Center for Clinical Trials Study Design Consulting Service
Through the ICTR, Center for Clinical Trials (CCT) faculty members offer a consulting service on questions relating to study design and conduct.
Housed in the Department of Epidemiology in the Bloomberg School of Public Health, the interschool CCT is dedicated to the promotion of clinical trials as a method of evaluation of preventive and therapeutic approaches to health problems. The goal of this 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 CCT Consulting Service
CCT Study Design Consulting offers a thorough discussion and framing of the research question that can be addressed through a clinical study. Types of support offered are:
- Help in identifying appropriate study design, which is not restricted to clinical (randomized) trials.
- Input into protocol development, including eligibility criteria, definition of interventions, randomization, outcome measurement, masking, stopping rules, etc.
- the design of data forms, coordination of the study, data monitoring and reporting, including advice on registration of clinical studies and reporting and dissemination of protocols and completed clinical studies
- Advice on dealing with sponsors of industry-funded studies.
Since systematic reviews of the literature including (network) meta-analysis are a core competence of CCT faculty, we also offer consulting on any aspect of systematic reviews and meta-analysis.
The statistical analysis and data management (coordinating center) is not covered by the CCT. 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
CCT Study Design Consulting will organize an initial meeting of 1 hour of CCT faculty with JHU faculty 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 CCT may decline requests that are too close to a deadline to provide anything useful.
After the initial meeting, the service provides an additional 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 (the 3 hours) is welcome but will depend on the JHU and CCT faculty and potential grant support.
Janet Holbrook, Director