Enrollment in phase 3 NCI Cancer Therapy Evaluation Program clinical trials designed for women with gynecologic cancers declined 90% from 2011 to 2016, according to the Society of Gynecologic Oncology.
The organization attributed this decline to NIH budget reduction and stagnation; restructuring of NCI–sponsored cooperative groups; and a shift in emphasis from clinical trials toward smaller biomarker-driven studies.
In conjunction with the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, the society issued a statement that outlined a five-point plan to address the crisis:
- Immediately increase funding for the NCI for clinical trials;
- Establish an annual summit with representatives of the Society of Gynecologic Oncology, NCI Cancer Therapy Evaluation Program (CTEP), advocacy groups and other stakeholders to develop partnerships with NCI–CTEP and NRG–Gynecologic Oncology Group leaders; align priorities for the gynecologic oncology scientific agenda; streamline infrastructure for review and approval of gynecologic cancer trials; and increase the number and availability of trials for patient access;
- Create a partnership at the National Center for Advancing Translational Sciences/NCI for the development of industry- and NCI–sponsored, investigator-initiated, multisite phase 1 and phase 2 clinical trials;
- Establish a clinical trialist career development program with NCI and CTEP, and develop grants for mentored research to increase investment in young investigators; and
- Make gynecologic cancers a priority in any NIH–supported biomarker development programs.
“Never before has medical science had such a wealth of knowledge in the areas of genetic determinants and molecular signatures that drive gynecologic tumor cell growth,” the society’s statement read. “Clinical trials hold the promise of translating this scientific knowledge into identification of actionable drugs, preventative strategies, enhanced patient outcomes and improved survival. We must chart a new course together to increase the availability of clinical trials for women’s cancers.”
To commence their efforts, members of the society planned to tweet at President Donald J. Trump this morning to call for increased funding for clinical trials in gynecologic cancers.