Clinical Trials and SPA Fall, 2014

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1 Clinical Trials and SPA Fall, 2014 Laura Williams Frances Spalding Sponsored Projects Administration

2 What to Expect Review of key clinical trial concepts A common clinical trial process How SPA fits in the picture Processing delays and other things to consider Final review and steps Resources

3 Did you know?

4 CTSI Hub Pilot Project On Jan. 17, 2013, the U of M launched a pilot project designed to streamline start up, management and oversight of industry-sponsored clinical trials. The project a collaborative effort of the Academic Health Center (AHC), the Office of the Vice President for Research (OVPR), the Controller s Office, Fairview Health Services, and University of Minnesota Physicians (UMP) has the potential to make a significant contribution to the university s ongoing operational excellence efforts. For more information check:

5 CTSI Hub In January, 2014, at the expiration of the pilot, the CTSI Hub launched. The CTSI is part of the AHC, and is supported through the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, grant UL1TR It is one of approximately 60 CTSA research institutions nationwide. BMHI, one division of CTSI, is responsible for CTMS OnCore Implementation. Phased roll out has begun, and Pediatrics, Oncology and Cardiovascular are using the full enterprise versions of CTMS. CTMS support also housed in CTSI Consolidation is ongoing and expected to broaden

6 What is a Clinical Trial? How is it different than Research? Clinical Trial: A research study to test drugs, procedures or testing technologies to determine whether these are effective and/or safe. Research: A systematic, intensive study intended to increase knowledge or understanding of the subject studied.

7 Why faculty would consider clinical research? Opportunity to do good science that helps people For an individual principal investigator it provides the possibility to approach science with a new type of research

8 Definition of the term, sponsor in clinical trial research When you see the term sponsor be aware of the definition of the role: Regulatory sponsor FDA responsible entity Financial sponsor Entity that provides the money for the trial

9 How to locate a clinical trial? Check with colleagues now working on a study who might know of other possibilities. Locate and speak with a company s monitor who works with like studies PI might be interested partnering with. Check with This FDA website lists all existing and planned clinical trials

10 Clinical Trial Sponsor usually fall under one of these categories? A governmental organization A pharmaceutical company A bio-technology company

11 Most clinical trials have common elements Depending on the type of product and the stage of its development, investigators: 1. Enroll healthy volunteers and/or patients into small pilot studies initially 2. Followed by larger scale studies in diagnosed patients that often compare the new product with the currently prescribed treatment

12 A common clinical trial During the clinical trial, the investigators: 1. Recruit patients with the predetermined characteristics 2. Administer the treatment(s) 3. Collect data on the patients' health for a defined time period

13 A successful clinical trial includes some key elements Protocol Investigator Brochure

14 What is a clinical trial protocol? It describes the scientific rationale, objective(s), design, methodology, statistical considerations, and organization of the planned trial. It contains a precise study plan for executing the clinical trial, not only to assure safety and health of the trial subjects, but also to provide an exact template for trial conduct by investigators.

15 Another common element is an investigator brochure An Investigator Brochure is intended to provide the PI with the knowledge necessary for management of study conduct and study subjects throughout a clinical trial.

16 Investigator s Brochure includes A brief description of the drug substance and formulation A summary of the pharmacological and toxicological effects of the drug A summary of the information relating to safety and effectiveness from prior studies. A description of known side effects.

17 So what is the process? The company sends the brochure and protocol to the PI. The PI reviews the information and decides to participate. PI works with University to set up the clinical trial.

18 At the U of Minnesota There are at any one time 400 active clinical trials. Budgets B&I sponsors are calculated at a 26% Total Direct Cost base Budgets for Federal Sponsors are calculated at a 52% Modified Total Direct Cost base

19 So how does all this information translate to the University of Minnesota? The PRF and supporting documentation are collected and submitted to SPA in two stages: An initial stage that allows for negotiation while documentation is being fine tuned A final stage where the final documentation is submitted and an agreement is in place

20 Industry Sponsored Clinical Trials follow an Expedited Review process for PRFs The Expedited Review assists the PI by reducing the time needed to process the clinical trial contract. Check the SPA webpage at: edures/b&iclinicaltrials.html

21 First step of the Expedited PRF The PRF is prepared but signed only by the principal investigator (PI), then delivered to SPA with the contract, simple budget, and protocol. SPA will initiate the review/negotiation process within two weeks of receipt the initial documents.

22 Preaward If work begins and expenses are incurred before the contract is finalized, the PI must complete and forward a Preaward/Advanced Account Request form to SPA: along with a fully signed PRF explaining to SPA why a pre-award account is being requested. An example of a pre-award cost is the IRB $2500 fee along with the associated IDC.

23 The budget for the clinical trial is developed Review the study protocol Separate the research from the standard care Define personnel roles, personnel time needed and hourly cost Estimate costs for studies/procedures Any misc. costs that might not be obvious at first glance?

24 A resource for University faculty is CTSI? CTSI stands for Clinical and Translational Science Institute. The mission of CTSI is to improve the health of our communities through collaborative clinical and translational research. Webpage:

25 CTSI provides a wide range of clinical research services Consultation on CTSI resources Grant preparation Statistical collaboration and consultation Regulatory assistance (FDA, IRB applications; clinical trial monitoring) Study audit (record and reporting) Protocol writing IND/IDE submission ( IAP )

26 U of MN compliance issues need to be considered is a link provided by the OVPR which can help guide you with policy that may be applicable to the clinical trial being considered.

27 Something else to be aware of All clinical research projects requesting services from the University of Minnesota Physicians (UMP) and/or Fairview will be required to conform to the Clinical Research Budgeting and Billing policy: It is essential that the PI determine early in the process which cost elements are standard care and which are research-specific. For each clinical research project, the PI must document the financial responsibility for paying for each service, drug, test or procedure.

28 TASCS= Time and Study Collection System Fairview s system to delineate the services, drugs, devices, tests, and procedures rendered for clinical research. Check TASCS webpage for information and resources: esearchaccountsandbilling/tascs/s_014082

29 Second step of this two part process for the SPA expedited review After negotiations on the protocol are completed and the budget is finalized, the PRF is retrieved and updated, submitted to the department and college for review and approval.

30 Submission to SPA Once approved by all individuals included on the PRF, a copy of the documents are delivered to SPA. Talk with your Grant Administrator on the best method of submission for the final step of the process.

31 Some delays that hold up processing clinical trials Publication clause Confidentiality clause Intellectual Property clause Office of the General Counsel review Patents & Technology input PI input

32 Master Agreements The University of Minnesota has in place approved Master Agreements that shorten the negotiation process and speeds processing.

33 Final Review before submitting SPA will not sign off on contracts until it receives the fully signed PRF, final protocol and budgets.

34 Something to consider There is a parallel path with the IRB approval process, (users do not need to fully complete IRB before sending it to SPA however an approved IRB will need to be in place before any human subject work can begin). The IRB fee is waived for investigator sponsored clinical trials.

35 Resources SPA and your Business and Industry representative, x Laura Williams, Frances Spalding, SPA training Coordinator, Other SPA classes can be found at: nd%20calendars/trainingschedule.html#descriptions

36 Check out: Free on-line classes on a variety of clinical trial topics

37 Did you know about SPECTRUM? SPECTRUM (Sponsored Projects Education Certification Training at the University of MN) has been developed and implemented by a cross section of the University research community. There are approximately 34 courses identified to be developed and delivered. SPECTRUM courses started being rolled out during FY10 and in FY11. As soon as enough core courses have been developed, plans for the implementation of the certification program will be announced. Check the Training Services webpage: for additional information.

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