In FY23, the OCRP established a new academy, the Ovarian Cancer Clinical Trial Academy (OCCTA), which will focus on clinical trial research in ovarian cancer. The intent of the OCCTA is to enhance knowledge within next generation of Early-Career Investigators (ECIs) in clinical trial research and to produce effective treatments and cures for ovarian cancer. The OCCTA will bring together established investigators (the Academy Dean and Assistant Dean), established Career Guides (mentors), and a group of ECIs/Scholars to conduct successful, highly productive clinical trials in ovarian cancer. The OCCTA strives to develop successful, highly productive ovarian cancer clinical trialists in a collaborative research and career development environment, providing intensive mentoring, national networking, collaborations, and a peer group for junior clinical trialists. The OCCTA, through its Leadership, provides for professional and leadership development of the ECIs to include skills and competencies needed to execute clinical trials.
This FY24 program announcement is soliciting the first group of ECIs to join the new OCCTA. This Ovarian Cancer Clinical Trial Academy – Early-Career Investigator (OCCTA – ECI) Award mechanism enables the ECI (the investigator named as the Principal Investigator [PI] on the application) to pursue funding for ovarian cancer clinical trial research under the guidance of a Designated Mentor. Because of the early career nature of the PI, clinical trials initiated or collaborated with during the award period of performance are anticipated to be the led by the Designated Mentors. Beyond research, OCCTA ECIs will be expected to participate in monthly webinars and annual workshops and to communicate and collaborate with other members of the OCCTA (other ECIs, Mentors, Dean, Assistant Dean) as well as with the advocacy community.
Research funded under this FY24 program announcement will support translational research and small-scale, early-phase clinical trials in ovarian cancer. Examples of clinical trial focuses that are encouraged include but are not limited to diagnostic or prevention-focused studies, dietary or lifestyle interventions, therapeutic or surgical interventions, studies on quality of life, and repurposed drug trials. Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from the ovarian cancer research field.
Deadlines:
• Required Pre-Application (Letter of Intent) Submission Deadline: June 24, 2024
• Application Submission Deadline: August 6, 2024
Early-Career Investigator
o Must be within 12 years of last postdoctoral research position (Ph.D.), clinical fellowship (M.D.), or equivalent at the time of full application submission deadline.
A Statement of Eligibility is required with the submission of the full application.
For industry, investigators at or above an independent scientist level may be named by the company as the PI on the application, provided they meet the criteria listed above.
o Must commit no less than 25% effort to this award and/or OCCTA activities for the first 2 years.
o Individuals in a postdoctoral research position (Ph.D.), clinical fellowship (M.D.), or equivalent at the time of full application submission are not eligible.
o Investigators may apply to both Early-Career Investigator funding opportunities offered by the OCRP (i.e., the Ovarian Cancer Academy – Early-Career Investigator Award and OCCTA-ECI Award) during the same fiscal year but may not accept awards from both funding opportunities. Investigators may not participate in both the OCA and the OCCTA as an ECI at the same time.
Designated Mentor
o Must be an independent, established clinical trialist and have a balanced portfolio of successful clinical trial experience.
o Must have an active clinical trial at the time of application.
o May be at the same institution as the ECI. If not at the same institution, another Mentor (“Other Mentor,” see below) at the ECI’s institution must also be included in the application submission.
o Must have experience in ovarian cancer research if the ECI’s experience is not in ovarian cancer research.
o Must demonstrate a commitment to develop and sustain the ECI’s independent career in ovarian cancer research (it is recommended that the Designated Mentor demonstrate a 5% effort for mentoring and participating in OCCTA activities such as offsite meetings and webinars). Mentor responsibilities include mentoring the ECI (i.e., the PI of this award) and an additional ECI within the OCCTA. Offsite OCCTA activities include annual in-person workshops and monthly web-based meetings.
o A current OCA Designated Mentor can only be a Designated Mentor to one OCA-ECI or OCCTA-ECI; thus, current OCA Designated Mentors cannot be named as a Designated Mentor in an FY24 application unless the period of performance of the current OCA-ECI Award mechanism ends no later than July 2025. The current OCCTA Dean and/or Assistant Dean cannot be listed as a Designated Mentor.
Other Mentor (if applicable)
o Must be at the same institution as the ECI if the Designated Mentor is not from the same institution as the ECI.
o Must be an independent cancer clinical trialist or an independent researcher in ovarian cancer. The Designated Mentor or Other Mentor must have experience in ovarian cancer research if the ECI’s experience is not in ovarian cancer research.
o Must have research funding (past and present).
The anticipated direct costs budgeted for the entire period of performance for an FY24 OCRP OCCTA-ECI Award should not exceed $1.0M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.