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Project Development Teams Tammy J. Sajdyk Translational Coordinator tsajdyk@iupui 278-7488

Project Development Teams Tammy J. Sajdyk Translational Coordinator tsajdyk@iupui.edu 278-7488. What are Project Development Teams (PDTs)?.

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Project Development Teams Tammy J. Sajdyk Translational Coordinator tsajdyk@iupui 278-7488

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  1. Project Development TeamsTammy J. SajdykTranslational Coordinatortsajdyk@iupui.edu278-7488

  2. What are Project Development Teams (PDTs)? A PDT is a committee of multidisciplinary researchers who assist investigators in developing ideas/hypotheses into well-designed translational projects. This goal is accomplished by helping investigators with protocol development; pilot funding; facilitation of collaboration with other investigators; and access to Core Resources on IUPUI and Purdue campuses.

  3. How are PDTs Organized? TRAC1 – Basic/PreClinical TRAC2 – Adult Clinical Pediatrics – Pediatrics Clinical TRIP - Community–Based Research Behavioral/Population Sciences - Epidemiological Studies & Clinical Intervention Studies Purdue – Basic and Clinical http://www.indianactsi.org/programs/pdt

  4. How Would you Describe the Function of each PDT? Translational research: Research that transforms scientific discoveries arising in the lab, clinic, or population into new clinical tools and applications that reduce incidence, morbidity, and mortality.

  5. Interface with basic and clinical scientists in order to design and implement high quality, feasible, fundable translational research projects TRAC 1 • Provide investigators a point of access to multidisciplinary research expertise, biostatistics, regulatory and infrastructure support, and pilot funds. • The Review Committee meets twice a year, Spring and Fall.

  6. The TRAC2 PDT (adult clinical) reviews a diverse type of applications, including those moving from animal models/basic science into all phases of clinical trials. The team meets the first and third Monday of each month. TRAC 2

  7. Pediatrics • Interface with basic and clinical scientists to design and implement high quality, feasible, fundable clinical/translational research projects. • Providing investigators access to multidisciplinary research expertise, biostatistics, IRB/regulatory and nursing support, and pilot funds. • Not simply a review group, but is a team that will discuss ideas and concepts with investigators and fully assist in developing research projects. • The committee meets on Monday of each week.

  8. TRIP (Translating Research Into Practice) • Multidisciplinary teams to assist and guide in the development of projects that are specifically translating research into practice through implementation, system redesign, patient safety, human factors engineering, or medical informatics. • The TRIP PDT seeks to expertly foster research in the following areas:New strategies adapted for implementation, system redesign, and dissemination of evidence-based practice • New treatment approachesincrease in evidence-based patient careSystem redesign health issuesIncreasing awareness of the importance of studying and improving processes for effectively translating research into practiceThe team meets the second Wednesday of each month.

  9. Behavioral/Population Sciences • Basic research on methods and theories, epidemiological research, testing of clinical interventions, and translation of results to patients, families and communities. • Research can address various areas across the life/disease continuum including prevention, early detection and treatment of diseases, management of chronic health conditions, healthy life style choices, community and environmental research, public health, and end of life care. The Behavioral/Population Sciences PDT meets the first Monday of the month

  10. How does a PI Initiate a Request for Assistance from a PDT? Go to http://www.indianactsi.org/programs/pdt and download either the PreClinical Request Form or the Human Subjects Request Form

  11. INDIANA CLINICAL TRANSLATIONAL SCIENCE INSTITUTE REQUEST FORM FOR PROJECT DEVELOPMENT ASSISTANCE FOR RESEARCH INVOLVING HUMAN SUBJECTS* *Note: Human Subject Projects might include, but are not limited to: Specimen collection, chart reviews, surveys, health services research, clinical trials and/or new drugs or devices for humans. Section I: Personnel Information Name: Date: Department: Faculty Rank: Years at Rank: Referred to CTSI by: Help Desk PDT Committee Member Colleague Other: Division: Protocol Title: Co-investigators:

  12. Section II: Project Description Concept Status (Check all that apply) First Concept/Idea Partial Protocol Complete Protocol Grant Submission Planned Unfunded Grant Submission/Need more data Other (Please explain) Please provide a 1 page concept protocol in the space below. If you have a more extensive protocol or grant submission you can attach that document, however, please ensure all points below are included. Points to include are: Background and Rationale for Pilot Study (Note: Make sure to include why you feel this project is ‘translational’ in nature). Hypothesis Potential study population Plans to submit for external funding and external funding source Lead investigator Biosketch or CV

  13. SECTION III: RESOURCES REQUESTED _______NewProtocol Development _______Budget Development _______Pilot Funding _______Feedback on Current Protocol _______Nurse Coordinator/Res Assist _______IRB Support Please send the Completed Request Form to tsajdyk@iupui.edu If you have any questions regarding this form please contact Tammy Sajdyk at 278-7488 or via the above e-mail address.

  14. Source: IUSCC ITRAC

  15. Examples of Successful Projects within the PDTs

  16. Pediatric PDT • Pediatric basic scientist makes an in vitro observation of the effect of glucose on endothelial progenitor cells. • Meets with PDT to explore extending studies to pregnant women and their babies • Clinical design and protocol written by PDT, including biostatistics • PDT supports IRB submission and approval • Research nurse assigned to obtain sample for pilot. Pilot funds provided by PDT ($10K) • R21 submitted and funded. Manuscript published in Diabetes • Information from R21 leads to R01 submission. Favorable score but resubmission necessary. • Second R01 from this project also being prepared.

  17. TRAC 1 PDT • Basic Scientist contacts translational officer to fill out PreClinical request form. • A meeting is arranged to discuss the PI’s project regarding an animal model of panic disorder. • The translational officer and the PI work together to create a map of the project. • The PI presents to the review committee in November and receives partial funding for the project by December 1. • The PI submits a K99/R00 grant to NIH in Feb.

  18. TRAC 2 PDT • Clinician fills out request form and is scheduled to present to the committee. • The PI in infectious disease presents evidence showing that investigating multidrug resistant gram negative bacteria in obese pts is critical to the health of these pts. • The Committee provided extensive feedback and assigned a mentor to the PI • The PI worked with the mentor and returned to the committee in the beginning of Feb. The committee redesigned her study and determined the new direction was a better fit for the TRIP PDT • The committee contacted the TRIP project manager and the PI will be presenting her new protocol on March 11.

  19. TRIP PDT • Basic scientist (geologist) studying soil samples for lead finds a potential connection with lead poisoning in children and soil levels. Contacts Peds PDT member for mentoring. • Works with mentor and comes toPediatric PDT to present. Committee discusses the proposal extensively with the PI and determines a collaboration with Health Services Research is important. In addition, they reroute the proposal to the TRIP PDT. • TRIP PDT hears the collaborative presentation and following a detailed discussion determines that this project is important for the community and provides funds and assistance with mining the Regenstrief Database.

  20. Behavioral/Population Sciences PDT • Junior VA Faculty in Occupational Therapy interested in gait for stroke patients. • The PI and Co-PI presented to the committee in Jan. The committee provided extensive feedback. • The committee met with the PI again in Feb and provided additional assistance in protocol development. • The protocol will be reviewed and discussed for funding in the next couple of weeks.

  21. Questions

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