C. KENNETH AND DIANNE WRIGHT CENTER
FOR CLINICAL AND TRANSLATIONAL RESEARCH

STUDY AND TRIAL PLANNING

BERD members are excited to help you design your research study or trial and develop a grant proposal. In particular, members will work closely with researchers to:

• Refine research aims and ensure that hypotheses are testable
• Develop an appropriate and feasible study design in support of your research aims
  • In particular, BERD members are experts in the design of adaptive trial and study designs, which are methods (such as response-adaptive randomization, early termination, sample size re-estimation) used to enable projects to end more quickly, more ethically and with more reproducibility than traditional designs.
• Define and phenotype measurements and observation schedules
• Draft the statistical analysis plan (SAP)
• Estimate and justify sample size
• Conduct light pilot analyses of preliminary data
• Plan budget and draft budget justification
• Help draft the proposal, particularly with respect to sections on study design, measurements, statistical analysis and sample size

These services will be provided by BERD members free of charge provided that BERD member efforts are sufficiently included in the project budget. If projects exceed the scope of Wright Center BERD members, they may be referred to the Biostatistical Consulting Laboratory or be subject to a fee schedule. BERD members reserve the right to deny assistance for projects that are ill conceived or do not allow sufficient time for completion.