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 T32 Laboratory Based Investigator Training

 

Program Description

The T32 award is a training grant funded by the National Institutes of Health (NIH) designed to foster the careers of investigators interested in oncology/cancer-related basic laboratory research. T32 award recipients are required to spend at least 24 months continuously in the laboratory, devoting at least 40 hours per week to laboratory research training. The grant currently has 8 slots. The award is generally for 2 years but an annual application is required to document progress in the previous year.

Who can apply?

The award is for any postdoctoral US citizen or green card holder that is doing basic research that is cancer-related. The T32 award requires that the participating post-doctoral fellow devote a full 24 months to laboratory research. T32 awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program.  Within the 40 hours per week training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

In order to comply with this requirement, Hematology/Oncology fellows who elect to participate in the T32 program must participate in the Medical Oncology Fellowship tract, which is a 2-year program with 12 months of clinical training and 12 months of protected research time. In order to complete the ABIM requirements for Oncology Board eligibility and stay in compliance with the T32 training program, the first year of medical oncology fellowship includes the required 12 months of clinical training, and their second year of fellowship training includes 12 months of protected research time during which T32 training may start. During the 12 months of protected research time, in order to meet requirements for board eligibility in Medical Oncology, the fellows must continue to attend and participate in all required conferences (Clinical Case Conference, Basic Lecture Series, Journal Club, Tumor Board, and Cancer Center Ground Rounds) and continue to attend a weekly ½ day continuity clinic. By the end of the second year of training, the fellow will have officially completed all of his requirements for Medical Oncology Board eligibility and will have completed the Medical Oncology Fellowship. He/she will continue to train as a post-doctoral fellow in the T32 program, but will not be required to attend Hematology/Oncology Fellowship conferences or continuity clinic.

Application process

New applications for the T32 award in oncology (post-doc stipends) are typically solicited in March or April of each year. An announcement from Dr. Caligiuri’s office is released every year in March or April detailing the application process, the deadline for submission, and the award date. Applications are generally due in late April or early May, usually 3 weeks after the announcement is released. Candidates must submit an original application and 10 copies to Tamra Brooks, A458 Starling-Loving Hall, 320 West 10th Avenue, Columbus, Ohio 43210; it is imperative that the grant application, three letters of recommendation, and preceptor’s CV be received by the deadline. The selection committee meets in early May to select the new trainees.

T32 awardees who have received one year of funding and are interested in continuing their funding for another year of support need to re-apply. This re-application should document progress, in the form of experiments, talks, publications and will only require a follow-up letter from your primary mentor. First year T32 awardees are likely to be funded for a second year with reasonable amount of progress. In certain situations, T32 awardees who have completed 2-years of laboratory training, may apply for a third year of T32 support, but these second year T32 awardees will be competing more closely with new applicants.

Ohio State Comprehensive Cancer Center Clinical Investigator Research

Program Description

The OSU CCC Clinical Investigator Research Pathway is designed for medical oncology and hematology/oncology fellows who desire training and experience in clinical research with an emphasis on early antineoplastic drug development methodology, with particular focus on phase I and II clinical trial design and implementation.  The training program encompasses clinical aspects of new oncology drug development including pharmacology, trial design, statistics, regulatory issues, and translational laboratory projects.  It is expected that oncology fellows will enter into the Clinical Investigator Research Pathway 12-18 months into the fellowship program.

An NCI-sponsored Phase I Research Consortium (P1RC), with Dr. Michael Grever as principal investigator, is in operation and brings exciting new agents from the laboratory into the clinic. A NCI-sponsored Phase II Research consortium (P2RC), with Dr. Miguel Villalona as principal investigato, provides all trainees with the opportunity to study new cancer drugs in protocols, which correlate clinical outcomes with biologic measurements. Because the P2RC involves community hospitals working together with Ohio State, trainees who wish to participate in this clinical research effort interact with community oncologists engaged in state-of-the-art research with the training faculty. The P1RC and P2RC provides the fellows interested in clinical and laboratory research access to novel agents to design clinical studies and in vitro trials, and national recognition and collaboration with NCI-investigators.

Goals

  1. To provide specialized training and experience in the design and conduct of clinical studies of emerging oncology drugs.  It is anticipated the Clinical Investigator Research fellow will submit at least two letters of intent and write at least one clinical research protocol in its entirety.
  2. To provide clinical experience in the management of patients participating in oncology drug development trials. It is anticipated that fellows will consent, enroll, and follow patients on clinical trials relevant to their subspecialty area of interest (i.e. benign hematology, lymphoma, leukemia, breast, lung, gastrointestinal tumors, etc.). Fellows will be expected to attend clinic at least 2 half-days/week and participate in weekly toxicity meetings between the principal investigator, research nurses, and data managers.
  3. To provide specialized training in statistics required for clinical trial design.
  4. To provide specialized training in the design and interpretation of ancillary laboratory studies utilized in the oncology drug development process including pharmacokinetic, pharmacogenetic, and pharmacodynamic studies.
  5. To promote an understanding of pharmaceutical industry and government drug development issues.

Supervision and Mentorship

Each fellow will choose physician faculty mentor based on their subspecialty interest, who will provide guidance for the completion of the required projects detailed below. This mentor should have an interest in clinical research and be an active participant in the Phase I/II programs at the Ohio State University.  The fellowship Program Director will monitor individual performance and handle any disciplinary issues.  Supervision for specific program components will be provided by appropriate faculty depending on the activity and requirements.

Required projects

It is important for fellows participating in clinical investigator training to experience the complete spectrum of oncologic drug development from concept development to scientific writing.  Therefore, during protected research time (12 months for medical oncology fellows and 18 months for hematology/oncology fellows), participating fellows should complete the following projects:

  1. Two letters of intent, soliciting consideration of a clinical trial concept from the National Cancer Institute (NCI, CTEP), cooperative group (i.e. Cancer and Leukemia Group B), or pharmaceutical industry.
  2. One protocol. The fellow should design, write, and submit at least one phase I or II protocol to the NCI or OSU IRB.
  3. The fellow should select 1-2 ongoing protocols and serve as the junior PI on these studies, assisting in patient recruitment, consent, and patient management.  The fellow should also attend weekly or bi-monthly meetings of the PI, research nurse, and data managers where toxicity is analyzed and dose escalation decisions made.
  4. The fellow will attend at least 2 half days of clinic/week (one half-day of this requirement should be their continuity clinic) in their area of interest.
  5. The fellow is encouraged to analyze and assimilate data for publication from either a completed clinical trial or a retrospective database.
  6. Clinical investigator fellows are encouraged to participate in the writing of abstracts and presentations at research meetings.
  7.  In addition to the required fellowship conferences, fellows doing clinical research should attend the Weekly Drug Development Meeting (Phase I/II meeting): Wed noon, B410 Starling Loving Hall.
  8.  A clinical research fellow may undertake limited laboratory research related to translational biology, pharmacology, or pharmacodynamic correlative studies that are included in a clinical trial.

National Meetings

Fellows in the Clinical Investigator research pathway will be encouraged to attend the following meetings during the course of their fellowship.

  1. American Society of Clinical Oncology (ASCO) annual meeting
  2. American Association of Cancer Research (AACR) annual meeting
  3. American Society of Hematology (ASH) annual meeting
  4. AACR/ASCO Methods in Clinical Cancer Research Workshop, held annually (July or August)
  5. ASH Cancer Research Training Institute – held annually (July or August)
  6. Spring and Fall National Cancer Institute (NCI) Phase I meetings
  7. AACR/NCI/Drug Development Meeting
  8. Summer Program in Applied Biostatistical and Epidemiological Methods Course: Offered yearly by the OSU Center for Biostatistics/School of Public Health, in July.
  9. Masters of Public Health Program, OSU
  10. Internships at the National Cancer Institute for 1-2 month blocks