Center for Clinical Trials Study Design Consulting Service

The ICTR provides members of the Johns Hopkins research community a consulting service on questions relating to study design and conduct of clinical trials, and meta-analysis of clinical trials. Faculty of the Center for Clinical Trials and Evidence Synthesis (CCTES) are available to meet with researchers to discuss their proposed research plan. Housed in the Department of Epidemiology in the Bloomberg School of Public Health, the interschool CCTES is dedicated to the promotion of clinical trials as a method of evaluation of treatments for health problems. The mission of the consulting service is to provide intellectual and methodological input into clinical research studies and research synthesis initiated by faculty of Johns Hopkins University.

Areas Covered by the CCTES Consulting Service:

The CCTES offers investigators an opportunity to discuss and formulate their research question about the design, conduct or analysis of data from clinical trials. Types of support offered are:

  • Assessment of whether a clinical trial is an appropriate design for the investigator’s research question.
  • Advice on framing specific aims of clinical trials and other key components of research funding applications for clinical trials.
  • Guidance on protocol development, including eligibility criteria, definition of treatment interventions, randomization, outcome measurement, masking (blinding), stopping rules, etc.
  • Advice on the design of data forms and other study documents
  • Discuss data monitoring and requirements for reporting adverse events in clinical trials.
  • Advice on meeting regulatory requirements for clinical trials, e.g., registration of clinical studies, applications for investigator held IND’s
  • Advice on dealing with funding agencies.

Since systematic reviews of the literature including (network) meta-analysis are a core competence of CCTES faculty, we also offer consulting on conduct or interpretations of systematic reviews and meta-analysis.

Statistical analyses and data management services are not offered by the CCTES. Faculty needing support in this area will be referred to the consulting service of the Biostatistics Center and Data Management service offered by the ICTR. A close collaboration with these ICTR consulting services will be maintained in order to avoid overlap and duplication of consulting services.

Format of the CCT’s Consulting Service:

We will arrange a meeting of CCTES faculty with JHU faculty, staff or students requesting the service (free of charge). JHMI faculty are strongly encouraged to submit a request for the service as early in the planning of the research project as possible to maximize potential benefit from the consulting. The CCTES consultatns may decline requests that are too close to a deadline to provide anything useful.

After the initial meeting, the service provides up to two hours of free support of the research project in order to provide supporting material or literature discussed during the initial meeting. A collaboration beyond the support through the ICTR (approximately 3 hours per consult) is beyond the scope of ICTR consulting services. We do not in general work with investigators on grant applications or conduct of clinical trials; our mission is to provide expert advice.

Contact:

You can request the Study Design consulting service through the ICTR Connection Request system by visiting https://ictrweb.johnshopkins.edu/ictr/?RequestCCT

Co-director: Kay Dickersin
http://faculty.jhsph.edu/default.cfm?faculty_id=1695

Co-director: Janet Holbrook
http://www.jhsph.edu/faculty/directory/profile/3909/Holbrook/Janet