The CTSI Pilot Translational and Clinical Studies Program is supported by the Advancing a Healthier Wisconsin Research and Education Program (AHW REP) and the National Institutes of Health (NIH). For the 2017 cycle, the CTSI is set to fund 12 awards up to $50,000. These awards are intended to stimulate inter-institutional and interdisciplinary translational and clinical research within and among the CTSI partner institutions. These awards will promote best practice in team science research by supporting research teams with significant levels of interaction and integration.
Summary: The fundamental goal of this funding path is to stimulate clinical and translational research among the institutions that comprise the CTSI of Southeast Wisconsin through meaningful collaboration and high quality team science. This award uses a multiple PI model to encourage inter-institutional and interdisciplinary collaboration, between clinical and basic biomedical scientists, social scientists, ethicists, engineers, biostatisticians, informatics specialists, and all members of clinical health care delivery teams.
This program is designed to advocate, facilitate, and foster the continuum of research from bench to bedside, and from bedside to community practice. In a sense, translational research focuses on discovery and the application of scientific findings into a real-world setting. It is the goal of the CTSI to diminish the barriers between institutions and disciplines, while encouraging novel approaches to solving complex health related problems. Ultimately, our goal is to improve health outcomes by creating new, bidirectional flows of information between our biomedical research enterprise and the community we serve.
This pilot award program funds clinical and translational research, defined as follows:
The NIH defines clinical research in three parts:
The NIH defines translational research as: ‘Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science. 2
Applications should address one of the four T-levels on the CTSI Translational Continuum, based on NIH guidelines.
T-1 Translation to Humans – Clinical Insights: Goal is to identify and analyze the effects of an intervention or relationship on the human condition or environment. The effect of an intervention, the effect of a relationship. Studies with human participants that yield knowledge about human behavior, physiology, pathophysiology and the potential for intervention (i.e. diagnoses, therapies, etc.).
T-2 Translation to Patients – Practice Implications: Goal is to identify and analyze the optimal effects of an intervention or relationship on the human condition or environment. The optimal effect of an intervention, or the optimal effect of a relationship.
T-3 Translation to Practice – Goal is to incorporate into practice the optimal intervention or relationship. Phase 4 clinical trials – focus on post-marketing analysis. Includes health services research & community-based participatory research (dissemination, communication, implementation research).
T-4 Translation to Communities – Goal is to provide communities with the optimal intervention or relationship. Studies focusing on disease prevention through life-style and behavioral modifications. Documents “real-world” health outcomes of population health practices associated with improved disease prevention and reduced medical costs. Results in true benefit to society.
498 kBView the CTSI Translational Continuum
1 Glossary of Terms for Human Subjects Protection and Inclusion Issues, based on the 1997 Report of the NIH Director’s Panel on Clinical Research.
2 National Institutes of Health. RFA-RM-07-007: Institutional Clinical and Translational Science Award (U54) Mar2007.
* This program has an accelerated nature and only a 12 month funding period. If your project requires working with federal agencies such as NIDA, FDA (e.g., IND, IDE applications) or pharmacological agreements (e.g., clinical trial agreements, material transfer agreements), you must contact the CTSI Pilot Translational and Clinical Studies Program Director, Ramona Tenorio, PhD at 414-955-2537, prior to applying.
Cardiovascular Research, Cancer Research, and Community-Engaged Health Disparities Research are special emphasis categories for 2017. Additional review weight will be applied to research in these respective areas.
Novel Approaches and Technologies focus on the development of new and innovative technical resources. Projects that involve design and development of novel approaches or technologies which are accessible and efficient to monitor health or deliver care in real-time are highly encouraged to apply. Additional review weight will be applied to research incorporating novel approaches or technologies. Selected proposals are intended to increase the efficiency and/or rigor of multidisciplinary clinical and translational research.
To ensure that the results of scientific research will be used to directly benefit human health, proposals in all disciplines relevant to biomedical investigation will be considered for funding. Criteria for funding of any proposal include: 1) the clear potential to directly translate anticipated results into improved preventative health, diagnostics, therapeutics or health outcomes for our southeast Wisconsin community; and 2) the potential for proposed studies, when completed, to generate extramural funding.
An Intent to Apply Form will be reviewed for each intended application by the CTSI Pilot Translational and Clinical Studies Program. Projects meeting Intent to Apply standards will be sent an email with a personalized link to proceed to a full application.
The CTSI Pilot Award Committee (PAC) will initially review all applications for technical feasibility and compliance with above requirements. CTSI PAC is comprised of at least one member from each of the partner institutions (MCW, MSOE, MU, and UWM), to ensure equitable representation of all the CTSI partner institutions.
All applications will go through peer- review, an in-person panel review, and a post-panel review.
Projects are reviewed based on their selected Translational Track. Specific review criteria for each Translational Track can be viewed in the documents below.341 kBTranslational Track 1 Review Guide and Score Sheet 286 kBTranslational Track 2 Review Guide and Score Sheet
THE CTSI MUST COLLECT AND SUBMIT TO NCATS, 30 DAYS PRIOR TO FUNDING APPROVAL, THE FOLLOWING:
STEM CELLS – INFORMATION REQUIRED
CTSI seeks to promote the highest quality of human subjects research, therefore as part of the post award process, pilot projects that were ranked 4.5 or higher on the NIH Likert scale, will be analyzed for trends in deficiencies. The purpose of this analysis will result in generalizable knowledge, as required by NCATS, and be used for educational training opportunities to enhance translational science and investigator knowledge.
Note: This quality improvement initiative will have no impact on the CTSI Pilot Review process. All information shared as educational material will be de-identified. For any questions or concerns, please contact the project lead, Amit Gode, MD, MCW CTO Director at email@example.com.
The online Intent to Apply Form must be completed and received 8/12/2016, 11:59pm CDT.
All applications must be received for CTSI administrative approval via invitation by 9/30/2016, 11:59pm CDT. Submissions by any other means will not be accepted.
Please download and complete all of the documents prior to completing full application.
All applications must be routed through eBridge and must be received by the Office of Grants & Contracts (GCO) no later than 5 business days before the submission deadline in this RFA. Different departments may have different deadlines for obtaining departmental approvals prior to receipt by the Office of Grants & Contracts.
For MU investigators, the application must be registered via the routine Proposal Registration process with the Office of Research and Sponsored Programs prior to submission. This process is required for proposals in which MU is the prime applicant and those for which MU is the collaborating applicant receiving funds. Remember that Marquette requires that a signed institutional letter of intent is in hand from all sub-awardees or collaborating institutions who will be receiving funds (i.e. MCW, UWM, MSOE, etc.) from a grant in which MU is the prime applicant prior to submission. Please contact an ORSP staff member early in your application preparation process as we can assist with forms, budget formulation, proofreading, securing sub-award letters of intent, etc.
For UWM investigators, full applications must be routed using the WISPER system and approved by the Office of Sponsored Programs prior to submission to MCW. UWM applicants with new collaborators must process the sub-award within the MCW timeline. Letters of intent do not require a WISPER record.
For MSOE investigators, please contact Tom Bray, Dean of Applied Research, 277-7416 or firstname.lastname@example.org.
AHW REP and NIH Funding Acknowledgment: Important Reminder – Please acknowledge the AHW REP and NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement. Please see AHW REP website for Acknowledgement Policy