The clinical development sector in India engaged in global clinical trials for product registration with international regulatory
bodies is fast approaching an inflection point. Following a period when hype exceeded actual trial activity, the sector is
expected to accrue revenues of about $150 million USD in 2006, continue enjoying a 25% to 30% annual growth rate, and perhaps
even hit the much quoted $1 billion USD annual revenue target by 2010.1
Continued streamlining of the regulatory approval processes and the government's apparent commitment to enforce intellectual
property protection to international standards has addressed two key sponsor concerns. Global CROs and multinational pharmaceutical
companies are briskly building clinical operations capabilities in India. Consequently, recruiting resources able to meet
the demands of the heightened clinical trial activity in India is a challenge, as demand outstrips supply.
Numerous state- and industry-sponsored training initiatives are attempting to address this resourcing challenge with a degree
of success. The expectation is that as India's vast and growing pool of biomedical graduates completes clinical research training
programs and obtains clinical operations experience, the crunch will get ameliorated. However, resourcing and capacity constraints
at investigative sites could prove to be a more thorny issue. This article discusses the role investigative sites play in
enabling the Indian clinical development sector to attain its ambitions and explores effective approaches to building sustainable
working relationships with them. Importance of investigators
Sponsors and CROs universally recognize the value of investigators who are able to recruit patients and provide quality clinical
data in a timely fashion. They also recognize it is rare for the patient's physician, clinical investigator, and key opinion
leader to be the same individual, and they strive to reach out to each of these groups.
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In India's relatively nascent trial environment, investigators not only enable access to the large number of potential trial
participants—the fundamental attraction to India—but they also are custodians of the data's scientific and ethical integrity.
Obtaining data of the quality required to meet international regulatory standards and compliance with the spirit of GCP ethics,
in particular the informed consent process, remains a concern for sponsors and CROs. The investigator and site staff play
a key role in ensuring that patients are recruited, protocol is followed, and data is reported in accordance with the sponsor's
expectations. Although universally true, this is much more relevant in a country like India with its limited track record
of global clinical trial participation.
Investigator recruitment challenges
Investigator selection is the first and perhaps most important step toward building a pool of high-quality investigators.
India has over 500,000 qualified doctors, with 17,000 physicians graduating each year from the country's 210 medical colleges.2 Medical training is delivered in English and based on a curriculum that incorporates all of the elements of the Western
medical system. India's leading specialists, with appointments at leading state and private hospitals, often have received
part of their postgraduate training in either the UK or the United States.
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The vastness of the Indian medical education system with its many physicians and medical institutions poses a challenge because
of the tremendous variation in the quality of training. Due to different governance structures, levels of state subsidy, and
student motivation there are notable differences in the quality of training, research, and health care delivered at India's
medical colleges.
