OHRP Should Investigate Novartis Trials, Group Says

The Office of Human Research Protection (OHRP) has received a letter from the advocacy group Public Citizen requesting that the agency conduct a compliance oversight evaluation of any U.S. institutions involved in six Phase III studies of indacaterol maleate, Novartis’ investigational chronic obstructive pulmonary disease (COPD) treatment. The trials in question evaluated indacaterol, a long-acting β-adrenergic agonist, against placebo in 12- and 26-week efficacy studies.
Clinical Trials Advisor