Clinical Trials Policies
We’ve made the commitment to conduct clinical trials only in countries where we intend to later market and provide access to the compounds.
These trials also enable health care institutions in these countries to strengthen their own capabilities to run advanced clinical trials that meet both local and global registrational standards. We provide experimental drugs without charge to clinical trial study participants for as long as their physicians require them.
Focus on Pediatric Formulations: Currently pediatric formulations for all existing Bristol Myers Squibb anti-virals for HIV exist or are in development. Plans are also underway to develop pediatric formulations for investigational compounds for the treatment of hepatitis B and C. Oncology, cardiovascular and diabetes pediatric formulation activities are also ongoing.
Sickle Cell Anemia: We’ve provided data to the National Institutes of Health for an Investigational New Drug Application (IND) to be filed to develop a childhood formulation and pediatric indication of the company’s hydroxyurea compound for sickle cell anemia.
Regional Clinical Operations (RCO) India: This center, which opened in 2006 with one researcher, now has 22 active R&D clinical personnel. It has organized 43 clinical trials in India enrolling some 4,400 patients. The majority of these studies are registrational trials for various oncology, diabetes, cardiovascular, hepatitis and immunoscience drugs addressing disease areas of concern within India.
Clinical Trial Growth: We invest in R&D in many developing countries to provide innovative, high-quality medicines that address the unmet medical needs of patients with serious diseases. For example, from 2008 through 2013 we had studies ongoing in the following countries: