The Hindu Business Line : `Clinical studies are subject to very strict rules and guidelines'

After services, semiconductors and auto components, outsourcing is now throwing up new revenue opportunities for India. And clinical research is one of the fastest-growing areas for multinational drug companies seeking to cut costs without sacrificing quality.

The country has emerged as a magnet for this sector mainly due to low costs, R&D personnel, capital and operations and international-standard infrastructure, said Dr S.K. Gupta, Dean of the Institute of Clinical Research (India) or ICRI.

Speaking to Business Line on the potential of outsourcing clinical research, he said a number of factors favour the recognition of India as a clinical research hub.

Clinical trials account for 65 per cent of expenditure involved in drug development, with new drug discovery accounting for the rest.

"India works out to be a cheaper option as the cost of conducting a trial is lower by 50-75 per cent, than the US or the European Union," said Dr Gupta. "Clinical trials cost about Rs 1,200 crore abroad ($300-350 million), but only about Rs 100 crore in India." It is possible to conduct both new drug discovery research and novel drug delivery system programmes at competitive rates, he added.

Besides, there are numerous Government-funded medical and pharmaceutical institutions with modern facilities that serve as ideal centres for multi-centred clinical trials. India also boasts of a large constituency of well-trained and qualified manpower.

Moreover, studies can be completed sooner as there is a good communication link favouring fast recruitment and approval, according to Dr Gupta. This helps companies gain an edge over competitors.

Looking to India

Another reason why foreign firms are looking to shift trials to India is the high incidence of disorders and illnesses. According to reports, there are millions of people in India who suffer from asthma, diabetes, cancer, epilepsy, HIV, Alzheimer's disease, hypertension and schizophrenia.

The ICRI Dean also said that the rapidly evolving skill sets of Indian companies in basic R&D have narrowed the gap required for new chemical entity research. "This is one of the key reasons behind Western companies opting to outsource value-added research services to India."

Research in 4 phases

Clinical research is conducted in four phases. The process begins with a new drug being administered to a small number of healthy, informed volunteers to determine the effect of the compound. In subsequent phases, it is administered to bigger groups of patients after which the data is presented to the authorities for a commercial licence.

The last phase involves monitoring the effects on thousands of patients after doctors are allowed to prescribe it.

Though definitive information on the number of clinical trials going on in India is not available in the public domain, Dr Gupta said that reports suggest some 264 clinical trials are being conducted in the country.

One of the most common questions concerning clinical trials is how safe they are for patients. Dwelling on the common misconceptions surrounding clinical trials, Dr Gupta said a clinical trial is a carefully designed study that closely monitors the progress of a patient as he/she proceeds through treatment with a new drug. "Only patients who meet certain criteria may participate in a trial," he pointed out.

"Other misconceptions that patients have are that they won't get the best treatment if they participate, or that they will get a placebo and be treated like guinea pigs."

Dispelling the common notion that participants are often lured into such trials without being informed about the treatment, Dr Gupta said that all patients are fully informed about everything in the study - risks and benefits - before they take the decision to participate.

"Besides, clinical studies are subject to very strict rules and guidelines and are evaluated very carefully before they are even started. They also have to be vetted by an ethics committee."

He urged the need to remove such mental roadblocks. "Patients need to know that in most cases they will be getting as good or better care than standard therapy, that a placebo is never used in cancer treatment. Also, in most cases treatment is covered by insurance."

He believes that physicians must spend enough time with their patients to ensure that misconceptions and inadequate information don't stand in the way of determining for themselves whether a clinical trial is in their best interests.

According to him, only 46 per cent of physicians/investigators recognise that the main reason for clinical trials is benefit to future patients.

"After all, many physicians encourage patients to enrol in these trials because they believe a trial offers them the best therapeutic option at that point."

Also, a third of providers are uncertain whether clinical trials always use non-standard treatments or procedures, whether the treatments assessed are by definition unproven and whether the trials involve some incremental risk or discomfort.

Dr Gupta said that the laws governing clinical trials have improved a great deal. "In these laws, the safety of the patients is never compromised. There have been major changes in rules and regulations after many disasters, such as the Thalidomide disaster."

He added that the current laws are stringent now but one can comply with them. "This has increased the cost of drug development, but this is acceptable since safety is the prime concern."

Recently, Pfizer received a setback after it had to discontinue trials of a late-stage cholesterol-lowering drug due to safety problems.

According to Dr Gupta, the setback will not cast any shadow on ongoing clinical research. "These setbacks are normally seen. It shows that the regulatory agencies are well in place and they are concerned about the safety of patients."

Elaborating on the insurance cover for trial volunteers, he said that typically, when a patient enrols, the costs of tests, procedures, drugs and any research activity directly associated with the investigation are covered by the group sponsoring the trial, such as a pharmaceutical company or the National Cancer Institute.

"However, because some health plans define clinical trials as `experimental' or `investigational,' health insurance coverage may not include some or all of the costs of routine patient care."

Patient Confidentiality

On the level of transparency, he said that the identity of a patient is confidential and can only be revealed to regulatory agencies or an ethics committee.

Dr Gupta admitted that the risk of unpleasant or even dangerous side effects does exist, "but the risk is usually very low and is always explained in full. Patients should always feel free to ask any questions and expect to receive a clear answer to their full satisfaction."

Before starting a trial, patients are required to sign an informed consent form that explains what happens during the trial and the known risks and benefits of participating in it.

Dr Gupta informed that researchers are not allowed to pressure the patients into signing up for a trial. "Also, patients reserve the right to leave a trial at any time."

On the issue of payment to undergo the trials, he said most clinical research companies provide compensation to volunteers for the time spent and reimburse them for any inconvenience and travel expenses incurred along the way.

"Usually, Phase I clinical trials will pay you while others will not. The total amount you can receive as a healthy volunteer could be as little as £20 or well over £2,000."

In conclusion, Dr Gupta quoted from a new report, saying that pharmaceutical and biotechnology-based revenues for India's contract research industry are set to grow by more than 20 per cent each year in the near future, reaching $175 million by 2010 from $75 million currently.

Prior to his current responsibility, Dr Gupta was Head of Department of Pharmacology, AIIMS and is a former President of the Indian Pharmacological Society.

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