Cutting Edge Information Investigates Whether Registration of Trials in India Is Positive Development for Pharmaceutical Companies

RESEARCH TRIANGLE PARK, NC--(Marketwire - May 11, 2009) - Beginning in June, all clinical trials conducted in India must be registered with the Indian Council of Medical Research, and the information will be publicly available. This change -- which alters the previous system of voluntary, confidential registration -- follows the deaths of 49 infants in clinical trials at one of India's top hospitals. It may signal changes in the laxity of Indian clinical trial regulations in comparison to more developed countries.

While regulation is not generally welcomed by industry, the world's pharmaceutical and biotechnology companies stand to benefit from increased oversight in India.

"A child died recently in a Prevnar trial, and the entire trial had to be halted," says Jeremy Spivey, Cutting Edge Information research analyst and lead writer of "Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships." "The infant's death was likely due to her poor state of health before she entered the trial. Nonetheless, her death compromised the trial."

As India becomes more regulated, unhealthy trial participants will be screened out unless a drug is specifically designed to treat the participant's illness. "This is not only a more ethical way of conducting a trial," Spivey notes, "but it also prevents trial terminations and the reputation damage that comes along with them."

Under-regulation of clinical trials is a serious issue, but it is far from the only one affecting decisions to outsource trials to India. Participants in the newly released Cutting Edge Information report also point to infrastructure deficits and poor communication with participants that cause frustration for pharmaceutical companies.

"Despite these deficits, India is an extremely popular place to outsource clinical trials," says Spivey, "and it's likely to become even more so as these problems are addressed."

Cutting Edge Information's "Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships" (http://www.clinicaloutsourcingstrategy.com) discusses benefits and drawbacks of specific regions when outsourcing trials. The report examines clinical outsourcing trends and provides strategies for eliminating common obstacles in CRO selection and management. It also shows trial sponsors how to formulate a proactive outsourcing strategy, establish criteria for selecting a vendor, and manage day-to-day CRO relationships.

A complimentary report brochure is available at http://www.clinicaloutsourcingstrategy.com.

Contact Information: Contact: Jeremy Spivey 919-433-0373