will likely decrease if the programs provide no formal training. Desirable features in clinical trial curricula train clinicians in a multidisciplinary environment where communication specialists, experienced trialists, clinical research coordinators, and mid-career/senior oncologists are actively involved.

Moreover, efforts should be focused on providing additional resources and maintaining engagement in underrepresented populations. These populations are more likely to have higher dropout rates, which can affect equity in clinical trial enrollment.

An anticipated outcome of early-career clinicians receiving education and training in clinical trials is that they will likely develop research skills centered on the patient. Moreover, when clinicians offer to enroll patients in clinical trials, this increases access to novel treatments with the promise of safer and/or higher effectiveness compared with the standard of care; thus, patients receiving novel therapies or treatment modalities may have access to potentially lifesaving therapies or increasing their quality of life, which are pillars in cancer care. The earlier an oncology fellow receives appropriate training, the more efficiently they will be able to manage patient recruitment, consent, and ethical considerations, which will ultimately enhance patient care, and advance clinical research in their institutions or centers. Ethical and science advisory boards are also more likely to benefit from medical discussions under ethical principles, ensuring clinical research is conducted with the highest standards and integrity.

Another advantage of educating clinicians early in their careers is to aid in identifying and promoting equity in accessibility to clinical trials. Inclusiveness can be promoted if clinicians know about a patient’s disparities. Thus, by acknowledging barriers such as fear of adverse effects, the clinician can become an advocate and ally to increase accessibility with fairness and justice. In subsequent patient encounters, these interactions are likely to strengthen the patient-physician relationship, with valuable results for clinical care and research.

Overall, a comprehensive education curriculum during hematology and oncology fellowship for clinical trials will yield individual and societal benefits by advancing cancer treatment, improving patient-relevant outcomes, and enhancing cancer research.

Ivy Riano, MD, is a thoracic oncologist and an assistant professor of medicine at Dartmouth Cancer Center, Dartmouth Hitchcock Medical Center, and Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

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Articles

Many early-career clinicians are not familiarized with clinical trials during their training, so the opportunity to educate future trialists is hindered.

Clinical Trial Education Is Essential in Hematology and Oncology Fellowship Curricula

I first became acquainted with the African proverb, “If you want to go fast, go alone. If you want to go far, go together,” during the most clinically challenging year of my graduate medical education: PGY-4, or the first year of a hematology/medical oncology fellowship. During simultaneous learning of the basics of chemotherapy and fighting off yet another wave of COVID-19, I also sought mentors in hematology and oncology to guide the development of my research pursuits. Luckily, I matched with 3 superior mentors and sponsors during my fellowship; however, this is not the case for every trainee. According to a survey of oncology trainees and early-career faculty (n = 306), respondents who were underrepresented in medicine (n = 64) were less likely to have a primary mentor compared with those who were not underrepresented in medicine (n = 242), at 66% vs 80%, respectively (P = .015).

 Now that I have completed my fellowship, I hope to share my reflections on the benefits, challenges, and critical elements of effective mentorship in hematology/oncology.

Although many benefits of mentorship have been reviewed, such as transitioning through traditional paths into academic practice, private practice, or drug development, the intangible products of mentorship are equally, if not more, valuable.

 Trainees must balance competing demands during hematology/oncology fellowship, varying from knowledge streams that consistently change to intricacies in patient populations and clinical trial design. It is often the mentor to whom a trainee turns for guidance when our field’s algorithmic recommendations cannot be routinely followed. For example, one mentor/ sponsor’s real-world experiences in various clinical settings, including academic, hybrid, and private practice, yielded invaluable insights that cannot be found online or through formal recruitment avenues. Without her guidance, my job search would have been much more complex.

Despite the various tangible benefits of mentorship, some challenges are also worth noting. Time is by far the most limiting factor. However, other difficulties may weigh into any mentor-mentee relationship, such as overcommitting, ghosting, and even backstabbing on the mentee’s part.

 Some strategies that might overcome these missteps include clearly stating one’s career goals, embracing failure as an inevitable part of growth, and remaining open to longitudinal feedback.

 Additionally, mentees might not only rely on a single mentor to propel their success but obtain multiple connections that serve various roles, including professional coaches, sponsors, and connectors.

 Looking outside one’s institution also yields multiplicative benefits for networking and connecting.

Mentoring and mentorship strategies will vary based on the mentor-mentee dyad. Throughout my fellowship, I have found the following methods particularly helpful:

Hematology and oncology are busy in terms of the complexity of patients seen and the emotional intensity required to practice. It is imperative that any trainee seeking mentorship or other career advice schedule such conversations well in advance. One of my mentors and sponsors serves in numerous institutional, national, and international roles, necessitating his constant availability outside working hours. We ensured adequate face-to-face time by scheduling bimonthly check-in meetings before deadlines and other pressing issues.

2. Show Up (to Clinic, Didactics, Conferences)

As the saying goes, half of life is about showing up. The hematology/oncology fellowship is a particularly challenging training period due to the lack of many of the fields’ subspecialty concepts being taught in medical school or residency. Although the clinical demands of fellowship can be trying, it is important to prioritize yourself and your career success by being present for as many educational and networking opportunities as time (and stress) permit. By attending various diseasefocused clinics, nearly every didactic session offered by my fellowship, and local, national, and international conferences, I have been fortunate to meet multiple mentors and sponsors among general and disease-specific oncology organizations. These individuals remain precious to me personally and my career growth.

3. Promote Those in Earlier Stages Than Yourself

Fellows must remember that, despite their own need for mentorship, they too can serve as mentors and sponsors for trainees in earlier stages than themselves. Indeed, elements of the “hidden curriculum” demonstrated by fellows often have downstream effects that manifest later in the careers of other trainees.

 During my chief fellowship year, I helped formalize a disease-focused working group that produced several research initiatives and served as a safe space within the complex graduate medical education network to discuss concerns, anxieties, and other pieces of advice. This community continues to be bolstered to this day, and I am both proud and nostalgic as I leave it behind.

Ralph Waldo Emerson defined success as leaving “the world a bit better” and this maxim applies to both mentors and mentees. Whether demonstrating this example in the clinic with patients or on rounds with mentees, the hematology/oncology clinician must leave a lasting example for those around them. Indeed, many of us (me included) naturally gravitate to these types of practitioners, launching us toward the hematology/ oncology training journey. As my training ends, I hope we all pledge to leave the best lasting examples we can.

Samuel A. Kareff, MD, MPH, is a medical oncologist and hematololgist at Baptist Health in Boca Raton, Florida. He was formerly the outgoing chief fellow of hematology and medical oncology at the University of Miami Sylvester Comprehensive Cancer Center/Jackson Memorial Hospital in Miami, Florida. 

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Mentorship in hematology/oncology is crucial for navigating the complexities of the field, offering both tangible and intangible benefits. Effective mentorship can guide trainees through career transitions and provide invaluable real-world insights. However, challenges such as time constraints and potential missteps in mentor-mentee relationships exist. Strategies for successful mentorship include setting regular meetings, attending educational events, and fostering a supportive community. Mentors and mentees should aim to leave a lasting positive impact, promoting growth and success for themselves and others in the field.

Samuel A. Kareff, MD, MPH, shares his reflections on the benefits, challenges, and critical elements of effective mentorship in hematology/oncology.

The Importance of Hematology/Medical Oncology Fellowship

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 

. “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 

, 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.

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

: 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.

Auberle C, Wu N, Dipersio JF, Waqar SN, Ratner L. Integration of clinical trial development in hematology-oncology fellowship training. 

. Published online May 30, 2024. doi:10.1097/ACM.0000000000005773

Washington University School of Medicine in St. Louis has developed a clinical trial development program for oncology fellows to address the lack of standardized training in this area. The program, initiated in 2002, pairs fellows with mentors to gain hands-on experience in clinical trial design and execution. A retrospective analysis showed that 60 of 118 fellows published their studies, with a significant portion achieving first authorship. The program aims to expand to other specialties and institutions, enhancing clinical trial education and potentially increasing academic career placements for fellows.

Faculty at Washington University School of Medicine in St. Louis have designed a clinical trial development fellowship education program.

Optimizing Training for Future Clinical Trial Investigators

In this issue, I want to highlight a recent landmark decision by the FDA concerning trial design moving forward for cancer drugs. For over 100 years, the FDA has worked to ensure the safety and efficacy of human and veterinary medicines, biologics, and medical devices.

In particular, the Oncology Center of Excellence within the FDA was established in 2017 as authorized by the 21st Century Cures Act. The FDA’s Oncologic Drugs Advisory Committee (ODAC), comprising 13 voting members, evaluates data concerning the safety and efficacy of marketed and investigational human drug products for the treatment of patients with cancer. ODAC then makes a recommendation to the FDA commissioner.

The approval process is much more complex than it seems. I bring your attention to this process due to a recent landmark decision by ODAC and the FDA concerning the phase 3 AEGEAN trial (NCT03800134). On July 25, 2024, the FDA reviewed data from this trial, which evaluated perioperative and postoperative durvalumab (Imfinzi) for patients with stage IIa to IIIb non–small cell lung cancer without known targetable mutations or translocations. The randomized, placebo-controlled trial enrolled 740 patients using intention-to-treat rules (

By traditional standards, the completed trial was successful and demonstrated significant and clinically meaningful improvement in event-free survival (EFS). However, the FDA flagged this trial for review by ODAC in July 2024. Although the FDA did not question the EFS benefit, the critique concerned the study design, which did not separate the role of neoadjuvant vs adjuvant durvalumab in attaining the EFS. In other words, are both exposures necessary? Are we subjecting patients to higher costs and risks of toxicity?

The FDA has now required that 2-arm trial designs specifically address this issue. That means instead of 1 trial with 2 arms, this will necessitate either separate trials or a 3- or 4-arm trial design. It is anticipated that this decision may require more patients, more investment by drug companies, and more time to answer these clinical ques - tions. This may be a win for patient safety and financial toxicity. It may slow drug discovery and approval and thus slow progress for our patients. Time will tell.

Even if clinical trial design is not a primary topic of interest, it is important to recognize how design is incredibly important and must be considered when interpreting data. We live in a world of clinical trials. Small shifts in paradigms can greatly affect our patients and science.

On a related note, I strongly encourage any fellow to apply for the FDA-ASCO (American Society of Clinical Oncology) Hematology and Oncology Fellows Day Workshop. This in-person workshop occurs annually at FDA headquarters in Silver Spring, Maryland. Workshop participants are immersed in an informative deep dive into the complex steps of getting a drug from concept to trial and approval. The workshop is highly educational, and participants quickly realize that the people who work for and with the FDA have a true passion for patient safety and impactful drug discovery. 

Durvalumab with platinum-containing chemotherapy as neoadjuvant treatment followed by single-agent durvalumab as adjuvant therapy was approved by the FDA for patients with resectable non– small cell lung cancer with no known EGFR mutations or ALK rearrangements on August 15, 2024.

FDA YouTube page. July 25, 2024, meeting of the Oncologic Drugs Advisory Committee. https://www.youtube.com/live/smUHtK5wdic

The FDA's recent decision on cancer drug trial design emphasizes the need for more precise evaluation of neoadjuvant versus adjuvant therapies. The phase 3 AEGEAN trial, which assessed durvalumab for non-small cell lung cancer, highlighted this issue. Although the trial showed significant event-free survival benefits, the FDA questioned the study design's ability to differentiate the effects of neoadjuvant and adjuvant treatments. Consequently, the FDA now mandates more complex trial designs, potentially increasing patient safety but also requiring more resources and time, potentially slowing drug development.

Jill Gilbert, MD, highlights a recent landmark decision by the FDA concerning trial design moving forward for cancer drugs. 

Vol. 16 Issue 3 | Oncology Fellows

Clinical Trial Education Is Essential in Hematology and Oncology Fellowship Curricula

The Importance of Hematology/Medical Oncology Fellowship

Optimizing Training for Future Clinical Trial Investigators

The New Era of Clinical Trial Design