India has largest pool of patients for clinical trials

By: Trialmed editor

Aug 20, 2011

India these days has the largest pool of patients suffering from cancer, obesity, diabetes and metabolic syndrome is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials. India with its booming economy has both the diseases of the west and the diseases of the east.

Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities, especially Pune, Mumbai, Hydearbad and Ahmedabad and Bangalore. This is because India offers western trained doctors and english speaking patients for the most parts in the above mentioned cities.

Global consultancy McKinsey & Co estimated that by 2011, global pharma majors would spend around $1-1.5 billion just for drug trials in the country.

Data from the US government’s global trials registry, clinicaltrial.gov, show only 246 clinical trials were held in India in 2009. That was 9.6 per cent lower than the number of trials a year before. On the other hand, the number in China (316) and Korea (397) grew 15.3 per cent and 20.7 per cent, respectively, in 2009 as against the previous year.

If India has the patient population, as much of Latin America and EU combined. Why have the number of clinical trials dipped. The answer is the time lag in the regulatory approvals, once an easy approval process has become extremely bureaucratic process, by the time the study is approved, the investigators have lost interest in the study.

Investigators who are mostly key opinion leaders have very little time to follow the process laid out by the protocol, leading to protocol deviations and paucity of time to complete the documents.

CROs have played a big role in combating the above problems, but in doing so the competitive pricing is not available.

We still believe that the smaller CROs have more potential and time to offer to companies that can spend the time to work with the approval process, training of the doctors and the CRA with the protocol and study requirements. Helping CROs develop study information packets enables patient recruitment per protocol and keeps the enthusiasm of the study high.

CROs like TrialMed India www.trialmed.com are providing clinical trial support and marketing support to the early start ups who want to do clinical trials in India. They are also available for large medical device firms to market their medical devices in India.

FDA to relax regulations

By: Trialmed editor

Aug 19, 2011

Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products. Specifically, a number of device types will now be exempt from pre- market notification requirements. The FDA move, which affects approximately 30 medical device types ranging from radiology film processors to blood testing, was prompted by the long track record of safety and effectiveness of each respective product. CDRH Director Jeffrey Shuren stated that “the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers,” without risking the health of the public in the process. The FDA has also stated that this is the first step in what will be a gradual loosening of 510(k) requirements across the board for low-risk radiology and in vitro diagnostic devices. Until this occurs, the FDA will exercise what it calls “enforcement discretion” in handling pre-market notification submissions for the 30 medical device types described within the document. There is as of yet no timetable for the adoption of this dramatic shift in medical device regulatory approval standards, but a 90-day comment period on the proposal is currently in effect.