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.

A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world till a while ago.
But these days the fact that 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, especially Hydearbad and Ahmedabad [ Images ].
Global consultancy McKinsey & Co estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country.
So these days, Dr Vishwanath Reddy, a pharmaceutical consultant based in Hyderabad, is getting a steady stream of visitors. He says he gets at least one business call a week from a foreign company eager to set up clinical trials facility in India.
"The world is simply attracted by the facilities that India offers for pharma companies, their product developments and trials. The biggest advantages many look at are, of course, India's huge population of more than one billion, and cheaper costs," Dr Reddy points out.
Dr Reddy dishes out a study by Rabo India Finance, a subsidiary of the Netherlands-based Rabo Bank, to emphasise that India is the ideal destination for clinical trials.
The report says that India has the largest pool of patients with many diseases, including cancer and diabetes.
Pharma giants are also magnetized by India due to the fact that the country offers nearly 700,000 speciality hospital beds, 221 medical colleges and skilled English-speaking medical personnel.
The Rabo study, however, pinpoints that the biggest advantage is the low cost.
For instance, trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at a 60 per cent reduction of that whopping cost.
India's drug industry officials say the clinical-trials outsourcing has just begun in the country.
According to a Confederation of Indian Industry study, clinical trials in India in 2002 generated $70 million in revenues.
It predicts that it would grow to $200 million by 2007 and anywhere between $500 million and $1 billion by 2010.
So today all big global pharma names like Novo Nordisk, Aventis [ Get Quote ], Novartis [ Get Quote ], GlaxoSmithKline [ Get Quote ], Eli Lilly and Pfizer [ Get Quote ] have begun clinical drug trials across various Indian cities.
The pace for drug trials in the country is so fast that the Clinical Data Interchange Standards Consortium (CDISC), USA, a non-profit organization committed to the development of clinical research organizations' standards the world over, is looking at setting up its chapter in India.
CDISC is an open, multidisciplinary, organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.
The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in the industry.
So which are the pharma majors that are into breakthrough clinical trials in India?
Here are some of them:
Eli Lilly: The global pharmaceutical giant has 17 large and small clinical research projects running in 40 hospitals across India.
The company's clinical trials are to test if Xigris, which is indicated for reduction of mortality in adult patients, can be used for sepsis. Eli Lilly has already held clinical trials involving more than 600 patients for Human Insulin and Insulin Lispro. It is also these days conducting trials on oncology, and developing a new molecule for lung cancer.
Pfizer: The pharma giant has picked up six cities in the northeastern states of India to conduct clinical trials on 300 patients on a new malaria 'cocktail' drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic.
Pfizer is also carrying out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia. Pfizer's cumulative investment on clinical research in India is believed to be $13 million.
Roche: The Swiss pharma major has set up clinical trial sites in India as part of its global trials for treatment of a particular variant of lung cancer. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products.
India is also being considered a prospective site for Roche's future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.
SIRO Clinpharm: SIRO is currently conducting clinical trial projects in over 30 hospitals across the country for several clients from Europe, Japan [ Images ], the United States and also India.
The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, pediatric diseases and infectious diseases.
Clinigene International: The Bangalore-based Clinigene says India's huge population allows new-drug studies to be completed much faster. Last year, when a biotechnology company from the US needed 400 diabetics for a study, Clinigene began by heading to a nearby hospital specialising in diabetes, where a dozen new patients arrive every day and more than 40,000 are in its records.
Wellquest: Wellquest, the clinical trials division of the Nicholas Piramal [ Get Quote ] Group, is conducting 40 drug product tests in five cities across the country. The company has 75 beds for patients on whom clinical trials are being carried out.
Even as the clinical outsourcing boom is beginning to explode, the Indian government is all set to further boost it.
Officials in the health ministry said that the government might now consider giving permissions to pharmaceutical companies to conduct simultaneous trials in India and overseas.