Clinical Research: Issues and Opportunities

Clinical research is an indispensable part of the drug discovery process to ensure the safety and efficacy of any new drug. In today’s global scientific era, clinical trials are the mainstay for bringing newer and better drugs to market. Although a set of robust guidelines is available to govern the conduct of clinical trials in any country, the conduct of clinical research is also looked upon as an area of humanitarian concern. Various articles published recently in the professional and popular press enumerate the opportunities and challenges of conducting global clinical trials
in India.However, the majority have been from the perspective of authors who have never conducted clinical trials in India themselves.
A nation with more than 1 billion people, India has the second largest population in the world.Having gained its independence from British rule in 1947, its prime minister is the head of government and its president is the head of state. Internationally, India became a member of the World Trade Organization (WTO) in 1995 and agreed to adhere to the product patent regime by 2005. As a result, the global pharmaceutical industry has the rights to patent products as well as processes throughout the world, including India. This has led to a significant
growth of the pharmaceutical industry, both domestically in India and globally, including increased stakes of multinational companies in Indian operations. As a signatory to the WTO agreements, India is looked upon as a favorable destination for conducting global clinical trials. India clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, a wide spectrum of disease, lower costs of operations, and a favorable economic and intellectual property environment. The overall time and cost advantage in bringing a drug to market by leveraging India’s resources could be as high as US $200 million, hence the steadily
increasing number of global studies in India over the past two years. Major pharmaceutical companies estimate the total market for conducting clinical trials either directly or through contract research organizations (CROs) in India through 2010 at US $2 billion. CROs themselves are fast gaining importance because of their global presence, specialized local expertise, and competitive pricing strategies. And a significant number of new CROs have set up operations
in India over the past two years. However, some key barriers stand in the way of opportunities, including patients’ rights and safety, regulatory framework, infrastructure, organization of ethics committees, data quality, lack of training curricula focusing on clinical research, and other factors.Most of these barriers are common to all developing countries and need to be addressed in a similar way.
Because the clinical investigator plays a major role in the ethical conduct of any clinical trial, its successful outcome depends on how the investigator(s) has assumed overall responsibility. Most of the barriers mentioned above can be easily addressed if a clinical investigator is
committed to the ethical conduct of trials.
A segment of ideologues in India believe that clinical trials conduct poses a serious threat to society because of issues related to patient rights and safety, regulatory compliance, unethical trials, infrastructure and training issues, and exorbitant drug pricing. These threats are perceptions, not reality.
A well-designed and executed study has built-in provisions to ensure patient rights and safety.In fact, a patient may be far safer in a clinical trial than in routine medical care because careful
observations are made on safety (toxicity) and efficacy.
Although it typically takes 10 to 12 years and millions of dollars to bring one new drug to market, the success rate is small
In the developing world, no company or institute wants to, or can, invest such time and resources for a marginal improvement in responses over existing therapies. Fortunately, in a majority of cases, clinical trials can provide answers regarding the use or not of a therapeutic
agent that can benefit millions of patients worldwide. Being the second most populated country in the world, India can contribute significantly to global drug development programs.
The foundation of knowledge-based industries in India was laid down by the information technology industry, and there is no reason why clinical research cannot follow in those footsteps. Indian investigators and clinical research professionals have already demonstrated their
medical and scientific skills by participating in multiple global clinical trials. It
is time now to move forward to capitalize on the opportunity.