Statistics Collaborative - Design and analysis for biomedical research

Therapeutic AreasTherapeutic Areas


Statistics Collaborative, Inc. (SCI) has considerable experience in the development of vaccines for commercial as well as governmental and nonprofit sponsors. We have reported on safety, immunogenicity, and efficacy.

The trials on which SCI has worked have covered a range of diseases and have featured many different designs. Most have dealt with preventive vaccines and have included pre-clinical studies and Phase 1, 2, 3, and 4 vaccine studies for malaria, influenza, HIV/AIDS, chickenpox, shingles, respiratory syncytial virus (RSV), human papilloma virus (HPV), anthrax, and dengue fever. Some have studied therapeutic cancer vaccines. Some have been challenge studies, where investigators deliberately infect volunteers (who have signed detailed informed-consent forms), while others have been field trials, which are conducted in areas where disease is endemic.

Examples of SCI’s work in vaccines:

  • Seasonal and pandemic influenza: SCI prepared final statistical reports for Phase 1, 2, 3, and 4 trials of FluMist® inhaled influenza vaccine and represented the sponsor to the Food and Drug Administration (FDA). SCI has also worked with several companies that are developing vaccines for pandemic influenza.
  • Malaria: SCI has designed and analyzed several animal studies and Phase 1a, 1b, 2a, and 2b trials with the PATH Malaria Vaccine Initiative (MVI), GlaxoSmithKline plc (GSK), the National Institutes of Health (NIH), the United States Army, and the United States Navy. Our contributions have included designing protocols; creating case report forms and databases (including a database generator for Phase 1 and 2 malaria studies); generating randomization schedules; and developing statistical analysis plans and interim and final reports.
  • Dengue fever: SCI prepared the final analysis of a Phase 1 study for the U.S. Army comparing a tetravalent dengue vaccine to four different monovalent dengue vaccines. In contrast to influenza and malaria, dengue vaccines cannot be tested in challenge trials. Therefore, the immunogenicity analyses must be extensive.