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The SGO BRIDGES Research Initiative is a new, longitudinal clinical trials workshop for early career investigators with the aim of developing the next generation of trialists who will lead investigator-initiated and cooperative group gynecologic cancer clinical studies. It is designed to bridge the gap between translational scientists and clinical trialists in gynecologic oncology by providing formal training for early-career investigators in clinical trial design, connecting participants with expert mentors, and supporting the development of novel clinical trials.

Accepted early-career investigators will be part of an exclusive cohort and participate in a comprehensive workshop led by expert faculty. This is a unique opportunity to learn advanced skills in clinical trial design, develop professional connections, kickstart an academic career, and impact the future of gynecologic oncology research and treatment.

The course will begin in January 2023 and will admit a small cohort of early-career investigators. Programming will include in-person symposia, twice-monthly Zoom didactics with course faculty, and small-group trial development sessions where participants will

  • meet with expert mentors and peers
  • identify unmet clinical needs in gynecologic oncology and design novel clinical trials
  • develop strategies to integrate correlative translational studies with clinical protocols
  • develop a clinical trial design of their own.

Proposals must be new and original. Protocols already in development will not be accepted, and Phase III concepts are discouraged.

Applications are due on Nov. 28, 2022. In the meantime, all prospective participants are encouraged to begin collecting their application materials and seeking the required Letter of Support from their program directors or division/department heads.

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What is the SGO BRIDGES Research Initiative?

  • A comprehensive, longitudinal scientific program that integrates in-person symposia at SGO And NRG Oncology meetings, twice-monthly zoom didactic sessions, and small-group protocol development sessions. 
  • A unique opportunity to network and be mentored by  oncology faculty with expertise in clinical trials, biostatistics, molecular biology, immunology, and genomics. 
  • An exceptional educational experience utilizing various approaches in a setting conducive to building professional relationships and research collaborations. 
  • An opportunity to achieve significant deliverables (stated in the section above) that will boost careers and jump-start clinical trials. 

Curriculum

  • Block 1: Defining critical questions and research priorities in gynecologic oncology
  • Block 2: Building a foundation – preclinical studies and phase I trials
  • Block 3: Phase I to Phase II – Defining a cohort and endpoints
  • Block 4: Novel trial designs
  • Block 5: Phase III trials
  • Block 6: Patient reported outcomes
  • Block 7: Surgical trials
  • Block 8: Prevention trials
  • Block 9: Nuts and bolts of study initiation
  • Block 10: Funding opportunities and sponsorship

Participants will be announced Dec. 15. The program kicks off in January 2023 in Orlando, FL.

DOWNLOAD THE PROGRAM TIMELINE

Application Summary

The online application procedure requires the following items:

  • A description of the clinical trial you intend to develop during the SGO BRIDGES Research Initiative program (limit three pages). This should include the following:
    • Background emphasizing the rationale and preclinical data (if relevant) informing the proposed study, the specific hypothesis to be addressed, and the primary endpoint.
    • A statement of the feasibility of the proposed protocol, including a discussion of possible pitfalls/challenges to study implementation and alternate approaches.
    • A brief description of proposed correlative or translational studies to include in the protocol (biomarker discovery, mechanistic validation, target engagement, pre-/post-treatment sample analyses)
  • Your C.V. or NIH Biosketch
  • A personal statement explaining why you wish to participate in the SGO BRIDGES Research Initiative program (limit 500 words).
  • A Letter of Support from your Program Supervisor or Division/Department Head confirming that you will have protected time to participate in the SGO BRIDGES Research Initiative program.

Detailed instructions are found below. Applications will not be accepted unless they contain all the elements described above. All parts of the application form, including the Letter of Support, must be submitted before the deadline.

Eligibility

  • The SGO BRIDGES Research Initiative is intended for gynecologic oncologists, medical oncologists or radiation oncologists in the early stages of their careers.
  • Both fellows (with a substantive research background) and early-career faculty will be considered (i.e., <10 years since graduation from fellowship)
  • Fellows and faculty must have one of the following degrees: MD, DO or MD/PhD
  • Applicants must be familiar with the basic concepts and techniques of statistics and study design. Eligible fellows must have completed course or degree work in biostatistics. Course work in clinical trials is not mandatory but will enhance the application.
  • Applicants must be in or plan to enter a career track that will permit them to serve as a principal investigator on a clinical trial.
  • Participants must be SGO members. Applicants may  apply for SGO membership at time of application.

Application Instructions

Application submissions will only be accepted electronically; paper applications will not be accepted. To submit an application, you must have all four of your application items ready to upload (see list above).  

More details about the application process are outlined below: 

 

1. Clinical trial description/Letter of Intent:

Submit a description (limit three pages) of the clinical trial protocol you intend to develop. This program seeks trials and intervention studies that can be completed in a reasonable time by an individual with available resources. This must be a new and original proposal. Protocols that are already in development will not be accepted, and Phase III concepts are discouraged.
 
The description should follow the format below and include the following components:  

  • Title
  • Investigators (PI, Co-PI, Translational Science PI, Statistician)
  • Background and rationale
  • Primary hypothesis
  • Primary and secondary objectives
  • Brief description of study design and analysis plans
  • Planned correlative or translational studies with the associated rationale, hypothesis and planned endpoints
  • Feasibility statement
  • Please note whether you currently have access or an agreement to use the drug(s) proposed in your study, if relevant. If yes, please include appropriate documentation from the pharmaceutical supplier. This is not a requirement for program participation.
  • Estimate the number of potentially eligible patients at your institution (or the eligible patients within a multisite or cooperative group trial) that would support the feasibility of your study
  • Estimate how long you expect it will take to complete your study.

2. C.V.:

  • Please upload a PDF copy your C.V. or NIH Biosketch to the application portal

 

3. Personal Statement

Provide statement (one page) explaining why you wish to participate in the SGO BRIDGES Research Initiative. Be sure that your statement provides the following information: 

  • A description of your previous research background and academic goals in the next 5 years.
  • An explanation of how participation in the program will help you to design and conduct the trial outlined in your protocol as well as your career. 
  • A commitment to participate in the long-term evaluation of the SGO BRIDGES Research Initiative program by maintaining contact with organizers and responding to questionnaires when requested.

4. Letter of Support

Before you begin your application, you must obtain a Letter of Support, with institution heading and in a PDF format.

  • Only one Letter of Support is accepted per applicant. If you are between positions, please choose either your current or future supervisor to submit this letter.
  • The author should provide a statement of support for the applicant to participate fully within the SGO BRIDGES Research Initiative program and for the applicant to develop the proposed trial concept. 
  • Without a Letter of Support and submitted application, your application will be INCOMPLETE and WILL NOT BE CONSIDERED.