Quintiles Transnational’s customers will gain access to Clinical Data’s (CLDA) services related to the evaluation of drug-induced QT prolongation, according to a strategic alliance formed between the two companies. Quintiles and CLDA may also collaborate on the study of drug-induced QT prolongation for potential development of new products or services.
This multiyear agreement will help sponsors and regulatory agencies further the understanding of the contribution of genetics to the QT-prolonging effects of drugs. "Thorough QT (TQT) studies are designed to demonstrate the propensity of new molecular entities to cause prolongation of the QT interval on the ECG,” explains Carol R. Reed, M.D., senior vp and CMO. “This partnership will offer sponsors a unique spectrum of services to evaluate the contribution of genetics to QT prolongation and to comply with the recommendations of ICH guidelines, which encourage genetic testing in conjunction with TQT trials."
"We believe that integration of genotype testing is essential to safety evaluation of molecules under development,” comments Dhiraj Narula, M.D., medical director of Quintiles ECG Services. “Genotype testing holds great promise in helping us select or exclude subjects from clinical trials and in advancing our understanding of the genetic correlates of drug toxicity. It may also help revive the development of useful molecules with undesired effects on repolarization by serving as a screening test for eligibility for therapy."