We manage and analyze data collected by this group, which supports the world’s largest network of expert AIDS clinical and translational investigators and therapeutic clinical trial units. Established in 1987 and funded by the National Institute of Allergy and Infectious Diseases, the AIDS Clinical Trials Group has driven advancements in the treatment of the disease, which affects 39 million people globally, according to the World Health Organization.
Frontier Science is a key collaborator with the International Breast Cancer Study Group at the Dana-Farber Cancer Institute. Our Treasurer and Director, Dr. Richard Gelber, has participated in every study conducted by the group since its launch in Switzerland in 1977. Supported by data management, statistical analyses and other Frontier Science services, the work of IBCSG has been cited around the world as instrumental to the development of many new breast cancer therapies.
The transmission of AIDS from mother to fetus continues to be a major problem in many parts of the world, while in the United States it currently is a relatively rare occurrence. The latter can be attributed to the work of IMPAACT; the challenge is to extend those positive results to other countries. Of the many IMPAACT studies currently underway the largest is PROMISE, Promoting Maternal and Infant Survival Everywhere. Frontier Science is an IMPAACT collaborator, providing a comprehensive range of data management, statistical analysis and technical services.
What are the long-term expectations for those children who are born with HIV-AIDS, infected via their mothers during pregnancy? This is the question behind this decades-long study, supported with Frontier Science research services. Since 2005, PHACS has been building a body of data to understand how HIV affects sexual maturation, pubertal development, and socialization of such pre-adolescents and adolescents. A primary challenge was to assess the long-term safety of fetal and infant exposure to prophylactic antiretroviral therapy. Follow-up studies are continuing.
OlympiA is a randomized, double-blind, parallel group, placebo-controlled multi-center Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. This international study is sponsored by AstraZeneca and the NCI and is conducted by a collaboration including the Jules Bordet BrEAST clinical trials unit; Breast International Group (BIG); Frontier Science; the NRG clinical trials group; and Myriad Genetic Laboratories. Frontier Science provides project management; statistical leadership, design and analysis; randomization; data management; and programming. A separate firewalled Frontier Science statistical unit provides independent statistical analysis for the Data Monitoring Committee.
The Clinical Pharmacology Quality Assurance and Quality Control Program is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The CPQA was charged to develop and conduct quality assurance activities for pharmacology laboratories that collaborate in NIAID-sponsored HIV/AIDS networks. The program includes a proficiency testing component to assure the accuracy of quantitative assays; oversight of new assay development, validation and implementation; and training and certification for clinical site and laboratory staff. Frontier Science has participated in all phases of the project and has primary responsibility for analytical, computing and laboratory data management support since the program's inception in 2007.
Frontier Science is a key collaborator with the European Thoracic Oncology Platform (ETOP). We provide biostatistical support from trial design through final analysis and reporting. ETOP is a foundation to promote the scientific exchange and research in the field of thoracic malignancies. It sponsors and manages translational research projects and clinical trials in Europe and beyond.