Dr Saurendra Das,
country head and executive
director of operations, Excel Life Sciences, Uttar Pradesh
Das has over 12 years of experience in coordination of all phases of
global and domestic clinical trials. Prior to joining Excel Life
Sciences, Dr Das was responsible for establishing two major site
management organizations (SMOs), and one clinical research organization
(CRO) in India. He has led large clinical operations teams and brought
many innovations to the field, including strategies, systems and
processes, for faster enrollment and increased retention. As an active
trainer, he worked closely with faculties from the Harvard Medical
International for developing a global training program, and has
personally trained hundreds of pharma, CRO, SMO, central lab and site
employees. Dr Das has worked as faculty for the Central Drug Standard
Control Organization (CDSCO), World Health Organization (WHO) and
Institute of Clinical Research India (ICRI)
It is well-known that India is a region where clinical research is on
the rise. India has several advantages to its credit that include huge
population of treatment-näive patients and cost-efficient clinical
trials. It is rightly estimated that by 2010, the clinical research
market in India will reach
That growth brought a tremendous amount of regulatory restriction and
safety measures to protect the rights of patients. It has also
attracted a tremendous amount of scrutiny and negative media coverage.
However, not much information has been publicized regarding Indian
patient’s knowledge and understanding of clinical research and their
experiences, especially with the informed consent process.
Excel Life Sciences has recently conducted a survey of over 900 study
participants. This research brief analyzes the findings of the study,
and includes comparisons of the findings with the study conducted on US
patients by CenterWatch. This is also the first such survey to be made
Findings of the study
About 97.7 percent patients who participated in the survey understood
the informed consent form (70 percent very well, 27 percent well).
About 99 percent of patients came to know about the clinical study
through a physician, as against just 23 percent in the US.
Only nine percent of patients in India made the decision to participate
on their own, as compared to 38 percent in the US.
About 63 percent of patients were not aware of clinical research prior
to participating in a study.
The research brief comprises of proprietary data collected from the
2009 informed consent survey of Indian study volunteers, and data from
a 2005 US 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
Considering that India is still a nascent market for clinical research,
it is surprising to find that over 40 percent of the patients in the
survey, had some understanding about clinical research trials prior to
participating. Overall, patients seemed to have a strong understanding
of what was required of them in a study and the risks involved in it.
In general, the vast majority of patients, some 97 percent, understood
the informed consent document (70 percent very well, 27 percent
somewhat well). Specifically, patients had a strong understanding of
About 98 percent understood the number of times they would have to
visit the site.
About 95 percent understood that the study would carry risks and
The advent and expansion of the internet, along with
the litigious healthcare environment in the US, has caused many
patients to pursue a variety of information sources to make educated
healthcare decisions. In fact, US surveys have found that more than 60
percent of volunteers go outside of their managed-care setting to
self-refer into clinical trials. The Excel Life Sciences survey has
found there is a much more traditional information system in place in
India, where patients still turn to their physicians for information
about their health. In total, 97 percent of patients in the Excel Life
Sciences survey, first learned about the study through a physician,
including primary care (76 percent) or another physician (21 percent).
decision support system:
to survey findings, there is both a cultural and operational support
system in place in India, to assist patients with informed decision
Culturally, the role of the family and trust in their primary care
physician, play a very important role in a patient’s decision to
participate. Most patients travel with loved ones to visit doctor, and
the same is true for their clinical trial visits. Only nine percent of
volunteers made the decision to participate in the trial, by
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 the average study
retention rates are in the low-to-mid-90th percentile. Higher retention
rates allow studies to finish sooner, and help reduce study costs and
speed the development of new compounds.