Opportunities in the Clinic
Speakers at the meeting stated that India, Russia, and Brazil all offered good clinical trials facilities at a fraction of the cost of using most European trial centers. Ivan Petyaev, Ph.D., chief medical and scientific officer at Cambridge Theranostics (www.cambridgetheranostics.com), said, “Russia has undergone a transformation in the past decade with many of the hospitals now equipped to Western standards. In fact, we have had our Phase II trials in Russia independently audited, and since they met the required standard we will have no qualms about using Russian hospitals for trial work again.”
The cheaper cost of running trials is not the only reason for outsourcing to India or Brazil. “In India there are many cancer patients who are not treated, making the evaluation of an investigational medicine more robust as there are no drug wash-out effects. Also the incidence of cancers types is different, and we have been able to evaluate treatments on large patient populations, which would not be possible or very difficult in the U.S. and Europe. And, of course, if successful these medicines will bring particular benefit to the broader population in India,” Dr. Skingle commented.
“In Brazil there are 180 million drug-naive patients, so patient recruitment is much more rapid than in Europe and the U.S.,” Anderson added.
All the speakers agreed that only some clinical trials centers in these countries are working to the correct regulatory standards. “Brazil is a large country with some very poor areas so you have to choose centers for trials carefully as many public hospitals are deficient,” warned Anderson.
“Many hospitals in India do not yet operate to GCP standards but centers in London, Oxford, and Cambridge are now brokering relationships with Indian hospitals to share best practice because they realize there is an untapped source of patients,” Dr. Skingle said.
A more worrying problem is potential patient exploitation. “There is an issue in India about informed consent and whether clinicians are making it clear to patients what they are signing up for. But again there is debate about this, and soon there will be more government input to make the legislation clear in India,” added Dr. Skingle.