In 4 yrs, 88 clinical trial volunteers died due to side effects
CLINICAL TRIALS ARE DONE TO TEST SAFETY AND EFFECTS OF NEW DRUGS AND WAYS OF ADMINISTRATION
MUMBAI: At least 1,100 people who took part in clinical trials over the past four years have died, and 88 of these deaths were caused by direct side effects of the trials, the health ministry told the Rajya Sabha last week.
But, with little transparency on how such deaths are investigated, and new rules relaxing how clinical trials are conducted in India, this data could be a poor estimate, said experts.
Clinical trials are done to test safety and effects of new drugs, dosages and ways of administration to help improve public health. According to government data, there has been a steady rise in the number of people registering for trials in the Clinical Trials Registry of India (CTRI) — an online public record system. The health ministry said there were 859 registered volunteers in 2015, 873 in 2016, 2,516 in 2017 and 3,869 in 2018 (till November). While there are more volunteers, those being compensated for their participation has reduced, suggests independent information from the Central Drugs Standard Control Organisation ( CDSCO). CDSCO reported 381 deaths of volunteers in 2015, 378 in 2016, 345 in 2017 and 339 in 2018.
And, of these deaths, 18 were directly linked to trials in 2015, 27 in 2016, 30 in 2017 and 13 in 2018, CDSCO’S ethics committee said.
When it came to compensation, only in 2015 did families of all 18 participants receive compensation. The following year, 25 of 27 were compensated; it fell to 18 of 30 deaths in 2017, and to one of the 13 deaths in 2018.
Experts said ambiguity over how the compensation mechanism works could be one reason.
“It is sad that such important data is not available in the public domain but has to be accessed through a parliamentary process,” said Malini Aisola, the convener of the All India Drugs Action Network (AIDAN), an Ngo.“according to law, patients or families of patients taking part in clinical trials must get a minimum compensation of ₹8 lakh. But i n t he case of t he only reported death of 2018, the family was given just ₹4.87 lakh, according to the ministry’s own data,” Aisola said. Experts said new, relaxed rules, which came into effect in February 2018, have paved the way not only for poorer regulation of how clinical trials are conducted, but also gave room for more corruption in the process.
“The New Drugs and Clinical Trials Rules don’t have any specific guidelines on how volunteers are selected,” said Shelley Saha, a member of the Swasthya Adhikar Manch, an NGO that had filed a public interest litigation in the Supreme Court in 2012 over the lack of transparency in medical trials and compensation.
“The only requirements seem to be that volunteers are ‘healthy’ or are ‘patients with a target disease’. There are no guidelines about selecting them, which means there are several cases of volunteers being lured from poorer, rural areas with the promise of free drugs, therapies and even jobs,” Saha said. Saha pointed out that how the Clinical Trials Registry of India’s website — where trial processes, status and results of clinical trials should be updated, has no realtime information. Most of the available data doesn’t reveal basic details such as sample size of the study, whether or not studies were successful, or even if the drugs have been made available to the public or stopped after the study was done,” Saha said. Under the new rules, clauses such as restricting one investigator to three trials, compulsory audio-visual reporting and only allowing hospitals with at least 50 beds to conduct trials have been lifted. “While this has increased the number of trials, it has also seriously hampered quality control measures.”