Clinical trials: Breaking the taboo

India’s share of global clinical trials, minuscule to start with, has seen a steady decline from 1.5 per cent a few yearsback to the current 1.2 per cent. This is indeed inadequate for a country with the second highest population and the highest disease burden in the world. However, the recently released rules bring some much needed clarity. Adherence to regulations and ethical processes will build confidence amongst stakeholders, including patients

On March 19, the Ministry of Health and Family Welfare (MoH&FW) announced the new set of rules for drugs and clinical trials. These rules bring some clarity on many aspects and could change the entire scenario of clinical trials and research in India. For instance, according to new regulations, the time for approving applications has been reduced to 30 days for drugs manufactured in India and 90 days for those developed outside the country. The same was mentioned by Drug Controller General of India (DCG(I)) S Eswara Reddy at the 12th Annual ISCR Conference, Delhi held in February.

He had also said that "in case of an application for conducting clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India, the application is to be disposed of within 30 days. And, in case there was no communication from DCG(I), the application will be deemed to have been approved."

The rules will be applied to clinical trials, bio-availability or bio-equivalence studies, new drugs and regulation of ethics committees relating to clinical trials and biomedical health research. According to the Indian Society for Clinical Research (ISCR), the number of clinical trials being conducted in India, as a percentage of global trials, currently stands at 1.2 per cent, which was 1.5 per cent a couple of years ago. It is indeed inadequate for a country which has the second highest population and one of the highest disease burdens in the world.

The case of ‘Ankit Sharma’

For about past one year, 59-year-old Ankit Sharma (name changed to protect the identity of the patient as per clinical trial guidelines) from Haryana has been undergoing a clinical trial in Delhi for high cholesterol. A type-2 diabetes patient, he had suffered heart attack in 2002 and had undergone a Coronary Artery Bypass Grafting (CABG).

Over the next 16 years, he made the rounds of 10 different hospitals and underwent 13 angiographies. The patient’s next stop was All India Institute of Medical Sciences (AIIMS), where he underwent an electrocardiography (ECG) and then echocardiography (ECHO) came into the line. When quizzed by a doctor at AIIMS on number of angiographies, he said, "Doctors kehte rahe, main karwata raha. (Doctors told me to do them, I kept doing them)."

Distressed with continuous tests, he finally landed up at Medanta – The Medcity, where Dr Sanjay Mittal, Senior Director – Clinical Cardiology and Head of Research, Medanta – The Medicity advised him to join a clinical trial.

A stranger to this medical term, Sharma was a bit hesitant to pursue it. Nevertheless, once he was given a brief about the whole process, he filled the ‘Informed Consent Form’ and joined the trial last year. After the required lab tests were done, he was put on a course of medication, which ultimately helped improve his condition. He remains part of the ongoing trial, and most of his reports are fine with a team of doctors monitoring his health. The trial is currently in phase three and the final result is expected to be out in about five years, inform his doctors.

Clinical trials: The key for drug development

Clinical trials is key for any drug development. It has been going on since decades and the pattern of diseases has been changing, informs Chirag Trivedi, President, ISCR. He quoted a speaker from the ISCR Conference panel discussion who had said that the burden of non-communicable diseases is such that some years down the line, the impact on the GDP of the nation, if you build roads or if you don’t build roads, will be lesser, as compared to the entire negative impact on the GDP of the nation if you do not control diabetes and hypertension. "Thus, there is a need to come up with newer medication, as we are not yet able to find the cure for these diseases, we are just able to control them," Dr Trivedi had said.

Today, understanding of diseases is expanding which helps pharma companies to find out new molecules that patients need — that’s where the essence of clinical trials lies.

Shedding light on the rules and regulations, Dr Trivedi informs, "Some years ago, due to certain new rules introduced then which were against the basic tenets of clinical trials, there was a significant drop in the number of global clinical trials conducted in India. Worldwide, clinical trials kept on taking place, but we were not a part of those trials, and hence those drugs would not be introduced in India because the law says that trial data is required to get a drug registered, so that it can be then available to treat patients."

What numbers speak

"We are 16 per cent of the world’s population and have got 20 per cent of the global disease burden in India. It is such a large burden that we need to tackle it differently. As per the data available from www.clinicaltrials.gov, the US currently has close to 40 per cent of the clinical studies, the European Union has close to 30 per cent, while China has almost ten times the number of studies that India has today," informs Dr Trivedi.

In addition, he says that companies are supposed to register their studies into the public registry before they even enroll their first patient. It is a mandate since last 10 years.

Globally, it would cost $1.2 billion to $1.5 billion to get one drug from research to market, with the cost of many failures already built into this figure. The general probability of success is that in phase one, there is just 10 per cent chance that the molecule will see the light of the day. At phase two, the odds improve to 20 per cent and at phase three, it’s 60 per cent.

Dr Trivedi also informs that in 2010, we had 500 clinical trials in India, which dropped to 17 global clinical trials in 2013. Later, in 2014, these were approximately 70, which then increased to 97 in 2017, and similar numbers were witnessed in 2018 too.

The significant dip in the number of global clinical trials in 2013 caused some clinical research organisations (CROs) to shut shop post 2013. A further set back was the withdrawal of trials being run by leading academic centres like the US National Institute of Health (NIH) due to the stringent rules.

After several consultations between Central Drugs Control and Standards Organization (CDSCO) and industry representatives, the rules were amended in 2014 to make the process for clinical trials more balanced. Today, India is the only country where we have audio-visual recording of informed consents. The country also has a formula to determine compensation to be awarded for any trial-related injury, Dr Trivedi highlights.

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