This article features findings from an ongoing survey, which now includes more than 3,300 clinical trial volunteers. The first-of-its-kind survey aims to provide stakeholders in the clinical research enterprise in India with a better understanding of the experiences of clinical study volunteers who participate in the India arm of global studies.
It’s well known that India is a region of the world where clinical research is on the rise. There are many incentives for conducting research in India, including driving economic development in the country, involving clinicians in leading edge medicine, advancing science and potential treatment options for the people of India. For the drug development industry, there are a number of well-known advantages. In a recent report published by Booz & Co and BayBio looking at the current and projected outsourcing activities of BayBio member biopharmaceutical companies, China and India represented the top two countries where members expected to be conducting trials in the next 2-3 years. In fact, India has seen an average annual growth rate of +30% in ongoing trials over the past 7 years.
Along with opening new development pathways, treatment options and commercial opportunities, that growth has resulted in the rapid implementation of a tremendous amount of regulatory oversight and safety measures to protect the rights of patients. Naturally, it has also attracted scrutiny and negative media coverage. While pundits and proponents have used the press to make their position loud and clear, there has been a dearth of information regarding the actual experiences of Indian clinical trial study volunteers and the informed consent process.
Excel Life Sciences has been conducting an ongoing survey which now includes more than 3,300 study volunteers. The first-of-its-kind survey aims to provide stakeholders in the clinical research enterprise in India with a better understanding of the experiences of clinical study volunteers who participate in the India arm of global studies. This Excel Life Sciences research brief analyzes the findings of the survey and includes comparisons to similar surveys of U.S. patients conducted by CenterWatch and others.
Aggregated responses from the survey have shed new light on a topic which has been mostly covered through anecdotal data from public information and interviews. Specifically, the following key findings were uncovered:
Key Findings from Clinical Study Volunteers Survey in India
- 56% of volunteers were not aware of clinical research prior to participating
- 97% of volunteers understood the informed consent form (70% very well, 27% well)
- 97% of volunteers found out about the study through a physician, vs. 23% in the U.S.
- 8% of volunteers made the decision to participate on their own, vs. 38% in the U.S.
Method:
This research brief is comprised of proprietary data collected from the 2008-2012 Informed Consent survey of Indian study volunteers and data from a 2005 U.S. patient survey conducted by CenterWatch and publicized at the 2006 DIA Annual Meeting. Excel Life Sciences collected the survey data through clinical research coordinators supporting studies at active clinical research sites. Data was collected from July 2008 and the survey is ongoing.
Observations and Conclusions:
Better Than Expected Understanding
Considering that India is still a comparatively new market for clinical research, Excel Life Sciences was surprised to find that over 40% of patients had some understanding about clinical research trials prior to participating. Most patients though, lacked more than surface level awareness and understanding. Overall, patients seemed to have a strong understanding of what was required of them in a study and the risks of participating. In general, the vast majority of patients, some 97%, understood the informed consent document (70% very well, 27% somewhat well). Specifically, patients had a strong understanding of the following:
- 98% understood the number of times that they would have to visit the site
- 93% understood that the study would carry risks and discomforts
Traditional Health Information Sources Used by Volunteers
The advent and expansion of the Internet, along with the litigious healthcare environment in the United States has caused many patients to pursue a variety of information sources to make educated healthcare decisions. In fact, U.S. surveys have found that more than 60% of volunteers go outside of their managed-care setting to self-refer into clinical trials. The Excel Life Sciences survey has found that there is a much more traditional information system in place in India, where patients still turn to their physicians for information about their health and treatment options. In total 97% of patients in the Excel Life Sciences survey, first learned about the study through a physician, including primary care (76%) or another physician (21%).
Patients: Decision Support System is Strong
According to survey findings, there is both a cultural and operational support system in place in India assisting patients with making an informed decision:
- Culturally, the role of the family and trust in their primary care physician play a very important part in a patient’s decision to participate. Most patients travel with loved ones to doctor visits and the same is true for their clinical trial visits. Only 8% of volunteers made the decision to participate in the trial by themselves vs. 38% in the United States.
- Operationally, the sites involved in the survey had a dedicated highly trained clinical research coordinator working at the study site, assisting busy physicians with running the trial and helping to answer questions patients or their loved ones have about the study and informed consent form.
When considering this support system in India, it is interesting to note that Excel Life Sciences has found that average study retention rates are in the low to mid 90th percentile. In comparison, the United States and Western Europe historically see an average of 25% of trial volunteers drops out of trials before completion. Higher retention rates allow studies to finish sooner and help reduce study costs and speed the development of new compounds.
Study Authors:
Dr. Vijai Kumar, President and Chief Medical Officer - Excel Life Sciences,
Dr. Saurendra Das, Executive Director of Operations, India – Excel Life Sciences
Dan McDonald, Sr. Vice President-Business Strategy - Excel Life Sciences.
The study was last updated January 2013.
