Statistics Collaborative - Design and analysis for biomedical research


Protocol design

Statistics Collaborative, Inc. (SCI) has designed trials and helped develop protocols for trials spanning many disease areas and all phases of drug development. While we focus on the statistical aspects of a protocol, these issues are integrally intertwined with other elements of the trial, including study outcomes, sample size calculations, randomization procedures, and the timing and method of data collection.

Examples of SCI's work in protocol design:

  • Candidate malaria vaccines: We have developed numerous protocols for Phase 1a, 1b, 2a, and 2b trials of candidate malaria vaccines. We have played an integral role in designing the study outcomes; selecting the trials' sample sizes; determining the visit schedules to capture appropriate data for analysis; creating case report forms and databases to collect these data; generating randomization schedules; and developing statistical analysis plans.
  • Neurological disease: For a small biotechnology company with expertise in neurological disease, we helped develop Phase 1, 2, 3, and compassionate-use studies.
  • Cancer: For a large biotechnology company with expertise in cancer research, we were responsible for the statistical design for pre-clinical and Phase 1 trials.