Blacklist people or organisations flouting the rules that govern clinical research, say industry representatives, in an effort to bridge the distrust between them and the rest, when it comes to clinical trials.
The industry has, among other things, asked Government to have a black-list of people, where it is proven beyond doubt that they have indulged in wrong doing, said Suneela Thatte, head of the Indian Society for Clinical Research (ISCR), a professional body representing clinical research organisations.
The Food and Drug Administration (the United States regulatory authority) has such a checklist, she added. Thatte’s appointment to the top-job at the ISCR earlier this month, comes at a time when clinical trials are under a huge shadow of mistrust, following reports of deaths and adverse reactions.
Clinical trials involve human volunteers and patients who participate in studies exposing them to a new medicine or relatively known drug, in the interest of testing the safety and efficacy of the drug.
But when trials go awry, and there are adverse events or deaths, it becomes difficult to establish whether the incidents are directly linked to the trials. And this leads to mistrust, as questions emerge on whether norms were followed or flouted. At present, the clinical trial segment is seeing a tightening of procedures by the Government, under the watch of the Supreme Court.
According to media reports quoting a Health Ministry submission in Court, of the 2,644 deaths during trials in a seven-year period (2005 to 2012), 80 deaths were found linked to the clinical trial. The idea of having a violators-list of researchers or organisations who flout the law found acceptance among public-health workers too. A representative who works closely with Government on the evolving clinical trial norms said, if wrong practices are found, the researchers, ethical committees or site should not be allowed to do a trial in future. This list of violators should be accessible to the public as well, he added.
Patient protection
Responding to industry representatives’ apprehensions that clinical trial numbers were falling in the country due to uncertainties governing the segment, Drug Controller General of India G.N. Singh said, the Government’s aim was to protect the safety and rights of the patient and guidelines were being evolved to protect any subject participating in a trial.
Trials approved in the country have seen a dip from 500-odd in 2010 and 262 in 2012, to just six applications in January.
Accreditation and audits
Thatte calls for robust governance, including the registration of ethical committees (that watch-over individual clinical trials), besides the clinical trial sites themselves.
The drug regulator should be strengthened to undertake registration and accreditation of doctors and researchers and clinical trials should be put through regular independent audits, added the health-worker.
Even as the basic definition of new drug trials and compensation are being refined in the existing law, care should be taken to put the registration processes also under scrutiny to keep out unscrupulous people who operate in the guise of being independent professionals, he cautioned.