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Career Development LOI (CRDL) Program for Early-Career ETCTN Investigators

The Experimental Therapeutics Clinical Trials Network (ETCTN) Career Development LOI (CRDL) is intended to increase the success rate for LOI submissions from early-career investigators and to provide critical opportunities for investigators to develop and succeed in clinical research careers.

Becoming a principal investigator (PI) on a clinical trial is an important career development step for junior investigators; it permits the investigator to acquire experience in trial design and execution, it provides an opportunity to achieve recognition within the research community, and it provides credibility when applying for grant funding. Findings from NCI-supported early phase studies are presented at scientific meetings and are published in peer-reviewed journals, both of which are important for successful career advancement.

Key Components of the CRDL Program

Guidance from CTEP drug monitors

Since a successful outcome requires the submission of an approvable LOI, ETCTN CRDL investigators are encouraged to contact CTEP Investigational Drug Branch staff to obtain their input during LOI preparation. This approach should provide Early Career Investigators with a competitive advantage in the LOI submission process, while continuing to maintain the standards of the NCI/CTEP drug development program.

Incentives for institutions

By giving priority to LOIs led by early-career investigators, the CRDL program incentivizes institutions to make principal investigator roles available to junior faculty members. The program also requires institutions to provide CRDL investigators with an experienced mentor and ongoing research support, including research nurses, data management and statistical support, and access to patients.

Eligibility Requirements

In order to be eligible for consideration under the ETCTN CRDL program:

  1. The PI should have a major interest in clinical research and the intention to develop a career in that field.
  2. The PI should be within 10 years of completion of fellowship training and should be a faculty member at an institution with a successful track record in conducting cancer clinical trials.
  3. Fellows may not serve as PIs on studies.

CRDL Submission Process

The investigator should identify a senior faculty member who will serve as a mentor and provide expertise and oversight in the design and conduct of the trial.

Before submitting a Career Development LOI, contact the IDB Medical Officer(s) for the intended CTEP agent(s) to schedule a preliminary conference. The mentor and mentee must both participate in this conference. Career Development LOIs submitted without holding a preliminary conference will be refused. Please see the list of CTEP Agents and Active Agreements to identify the current IDB Monitors.

Your LOI submission should include the following required supporting documentation:

  1. Principal Investigator's curriculum vitae.
  2. Letter of commitment from the faculty mentor confirming the feasibility of the proposed trial within the institutional setting and indicating a commitment to enabling the PI to conduct clinical trial successfully.
  3. Letter of commitment from the institution indicating institutional support for the proposed study, including the availability of research nursing staff, data monitoring, and support from relevant departments/institution or groups to help conduct the proposed clinical trial.

Other Opportunities for Early-Career Investigators

Other resources available to Early-Career Investigators pursuing a clinical research career include the NIH's Mentored Patient-Oriented Research (POR) Career Development Award (K23) provides support for three to five years of supervised study and research for clinically-trained professionals who are committed to a career in patient-focused research.

Non-governmental opportunities include the American Society of Clinical Oncology (ASCO) Awards for career development and young investigators.

CTEP IDB Externships

The Investigational Drug Branch offers a no-cost externship program for medical or radiation oncology fellows or junior oncology faculty (<7 years from final oncology training) to shadow IDB medical officers, observe the trial development and review process, and receive one-on-one mentoring. This 4-8 week rotation is designed to provide participants with the skills to craft competitive LOIs and concepts and to communicate effectively with trial development stakeholders including patients, the research community, industry collaborators, and CTEP personnel.

The externship is located at the NCI campus in Shady Grove, Maryland. Participants are responsible for their own room and board. Space is limited to four participants per calendar month; contact IDB's Dr. Cheryl Pickett for registration information.

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