U.S. devicemakers face challenges in designing clinical trials, among them low recruitment rates and high costs. India may have the answer.
Among the benefits, Pacific Bridge Medical reports in their November 2006 newsletter that cost savings can reach 40 to 60 percent. India also offers a large, ethinically diverse population and increasing numbers of English-speaking physicians equipped to manage the trials.
Ethics and maintaing Good Clinical Practices (GCP) are a priority for trials based in India, where the regulatory environment is more lax than in the U.S. Informed consent, quality assurance and standards for data recording have not yet been formally regulated. However, steps are being taken to bring Indian trials up to U.S. standards; the country is in the process of developing a National Drug Authority, similar to the FDA, to regulate pharma trials and production. It follows that device regulation is next, and last July we saw sampling of new guidelines.
This trial migration isn't only pharma - device companies are starting to relocate some of their trials as well. Medtronic and Boston Scientific are beginning to conduct trials in India, and contract research organization (CRO) Alquest announced in September that they were the the first device-focused CRO in the industry to offer clinical support in India. If other companies follow suit, India will open the door to less expensive, faster trials that don't compromise clinical standards.
