The MCW Clinical and Translational Science Institute (CTSI) is seeking applicants for the Scientific Teams Advancing Research Translations (START) TL1 Mentored Clinical Research Training Program. The START TL1 award supports trainees seeking a practical introduction to clinical and translational research. The TL1 award provides full-time research training support for one year for a.) postdoctoral students with clinical degrees (as defined below) who are currently enrolled in a research degree granting program, and b.) pre-doctoral students (i.e. MD/PhD or PhD students) seeking additional training in clinical research.
The overall goal of START TL1 Program award is to increase the number of well-trained clinician-scientists who can lead the design and oversight of future clinical investigations critical to transforming the translational process so that new treatments and cures for disease can be delivered to patients faster.
During the year of research, trainees will participate in workshops that teach grant writing, manuscript writing, and other professional development skills, including best practice strategies to optimize communication skills.
Trainees will also receive Team Science instruction as well as vertically integrated training experiences. Medical and graduate students conducting clinical and translational research will participate in the program along with postdoctoral students who will work together to better translate research findings throughout the entire spectrum of translational research. The program also utilizes activities with high school and undergraduates from our pipeline programs, to reinforce the impact that clinical and translational research has on human populations within our community.
Trainees will participate in bi-annual conferences to present their current studies in a team-based environment.
The training experience will be optimized by the use of Individual Development Plans (IDP).
For this award cycle, applications are being accepted for:
Pre-doctoral awardees (MD/PhD or PhD) conducting clinical and translational research
Postdoctoral awardees (MD, DDS, DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DrPh, DNSc, DPT, PharmD, ND, DSW, PsyD) conducting clinical and translational research
Please read this RFA carefully for complete eligibility requirements related to the applicant and type of research proposed.
The start date for the TL1 award is July 1, 2023. The one-year appointment can be renewed once, at the discretion of the TL1 admissions committee and based on the accomplished work to date, for a total possible appointment of two years.
The MCW CTSI START TL1 training program is part of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program, the goal of which is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the nation’s biomedical, behavioral, and clinical research needs. It is funded through a grant from the National Center for Clinical and Translational Science (NCATS).
Publications arising from any research project receiving support from the CTSI should acknowledge support by stating “Support received by grants TL1TR001437 from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences.”
Please read all parts of this application carefully before applying.
The application submission process is a two-phase process. The Pre-application in Phase I and the Application (and other required documents) in Phase 2 are submitted electronically to the CTSI office for administrative approval via the START Program. Only candidates who are recommended by the Review Committee will be invited to submit an Application in Phase II.
Phase I: Submission of Pre-application
Applicants are to complete the requested personal information and attach a Personal Statement (2-page limit), which includes a description of their academic qualifications, prior training background, previous research experience and interest in the program.
Phase II: Responding to Invitation to Apply
A description of a sound research project that is consistent with the candidate’s level of research development plan must be provided. Please use Arial with font no smaller than 11, single-space text with margins at least ½ inch on all sides. The research plan should be organized under the following sections:
*Plan for Data and Safety Monitoring
Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects.
**Training in Responsible Conduct of Research
The applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete. Candidates should consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Document prior instruction in, and propose plans to receive, instruction in the responsible conduct of research in terms of subject matter and duration of instruction.
The candidate should consult with mentor regarding the development of this section if needed.
Before you apply, please note the following information.
Eligibility criteria for TL1 applicants (established by our funding source, the National Institutes of Health) are as follows:
Applicants will put together a two-person mentoring team.
It is expected that the applicant will identify a mentor in their area of clinical or translational research who is likely to be a member of the faculty in the applicant’s unit. Under guidance from the mentor, the applicant will further develop their proposal that describes the clinical research project to be undertaken. Your mentor is responsible for:
Your mentor should meet with you regularly at least monthly and attend occasional meetings/trainings for TL1 trainees and mentors organized by the CTSI.
The Project Summary should not exceed 3 pages.
The proposed research must fit the following definition of clinical research and be situated somewhere on the translational research spectrum from T1 to T4. See Appendix 1 for more information.
Clinical Research: Research with human subjects that is:
The Project Summary should be organized as follows:
(a) Research design, methods, and aims
(c) Approach, Feasibility, and Environment
Literature citations will not be included in page limits.
Transcript from Doctoral Granting Institution. Postdoctoral applicants should provide a transcript to document graduate and undergraduate education.
Before you apply, please note the following information.
CLINICAL RESEARCH AND CLINICAL TRIALS
Per regulations, Ruth L. Kirschstein TL1 awards fund clinical research, per the following definitions.
Clinical Research¹: Research with human subjects that is:
Clinical Trial2: A research study in which one or more human subjects are prospectively assigned to one or more interventions(which may include placebo or other control) to evaluate the effects of those interventions on health- related biomedical or behavioraloutcomes.
Types of Clinical Trials:
Phases of Clinical Trials: Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions. The CTSI TL1 program is funded by the NIH’s National Center for Advancing TranslationalScience (NCATS). The authorization for NCATS limits specific support for clinical trials only through the end of Phase IIA3. Therefore, if your research project is a clinical trial, it should fit one of the following descriptions:
Phase I trials— Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II trials— Study the biomedical or behavioral intervention in a larger, but still limited, group of people (up to several hundred) to determine efficacy and further evaluate safety.
Phase II trials are further divided:4
Per regulations, Ruth L. Kirschstein TL1 awards fund translational research that occupies a particular space on the Clinical &Translational research spectrum: T1 to T4 (excluding clinical trials from Phase IIB to Phase IV).
The application has a section where you will place your research on the spectrum and provide a two to 4 sentence justification for that placement.
Below are definitions and more information.
Translational research involves moving knowledge gained from the basic sciences to its application in clinical and community settings.This concept is often summarized by the phrases “bench-to-bedside” and “bedside-to- community” research. As the concept of translational health research has evolved with practice and time, it is clear that translational research encompasses a bidirectional continuum. For didactic purposes, translational research has often been described in phases of translation, or “T-phases.”
Source: Harvard Catalyst Pathfinder
The task of CTSA education programs is to prepare the next generation of investigators to conduct clinical and translational research that will address the health care challenges faced in the United States. Creating a recognizable discipline centered on clinical and translational science will help build this workforce. To help establish the discipline, the CTSA Education and Career Development Key Function Committee has drafted national standards for core competencies in clinical and translational science.
The thematic competencies identify common, basic elements that should shape the training experiences of junior investigators by defining skills, attitudes and behaviors that can be shared across multidisciplinary teams of clinician-scientists. The overall goal is to create a competency-based education for training clinician-scientists that will define the discipline of clinical and translational science.
David Brousseau, MD
Chief, Professor, Department of Pediatrics
Division, Emergency Medicine
firstname.lastname@example.org | 414-266-2652
Danny G Thomas, MD, MPH
Professor of Pediatrics
Research Director Pediatric Emergency Medicine
Medical College of Wisconsin
NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.