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Clinical Trials Consulting

Clinical Trials Consulting

ITHS seeks to ensure and support the completion of high quality clinical and translational research. Successful execution of rigorous, high-impact studies begins well before study implementation. This is why ITHS provides clinical trials consulting through the new ITHS Scientific Success Committee. This committee offers guidance on issues related to the design of research questions, approach, and strategy from early stages of development until implementation of a study. The committee provides feedback on study design and feasibility and connects investigators to programs and other resources that can improve the quality and efficiency of proposed research.

Services

We currently offer guidance on:

  • Developing discrete, actionable research questions from an initial idea
  • Refining and prioritizing research questions
  • Translating research questions into testable hypotheses
  • Evaluating the potential impact and generalizability of proposed research
  • Defining measures that are clinically significant and meaningful to patients, providers, and communities
  • Developing a study design that will enable adequately powered statistical testing of hypotheses
  • Assessing feasibility of study design in selected study settings and operational considerations that may require changes to study design
  • Identifying critical questions to address in pilot/feasibility studies
  • Determining resources required to successfully implement study (with feedback on budget)
  • Designing a feasible and rigorous data collection and management plan

Consultation with the Scientific Success Committee is provided at no charge. Depending on your project’s needs, we may refer you to other ITHS resources, some of which may be subject to program fees. Our Research Navigator is available for personalized guidance to our portfolio of services, educational programs, funding opportunities, and other research resources.

Scientific Success Committee Approach

Scientific Success Committee Approach

The Scientific Success Committee supports researchers through any phase of study development before IRB approval.

Interested researchers contact the ITHS Research Navigator to request a meeting with the Committee. Our Research Navigator evaluates the request and then works with the researcher to prepare materials and a short presentation for the Committee.

Committee panels include biostatisticians and experienced clinical investigators. Meeting content includes a project overview by the researcher followed by discussion, questions for the research team, and the Committee’s recommendations. Up to three studies will be reviewed at each monthly meeting.

After the meeting, researchers are provided with a written project support plan detailing the Committee’s feedback, recommendations, and suggested road map for next steps.

Recommendations may include referrals to existing resource groups that contract with researchers to provide fee-for-service support. The cost of these services, if engaged, will be the responsibility of the researcher.

Who Can Use the Scientific Success Committee?

Who Can Use the Scientific Success Committee?

The Committee is currently open to investigators at UW, Fred Hutch, Seattle Children’s, or other Seattle area institutions. We plan to open the Committee to investigators across WWAMI later this year.

Contact Us

Contact Us

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.