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

Office of Research and Innovation

STUDY AND TRIAL PLANNING

Study and Trial Planning

For general inquiries about study and trial planning, please contact:

Consultations

BERD members provide consultations intended as one-time meetings to clarify and discuss statistical and study design concepts, tips for improving data management and analysis, guidance in interpreting statistical results and suggestions for improving manuscripts.

Collaborations

BERD members provide numerous collaborative services to help assure that research studies and trials are conducted in the most high-quality, reproducible, and translatable manners possible. In particular, we provide the following services for long-term collaborations.

Data Management

  • Define and identify cohorts
  • Plan and create a data management plan
  • Provide data validation (range checks, missing data assessments, etc.)
  • Collaborate and coordinate activities with Bioinformatics Core (BIC)
  • Tools: SQL, MS SQL Server, Excel, REDCap
  • Plan and create analysis set

Interim or Final Statistical Analysis

  • Conduct participant allocation/randomization or generate a blinded randomization schedule
  • Perform analyses for planned continual reassessments and design adaptations, such as response-adaptive allocation, early termination, dose/arm expansion and sample size re-estimation
  • Statistical expertise: estimation and hypothesis testing, longitudinal data analysis, survival analysis, mixed effects modeling, generalized additive modeling, machine learning/artificial intelligence and Bayesian modelling

Dissemination

  • Draft and review relevant sections for peer-reviewed manuscripts
  • Support abstract, poster and oral presentation support

All projects supported by extramural funding must provide funding to cover the efforts of BERD members. If such support is made, BERD members will provide all on-study research activities described in the Statement of Work at no additional charge. Requests for projects that have been partially completed will be deprioritized, and BERD members reserve the right to deny assistance for projects that are ill conceived or do not allow sufficient time for completion.