I want to share with you our understanding of the crisis in clinical trials in gynecologic oncology, and the steps the Society of Gynecologic Oncology is taking to address it. First, some background. In 2014, consolidation of the National Cancer Institute-funded cooperative groups into the National Clinical Trials Network (NCTN) resulted in the merger of the Gynecologic Oncology Group (GOG), Radiation Therapy Oncology Group (RTOG), and the National Surgical Adjuvant Breast and Bowel Project (NSABBP), forming a single entity, NRG Oncology. At the same time, NCI restructured its Clinical Therapy Evaluation Program (CTEP) protocol review process, shifting its emphasis to smaller biomarker-driven trials.
Overall accrual to all adult NCTN trials has declined by approximately 33% since cooperative group consolidation, with a disproportionate and alarming 82% reduction in accrual for gynecologic oncology clinical trials. The gynecology arm of NRG is effectively being downsized, marginalized and may become irrelevant within the NCTN mechanism. The current trend of clinical trial accrual through NRG Oncology is a major threat to the advancement of care for women with gynecologic malignancies.
What cannot be ignored or underestimated is the importance of the infrastructure that a busy and active multidisciplinary cooperative group provides for the design and conduct of clinical trials. The GOG, funded by NCI, provided that infrastructure for many years. Large Phase III trials rapidly accrued patients. The Developmental Therapeutics Committee was active with a robust menu of Phase I and II trials, and translational science and Quality of Life endpoints were attached to most of the Phase III trials. By 2011, 3,157 patients were accrued to therapeutic trials (including 2,370 to Phase III) and another 4,091 to non-therapeutic studies for that year. Tragically, the enrollment of patients with gynecologic malignancies to CTEP-funded clinical trials is now a small fraction of what it was in 2011.
Participation in clinical trials through the cooperative group mechanism has clearly been an integral component within the practice of gynecologic oncology and has provided significant advances in the care of women suffering from gynecologic malignancies. The SGO’s “Gynecologic Oncology 2015: State of the Subspecialty” report included data regarding SGO members’ interests and concerns related to clinical trials. The data revealed the following:
- 82% agreed that the SGO should advocate for increased clinical trial enrollment by its members.
- 86% participate in clinical trials. Gynecologic oncologists who are salaried and belong to large groups were more likely to participate in trials.
- Inadequate infrastructure was the leading barrier for participation in clinical trials. Insufficient time and funding were the #2 and #3 barriers.
- For those who participate in clinical trials, the leading barrier to enrolling more patients in trials was patient refusal, followed closely by lack of infrastructure, lack of time and inadequate funding.
- Gynecologic oncologists primarily participate in cooperative group studies, followed by industry-sponsored clinical trials.
- 48% of gynecologic oncologists indicated that the number of clinical trials they participate in has decreased.
- 45% indicated that changes in the NCI structure has led to downsizing in their clinical trial infrastructure.
Under the leadership and guidance of SGO’s Health Policy and Socio Economic Committee, SGO’s Legislative and Regulatory Taskforce is developing a multi-pronged approach to address this crisis in clinical trials. The SGO Congressional Ambassadors will advocate for an increase in funding, improved collaboration between NRG Oncology and NCI, and a more robust portfolio of innovative protocols to offer our patients. In this effort, we will strategize and collaborate with our patient advocates, associated societies and Washington-based advisor. We will be taking the following steps:
- Make NCI aware of the devastating effects that the decline in research funding has had on the loss of an important infrastructure, thus compromising access for patients to trials, development of the next generation of clinical investigators, and continued advancement in the therapies of these less common malignancies.
- Request an immediate increase in funding for NCI-supported clinical trials in gynecologic oncology.
- While there has been an overall reduction in accrual throughout the NCTN, support for gynecologic oncology should be in line with the overall reduction of the NCTN group.
- Be allowed to work with NCI to identify the human and capital resources necessary to maintain the clinical and scientific centralized infrastructure needed to guide advances in therapy for these relatively low incidence diseases.
- Within the construct of the NCTN, we will request that CTEP:
- Give NRG Oncology’s gynecologic oncology experts more control and more seats at the table regarding development and prioritization of the gynecologic oncology scientific agenda.
- Partner with NRG Oncology to develop science-driven standard of care defining Phase III trials in gynecologic malignancies.
- Increase the portfolio of science-driven novel therapies for women with gynecologic malignancies, especially in those with the highest mortality.
- Partner with NRG Oncology to sponsor Clinical Trial Planning Meetings for trial development.
- Reinitiate innovative clinical trials in patients with recurrent disease where the prevalence of disease burden over an extended period of time is significant.
- Create a multidisciplinary and collaborative decision-making process for gynecologic oncology clinical trial efforts within the CTEP and NCTN.
The taskforce is also developing a plan for grassroots lobbying of key leaders in Congress during Gynecologic Oncology Awareness Month (GCAM). More information on what you can do to help is coming soon. SGO recognizes the extent of this crisis. We want to leverage our resources to resolve it. I welcome your suggestions for additional strategies at Jeffrey.Fowler@sgo.org. The time for action is now.
Jeffrey M. Fowler, MD