#Clinicaltrials : Are India’s Ethics Committees weak links in the chain?

7 Jun

Clinical trials, that hot-button subject hogging headlines up until a year ago, appears to have quietly slipped into the realm of business-as-usual. However, there are still some knotty issues to be resolved. Chief among them is the oversight of Ethics Committees (ECs) as was evident at a recent event I attended.

ECs – which are a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it.

In 2013, for the first time, the Indian government ordered that all ECs be registered with it. A year later, it also called for their compulsory accreditation with an independent body. Until then, hundreds of clinical trials had been conducted under the supervision of ECs even as there was no real surveillance of the ECs themselves.

Inadequate oversight

Since then, while a raft of them have registered with CDSCO, the office of the central drugs regulator (and are now seeking renewals), few have been inspected by it, let alone accredited. I spoke to K Bangarurajan, Deputy Drugs Controller General of India (West Zone) at a recent event on clinical trials in Mumbai that was co-hosted by the Indian Society for Clinical Research and K.E.M Hospital to mark International Clinical Trials Day. He confessed to an inability to take up inspections on the scale that he would’ve liked because of a manpower crunch. “The regulator also has to see to other areas like WHO GMP (manufacturing), blood bank inspections, compliance..” he told me. Maharashtra has a substantial number of ECs but hardly any had been inspected, he said. “We have requested for more staff.”

In parallel, EC accreditation has yet to start. In 2014, the government had mandated National Accreditation Board for Hospitals and Healthcare Providers (NABH) under the Quality Council of India (QCI) to draft standards.  It had said that accreditation would be made mandatory. But participants in the event wondered about the status of this effort and whether it would see the light of day. “Is QCI’s involvement in limbo?” was one of the questions raised.

For clarity, I later contacted Bhupendra Kumar Rana, joint director, NABH in New Delhi. NABH had already submitted the final standards for accreditation to the Union Ministry of Health and Family Welfare a couple of months ago, he said. It had hired staff and trained outside experts and was ready and equipped to start the accreditation programme if the Ministry wanted it to, he added.

So the right question to ask is probably this : what’s holding up the Ministry’s green signal to NABH?

No compulsion

Even if accreditation does begin, it appears that it will be voluntary just like for hospitals, in spite of what the government had initially said. And if the experience of hospitals is anything to go by, it is going to be a slow process. India has around 1000 registered ECs a majority of which are inside institutions. The rest are independent.

Some experts say that accreditation should stay voluntary. “In general, accreditation the world over is believed to be a voluntary process,” said Urmila Thatte, head of the Department of Clinical Pharmacology at K.E.M. Hospital, at the same event. “It will be a humongous task for India (if made mandatory),” she said. Thatte advocated more aggressive inspections. “Even if you inspect 10 per cent of the ECs and put up the warning letters issued to them, others will be more careful,” she said.

The issues raised should not be dismissed. Not all ECs are made equal. While there are some who have set high standards for ethical review, there are also those that are known to be swayed by the heft of investigators who approach them for clinical research approvals. In some cases, ECs defer to a few influential or knowledgeable members among them, begging the question : are such decisions truly representative of the group? Not all have the necessary training to make judicious decisions in complex cases.

In parallel, they are being given more responsibilities, not less.

Purely academic

Earlier this year, the government freed academic clinical research from seeking its permission, choosing instead to vest this power with ECs.  This means that clinical research that is purely academic in nature and has no commercial purpose does not need the regulator’s permission as long as the EC of the institution has approved it. The regulator, however, has to be kept informed of such research. By doing this, the government freed research that mostly involves comparing known drugs and therapies.

But some such as C S Pramesh, co-ordinator of the National Cancer Grid and key investigator in many oncology trials, object to this. “While 90 per cent of trials are to judge comparative effectiveness, there are some high-risk trials such as those for gene therapy,” he said. “These should be subject to the same treatment as ‘commercial’ trials,” he said.  Thatte too asked if, in the absence of adequate training, institutional ECs were equipped to handle this additional responsibility. “The notification on academic research has opened Pandora’s Box,” she said.

For their part, at least some ECs are unhappy with the additional documentation that registration renewals have called for, such as a brief summary of every trial that an EC oversees. One EC member pointed out that the committee had 1400 trials under its supervision at any point of time and that this was proving to be an onerous task.

One has to ask : is the regulator making up for insufficient feet-on-the-ground with greater amounts of paperwork? If so, not the most encouraging sign. To be fair, the Indian government has made a strong push for reform of clinical research in the last few years with a raft of edicts aimed at improving subject safety and fair treatment.

But well begun is still only half done.

Pic sourced from Google Images

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2 Responses to “#Clinicaltrials : Are India’s Ethics Committees weak links in the chain?”

  1. Surinder kher June 7, 2016 at 5:44 pm #

    Dear Gauri,
    Undoubtedly the intent of the regulators was to get some accountability in place for the ECs and also allow the ECs to come upto some reasonable standards in terms of their operations etc. this certainly was a good initiative. However, this came in as a reaction to certain issues and as always no ground work or thinking was done both by way of looking at research requirement as a whole and also at how this will be handled and controlled going forward. The challenge with us a country is that we want to frame rules but not sure how to implement and manage these.

    Let me talk about the broader aspects of research requirements. Two types of registrations were granted. One that were institutional ethics committees that can approve any and all types of trials. This means any clinical trial including a BA/BE trial can be approved by these committees. The independent ECs that were existing were allowed only to approve BA/ BE studies. I have not till date understood the logic when I am registering and also ordering accreditation. Research does not only involve institutions only. Research also involves post marketing studies, clinical epideiomolgical studies, patient outcome studies etc and all these studies may not be done in hospitals alone. You need to go to clinics and health centers also in interiors. Which ECs do you go to? These type of studies have to be positioned some way. from DCGI point of view these are all clinical trials dealing with patients and for that you need 50 beds etc etc as a requirement. You cannot go to independent committees as they only approve BA/BE studies. In today’s world of research you need EC approval before you even want a publication in a journal. So are we facilitating or impeding research? This is is the lack of vision and thought that our non research oriented policy makers have. They just want to address the problem to run away from it and not think through.
    As a result of the above the IECs who have been mandated to give only BA/ BE approvals also give approvals to post market and epidemiology type approvals I mentioned above. The SOps most of them submitted as part of registration process describe that they can approve any and all types of studies( what they used to do anyway before DCGI restricted them), there is no inspection by DCGI team, no accreditation process has been initiated etc. so the whole purpose of saying that ECs should be registered has remained as an event only and forgotten. If there is a vision and a plan then things could be in place. When we talk about this with office of the regulator we only come back to hear that they do not have manpower. That was known to them even when they initiated this process.
    To be practical we have to live with this the way it is and we have learned to do that as Indians. We will have another ISCR or similar session, you and I will write blogs and comments and the show will go on.
    Is there no way we can correct and do this? Yes there are ways to do this? let government come forward and there are enough people in this country who can help, advise and help implement this but government does not want anybody outside their circle to get involved. They do call outsiders for their comments but do what suits them and not the country necessarily.

    Liked by 1 person

  2. Dr Omkar P Asthana June 10, 2016 at 1:52 pm #

    Concerns expressed re genuine and needs to be addressed by competent authority.Delay or lack of clarity in the policy will adversely affect the mileu and scope for undertaking Clinicaltrials in India ,As a consequence to this many sponsors from west have moved out of India and Thailand ,Bangladesh,China ,latin American countries have become the preferred sites by the sponsors which is agreat loss to the nation ,This situation needs to be reviewd and appropriate steps may be taken to restore confidence of Investigators,sponsors and trial centres .

    Like

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