Quintiles, PPD Lead List of CROs with Approved Global Trials in India

21-Jul-2013 - Last updated on 22-Jul-2013 at 11:11 GMT

Despite questions over India’s regulations governing clinical trials, the largest CROs in the world do not seem deterred from running trials there, according to a recently released list of global trial approvals from 2012.

Overall most of the CROs’ trial protocols called for only a small portion of the total enrolled patients to be from India. And nearly all were Phase II, IIb and III trials, while 103 of 145 trials were for small molecule drugs and only 42 were for biologics.

The detailed list of the 145 global trials was released by CDSCO (Central Drugs Standards Control Organization), which simultaneously claims to have approved 262 clinical trials in 2012. Most of the trials’ protocols called for only a small portion of the total enrolled patients to be from India.

Quintiles led the way among CROs listed with ten different trials approved, with four of those as potential treatments for various forms of schizophrenia. The other potential treatments look to address adenoviral conjunctivitis, metastatic medullary thyroid carcinoma, treatment-resistant partial onset seizures, cardiovascular events in adults with stable coronary heart disease, renal cell carcinoma and Type 3 Gaucher disease.

PPD followed Quintiles with five approved trials for potential drugs, including one biologic, for a wide variety of conditions. The trials aim to treat complicated intra-abdominal infections, neurogenic detrusor overactivity, tonic-clonic seizures, antiretroviral-naive patients with HIV-1 and advanced stage follicular lymphoma.

Following close behind PPD was Covance, which received four trial approvals, including two for Tourette's syndrome and two others to treat high cholesterol. PRA, InVentiv, Medpace, Parexel, Novotech, Pharmanet, Sristek, KlinEra and Clintec also were among the global CROs with trials approved in India.

Local Indian CROs

Max Neeman led all local Indian CROs, with six trials approved, including four for potential biologics, though all of their trials were only enrolling patients in India.

The release of the list of trial approvals by CDSCO comes as some in the research community and India’s Supreme Court are calling for more transparency.

John Lewis, VP of public affairs at ACRO (Association of Clinical Research Organization), told us recently that India is “shrouded in regulatory uncertainty” and until it improves, “activity is likely to be very limited.”