Monday, November 3, 2008

India, China, Latin America and CEE as Clinical Trial Destinations

As part of our Partnerships with CROs LinkedIn group, we often share discussions regarding various aspects of the clinical outsourcing industry. I recently posted a specific question regarding new markets and their rise as destinations for outsourcing clinical trials. The question:
What are your thoughts on India, China, Latin America and CEE as clinical trial destinations in terms of capacity, resources and facilities? Received several excellent responses. I thought it would be great to share some of the responses with our readers:

Guy Bafort, Director Regional Clinical Operations CEET at Bristol-Myers Squibb:

R&D activities in the CEE region for example have been ongoing for more then a decade. What we do see over the last couple of years is a substantial uptake of R&D activities in all those countries. In CEET alone, this translates into an annual increase in the number of clinical trials with 25% to more then 50% on an annual basis over the last 3 years (data based on . The outcome is increased competition, not only for sites, investigators and patients, but also for resources. It is becoming increasingly more of a challenge to find experienced staff. In terms of facilities in CEET, it really depends, but the majority of sites fit the standards we need for our studies. Now that the competition for sites and investigators is increasing, companies and CROs are reaching however out to less experienced sites in more remote regions of the larger countries within the region.

Mahalingam Vasudevan, President , Roxanne Research:
Human Resource: India has substantial capacity to meet the rapidly growing demand for clinical trials. India has 300 universities, over 750 graduate and post-graduate programs, and about 50 million college graduates. There are over 700,000 medical professionals and over 600 ICH/GCP compliant sites. Large pool of specialist clinical investigators who are GCP-trained and compliant, and who have participated in numerous international clinical trials

Patients Resource : India has the largest pool of patients suffering from cancer, diabetes and other maladies is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials. Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities ( Eli Lilly / Pfizer / Roche /.. ). The overall impression is that the data quality is usually excellent with Genuine CROs.

Advantage of India : Patient diversity / Patient heterogeneity/ World class medical infrastructure/ Familiarity with western medical facilities/ English competency / Cost competency ( patient recruitment, shorter timelines,manpower etc.,) / ICH / GCP guidelines implementation / Project management competencies / Central lab facilities ( Internationally, nationally accredited)/ Regulatory guidelines and government policies – helping clinical research in India ( MOH, DCGI, ICMR, DBT etc.,) / and also
* “Western” disease distribution
* High patient numbers available
* Many tertiary care and specialty hospitals
* Large number of medical specialists
* Patients generally “therapy na├»ve”
* Low cost
* No language barriers
* IT-based advantages

Quality in Trials : Although the US FDA has yet to inspect any clinical trials in India, most sponsors and CROs carry out their own audits of clinical trials. Numerous audits in India are a testimony to the level of quality. Data from clinical studies in India have been successfully filed with international regulatory quality is the hallmark of global acceptance, most sponsors and CROs invest heavily in monitoring, quality control and investigator training.

Srirupa Pal, Vice President, Roxaane Research:

The outsourcing of drug discovery research to India is on the rise. According to research firm Frost & Sullivan, the Pharma outsourcing business in India will grow to around $7 billion by 2013. In 2006, they had estimated value of the Indian Contract Research and Manufacturing Services (CRAMS) market as $895 million.This above mentioned statistical analysis reflects the extent of growth the CRO industry is currently experiencing and its bright future prospects.

Another report by Pune-based research firm Value Notes, forecasts a growth of 23.6 percent annually for the industry up to 2010. Presently, India conducts about 1.5 percent of the Global Clinical Trials. This could rise to 5 percent by 2008 and 15 percent by 2011. And that is the percentage of a global trial that itself is increasing by 10 percent every year.

All of these and several more on LinkedIn raise some excellent insights into the state of these markets as destinations for CROs. I invite anyone else with their own perspectives to please add them here as a comment or on our LinkedIn group.

1 comment:

Oliver Halsby said...

The articles were very enlightening, it would be interesting to see peoples' views on how the recent recessionary / depressionary forecasts will effect the attractivity of these destinations..