Frontier Science manages and analyzes 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.
The Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) is an initiative of the National Institute of Drug Abuse (NIDA) to facilitate collaboration between investigators and its longitudinal HIV/AIDS cohorts. C3PNO is managed by UCLA and Frontier Science. The project has assembled a team of researchers with global leadership in HIV prevention, clinical science and co-morbidities, behavioral science, immunology, modeling, and bioethics. C3PNO works with NIDA program scientists to align and stimulate the highest impact science across NIDA-funded cohorts.
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 serves as the Data Management and Reporting Unit for the National Cancer Institute Division of Cancer Prevention Cancer Prevention Clinical Trials Network (NCI DCP CP-CTNet). The purpose of CP-CTNet is to perform early phase (0-2) clinical trials to evaluate the biologic effects of preventive agents and interventions and to determine clinically-relevant correlates in order to advance their development for cancer prevention. Frontier Science provides data management, reporting, randomization, and site support services, as well as the creation of project-specific software systems. In addition to these activities, Frontier Science works with the Administrative and Coordinating Unit in a partnership with the University of Wisconsin to perform site auditing.
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.
IBCSG is one of the world's leading groups in breast cancer research, conducting clinical trials in early and advanced stage disease, including hormonal and chemotherapy, adjuvant and neoadjuvant therapy, immunotherapy, and tailored treatment. IBCSG additionally conducts extensive programs in translational research, database studies, quality of life, and statistical methodology. Frontier Science and the Dana Farber Cancer Institute serve as the Statistical and Data Management Center for IBCSG, supporting the work of the group in data management, trial coordination, statistical methodology and analyses, reporting, randomization, auditing, site support, and custom software systems.
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.
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.
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.