Infectious Disease
Statistics Collaborative, Inc. (SCI) has considerable experience in infectious disease, both in adults and in children. From our founding in 1990, we’ve worked on diseases caused by bacteria, viruses, retroviruses, and parasites. Some of the trials have investigated antibacterials or antivirals, while others have studied vaccines. Still others have studied methodologies for early detection of disease.
Drs. Verter and Wittes have served on Food and Drug Administration (FDA) Advisory Committees that have dealt with setting margins for non-inferiority trials in infectious disease. They have also been ad hoc members of an Advisory Committee for a treatment for influenza. Dr. Schumi worked on HIV/AIDS before she joined SCI and has continued to do so during her tenure here.
In addition to our work with industry and with FDA, we collaborate with nonprofit groups that develop vaccines or treatments for malaria, tuberculosis, and HIV/AIDS.
Examples of SCI’s work in infectious disease:
- Hepatitis C: SCI provided statistical reporting and coordination for a Data Monitoring Committee (DMC) for a Phase 3 study of a novel treatment formulation.
- Vancomycin-resistant enterococci (VRE) infection: SCI reviewed the available scientific literature for roughly 40 studies to determine patient risk factors and aspects of therapy that might predispose patients to nosocomial VRE colonization and blood stream infections.
- Sepsis: SCI has supported several DMCs monitoring Phase 2 and 3 studies in different populations with sepsis. Some trials studied adults at high and moderate risk; other trials studied children with sepsis or meningococcemia. The studies have used a variety of investigational therapies as well as common standard-of-care. Because of the severity of the disease and the toxicity of many of the therapies, SCI has assisted in developing DMC futility and safety stopping guidelines.
- Seasonal and pandemic influenza: SCI has been involved with the clinical development of FluMist®, an inhaled influenza vaccine, from Phase 1 through Phase 4 trials. We have assisted with protocol development, with analysis, and with the writing of the clinical study reports (CSRs) for the FDA submission.
Examples of papers:
- Rhorer J, Ambrose C, Dickinson S, Hamilton H, Oleka N, Malinoski F, Wittes J. Efficacy of live attenuated influenza vaccine in children: a meta-analysis of nine randomized clinical trials. Vaccine 2009; 27:1101-1110.
- Derkx B, Wittes J, McCloskey R. Randomized placebo-controlled trial of HA-1A, a human monoclonal anti-endotoxin antibody, in children with meningococcal septic shock. Clin Infect Dis 1999; 28:770-777.
- Fanaroff AA, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Phillips JB III, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. The incidence, presenting features, risk factors and significance of septicemia in low birth weight infants. J Inf Dis 1998; 17:593-598.