HIV Experts Propose New Pathway for Conducting Phase 3 Drug Trials
New Approach Intended to Remove Barriers to Innovation in Drug Development
WASHINGTON, DC (February 7, 2012) – As the war on HIV/AIDS begins its fourth decade, medical researchers, pharmaceutical manufacturers, patient advocates and government regulators face a new and unexpected scientific challenge: how to demonstrate the safety and efficacy of promising new antiretroviral drugs when the two traditional study designs – the superiority trial and the non-inferiority trial – are no longer useful in showing improvements in both “treatment experienced” patients and those who have never received drug therapy (treatment-naïve patients).