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Clinical Trials: How to get things right?

The issue of Clinical Trials in India has once again come to the fore with the government’s efforts to woo the mighty pharma industry. The Drug Controller General of India, Mr G N Singh, has been quoted as saying that India will soon roll out a new policy to facilitate clinical trials. It is hence important to understand what are we talking about and why we need to get it right.

Dr Kamal Mahawar
Dr Kamal Mahawar

Why do we need Clinical Trials?

Clinical trials, or testing a new treatment or drug on a few informed people, before it can be applied on a large scale is largely how modern evidence based medicine works. The results of these clinical trials then inform the development of clinical guidelines and routine medical decisions taken by doctors on a day-to-day basis. Without clinical trials, all progress in medical science will come to a halt and we will not be able to develop new treatments or drugs. Given that the environment we live in is continually changing and the microbes that account for a large part of the disease and suffering in developing country such as ours are forever adapting, our inability to develop newer treatments will pose a material risk to our existence. It will truly put our survival at risk and therefore it is important that clinical trials take place.

Need to Get it Right

A typical clinical trial will start with a scientific question that has a reasonable proof of concept. The question can be posed by anybody in the society – individuals, doctors, researchers, and even industry. We call this scientific curiosity and it is not restricted by anything. Anybody anywhere can have a genuine question. What happens next is important to understand though. To be able to test your hypothesis, you need funding and resources. Depending on the treatment proposed, you might even need to perform some animal experiments and finally conduct trials on human volunteers. All this takes money and time. Depending on the type of treatment, money could come from the industry, the government, or non-governmental organisations. When industry spends money on such projects, it is typically associated with an expectation that they will have exclusive rights to the new treatment or product for a number of years to recover their investment and also make some reasonable profits. Other organisations expect that the findings of such trials make a material difference to the quality of the health of the people. These organisations typically want to see that the research is published in recognised scientific journals so that other doctors can use the findings in their clinical practice.

I hope you can see clearly the difference in expectations from a clinical trial that is funded by the industry and other bodies. Whereas industry wants to recover its financial investment from the exercise, others usually have more noble aspirations. The industry has a vested interest in ensuring that their treatment comes out in a favourable light and that all negative outcomes are hidden. Not only that, if the trial findings are not encouraging, they are not obliged to make it public. They can simply go on funding more trials until one shows a positive result for the product and that one trial will be systematically blown out of proportion. All statisticians know that if you conduct enough number of tests, it is not impossible to find instances of false results appearing to be true. Data does not lie though and if anybody has access to all the records, they will see the truth easily. The problem is that most of us do not have access to the full set of data; we only have access to what is published. So if you thought published scientific research represents the truth, the full picture; think again. It is at best a selective portrayal of what the stakeholders want you to see and many doctors collaborate with the industry in this process.

The Volunteers

Clinical trials need human volunteers. Sometimes these are individuals with a particular disease or condition, who stand to benefit from these trials. These can even be perfectly healthy individuals with no disease. It is important to understand the motive of these volunteers for helping with clinical trials to understand the full picture. It would be understandable if you have an incurable illness that you would want to try a new drug or disease that a group of scientists or doctors believe might improve your chances. But as a patient, you can never know that the new treatment has reasonable chance to improve your health i.e., has an established proof of concept. For this purpose, we have ethics committees comprising of respectable people whose job it is to ensure that the question has enough basis to be scientifically tested. It is the responsibility of ethics committees to check that the potential for benefit is much higher and that all precautions have been taken to minimise harm. It is also their responsibility that all trial participants are fully informed of the risks involved and that there is adequate compensation in place for when things go wrong.

Why would a perfectly healthy person want to take part in a clinical trial with potential for risk? It is not impossible to comprehend this. Though there are some really generous souls out there, who would do it out of the goodness of their heart, more usually and especially in the case of developing and poor countries like India, volunteers are recruited through financial incentive. Such is the level of poverty in our country that people will sign on any paper and take any tablet their doctor gives them for a few hundred rupees. This has meant that the industry, with the help of their local collaborators, has been able to conduct trials that they wouldn’t be able to elsewhere and without the safeguards that other countries would insist upon. This is the reason clinical trials in India have attracted bad publicity in the past. There have been instances of trials on unsuspecting, gullible public, often with the collusion of doctors, without adequate consenting, and mechanisms to protect the health and the financial well-being of the volunteers and their families. That is probably why the government wants to get it right this time and one can only applaud their efforts for it.

The Safeguards

Most of the mechanism to ensure that clinical trials are conducted ethically already exist in the western world and we could generally adopt things from them to prevent the mighty pharmaceutical industry from exploiting the poor people in poor countries especially when they openly declare that they manufacture drugs for wealthy westerners and not for poor Indians (Google for comment by Bayer’s former CEO Marijn Dekkers if you don’t believe me!)

But we don’t have to just follow the rules laid down by other countries. We could come up with our own. First and the foremost that I would like to see is that the participants are fully informed of the risks in their own language in presence of somebody responsible who can countersign to say that the patient/volunteer understands everything written. In cases of unfortunate and unforeseen accidents, and one understands that they might well happen despite all precautions, researchers and ethics committees should be asked to explain their position and the sufferer and/or his family offered adequate financial settlement (which should be reasonably big so that it might prove to be a deterrent for the industry to avoid any loopholes next time).

The second important safeguard is for the general benefit as we are all at risk if we allow trials with negative results to go unpublished. For this, all approved trials must be registered with Clinical Trials Registry-India (CTRI), and efforts made to ensure that the findings are in public domain on the completion of the trial. If for some reason, a trial is not concluded, researchers should be asked to provide a statement on why that was the case and why they should not be prevented from conducting any trials in the future?

Lastly, and this is to do more with issues of personal and national pride. I am not comfortable with the tag that just because Indians are poor they can be experimented upon for the drugs and devices aimed at western market. I think the government should insist that the drugs trialled largely in India should also be manufactured in India and made available to Indian public at reasonable rates. This may even be good for government’s “Make in India” drive. The reverse proposal that a drug or device needs to be trialled on Indian population before it can be sold in India would be somewhat more difficult to implement and I believe can be implemented on a product to product basis rather than a blanket rule.

The list above is not exhaustive and I am sure people far wiser than me and with more direct experience of such matters will be able to suggest a few more ideas. But there is no reason why India cannot lead the world in setting up a process for clinical trials that is fair as well as futuristic. In the long run, the industry would also benefit from such a deep relationship based on mutual respect and need.

Following his graduation from Calcutta Medical College and post graduation from Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, Dr Kamal Mahawar is now a Consultant General and Bariatric Surgeon with Sunderland Royal Hospital in the United Kingdom. He is also an Associate Clinical Lecturer with Newcastle University and editor of renowned scientific journals. His recent book ‘The Ethical Doctor’ published by Harper Collins India examines some of the serious issues affecting Indian healthcare.

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