One of my priorities as president of the Society of Gynecologic Oncology (SGO) is to mobilize the considerable resources of the organization to address the crisis in gynecologic cancer clinical trial access.
For a variety of reasons, enrollment in gynecologic cancer trials has plummeted in recent years. Ironically, The New York Times reports that breakthroughs in immunotherapy are generating “A Cancer Conundrum: Too Many Drug Trials, Too Few Patients.”
At the 2017 Annual Meeting on Women’s Cancer in National Harbor, MD, we conducted a summit with representatives of SGO, advocacy groups, the National Cancer Institute (NCI), NRG Oncology and GOG Foundation to identify priorities for the gynecologic oncology scientific agenda, streamline an infrastructure for the review and approval of trials, and increase the number and availability of trials for patient access. We also convened for the first time a group of 100 invited young investigators at NCI headquarters in Bethesda, MD, to provide an overview and introduction to the world of gynecologic cancer clinical trials.
Under the leadership of Saketh Guntupalli, MD, of the University of Colorado School of Medicine, SGO has committed to enrich the training of this cohort of young investigators, who will reconvene March 23, 2018, before the Annual Meeting on Women’s Cancer in New Orleans for the second step in a new four-year curriculum.
In establishing a renewable program for young investigators, we aim to improve the lives of women with gynecologic cancers through improvements in early detection, targeted therapies, and quality of life in survivorship.
Each year beginning in 2019, trainees enrolled in or within seven years of successful completion of an Accreditation Council for Graduate Medical Education (ACGME)-accredited gynecologic oncology fellowship program will be selected to participate in the four-year curriculum.
The group will spend one day together each year on the day prior to the Annual Meeting on Women’s Cancer. The program will include a mixture of didactic and breakout sessions dictated by the topics that year. Every other year, a portion of the sessions will focus on grant writing and funding opportunities particularly as they relate to young investigators interested in clinical trials. The breakout sessions will include small group activities and/or one-on-one time with experienced investigators.
The full curriculum for the first cohort of investigators has been established and will serve as a guide for future cohorts.
Year 1 (2017 – Bethesda, MD): Overview and structure of the NCI, current controversies in gyn cancers, pearls to obtaining federal funding, overview of statistical methods and designs, clinical trial advocacy
Year 2 (2018 – New Orleans, LA): Phase 1 and 2 trial design and concepts, novel trial designs, selection of trial endpoints, participation in NRG committees, pathway to NRG concept submissions, clinical trial advocacy
Year 3 (2019 – Honolulu, HI): Pharmacologic basis for targeted and molecular therapies, incorporating bio-marker correlates into trial design, inclusion of underrepresented persons of color and other special populations in clinical trials, inclusion of patient-reported outcomes and quality of life metrics, writing grants to score well, clinical trial advocacy
Year 4 (2020 – Toronto, ON, Canada): How to give research presentations, clinical trial ethics, navigating the regulatory landscape, early career development awards and opportunities, clinical research informatics, clinical trial advocacy
A measure of success for each participating investigator will be the activation of a clinical trial developed, refined or amended under the auspices of this program.
Establishing, training and building a pipeline of proficient investigators is mission critical to addressing crisis in gynecologic cancer clinical trials. Increasing public awareness and education is also critical. September is Gynecologic Cancer Awareness Month. Follow the Foundation for Women’s Cancer on social media and share the messages, using the hashtags #endwomenscancer and #Trials4GynCancerNow.
We have a long way to go, but when it comes to turning the tide on clinical trials, SGO is one determined honey badger.
Laurel W. Rice, MD