‘’There needs to be an intense effort to educate the members of registered ethics committees for clinical trials’’

India has become a hub for clinical trials due to availability of state-of the-art infrastructure, skilled medical professionals in the field of medical research and lack of stringent regulation. However, the subject continues to be mired in controversy and has been getting a lot of negative coverage in the media lately. The approach taken up by multinational pharma companies and hospitals to conduct clinical trials has been questioned on various occasions. Dr Sita Naik, Advisor to Chairman, Research Task Force, Apollo Hospitals, tries to clear the air around the issue and explains the role of ethics committees within India in regulating the conduct of clinical trials in the country, in conversation with Raelene Kambli

The healthcare industry is being accused of conducting unethical clinical trails for multinational pharmaceuetical companies. What is your opinion on the same? How should the industry tactfully handle this situation?

Dr Sita Naik

This perception has gained ground because of some unfortunate, but infrequent episodes. The regulatory authorities are aware that the overall conduct of trials is fair and ethical but they get constrained by public perceptions and the resultant political reactions. They would like to create a more transparent climate that can allay these negative public perceptions. The industry should work with the regulatory authorities and the clinical researchers to ensure that all activities are done in the best interest of the participants and for the ultimate benefit of the patients.

Although Ethics Committees (ECs) have been around for some time, why is there a lack of understanding about the issues? What has gone wrong?

In the earlier days, trials were limited to larger academic centres which had adequate, senior persons with knowledge and integrity to run these committees. However, the rapid expansion of clinical research in the last decade, has led to a large number of new committees. This has led to less trained and experienced membership.

Also, there has been no emphasis on training about ethical issues for the medical professionals who make up the bulk of the membership. It is important to realise that questionable decisions may not always be due to suspicious intent but is also due to lack of informed decision making.

Is there a need for regulatory reforms and more stringent ethical safeguards? What are the key changes required on the regulatory and industry front?

The need for reforms have been recognised and these have been discussed and processes to bring these into action are ongoing. Apollo Hospitals Educational & Research Foundation (AHERF), in partnership with the Indian Council of Medical Research, Sanofi India and Quintiles organised a day and a half meeting which had excellent participation from all the stakeholders – researchers, members of independent ethics committees (IECs), industry etc. The objective was to discuss the various issues that are currently hampering the free growth of the field. The following major recommendations of this group have been submitted to the Committee set up by the Ministry of Health & Family Welfare (MoHFW) to consider the changes that need to be introduced in the regulatory process. We have been assured by the Chairman of the Committee, Professor Ranjit Roychaudhury, that the recommendations have been reviewed seriously by them.

• Training to EC members on key principles of good clinical practice, foundations of clinical research ethics and ethical philosophy, ethics review methodology and check-lists, compensation review and calculations, special ethical issues in developing countries, and national/international regulations.
• Allowing use of technology as a recognised tool in clinical trials and EC process (e.g: use of multimedia in Informed Consent Process; EC review meetings via video-cons, teleconferences forserious adverse event (SAE) review, compensation discussions, etc.)
• Longer time-lines for submission of report about adverse event (AE)/SAE by Ethics Committee (the current 21 days is too short to make correct assessments) to avoid the practical difficulties
• Establishment of an Indian agency for accreditation of ECs; followed by mandatory accreditation of ECs by this agency
• Dedicated full time staff to EC for administrative functions, documentation, filing and archival support
• Formation of more than one EC in institutions with more studies (with demarcation for studies for regulatory approval and for investigator initiated studies)
• Establishment of Regional/State ECs for smaller centres /non- institutional based studies
• The structure for EC can be such that in addition to a smaller core apex EC (6 to 10 members as it presently exists), a larger Ethics Organisation (up to 25-30 persons) that would include more junior energetic/enthusiastic associate members with less demand on their free time (such as junior doctors, internal Site Management Organisation (SMO) nominees, research associates and select nursing staff). While the Committee at the apex would be responsible for all approvals and key reviews, the associate members would help with administrative and analytical work, including review of SAEs for presentation to the EC, compensation related administrative activities, organisation of training activities, documentation of minutes of meetings, drafting of correspondence, drafting and periodic review of Standard Operating Procedures(SOPs), preparations for accreditation, etc. Ethical reviews of non-regulatory studies (e.g., for approved/marketed drugs and non-interventional research) can be handled by a sub-committee made up of associate members.

How can we improve the current situation? How can we strengthen ethical conduct of clinical research in India?

There should be early implementation of the suggested changes to the current regulations. In the meanwhile, while the accreditation processes are being put in place, there needs to be an intense effort to educate the members of registered ECs. All the institutions conducting trials should ensure that only appropriately qualified persons are selected as members and also facilitate training for the members.

What should be the role of the ethics committee?

The EC has the sole responsibility of ensuring the protection of the participants – patients and healthy subjects – of clinical trials.

What should be the role of the hospitals and research institutes that conduct clinical research and trials?

They have the responsibility to conduct the trials being undertaken in their institutions in the best principles of good clinical practice and always ensure the rights and safety of trial participants.

What is your message to the industry on this matter?

It is unfortunate that due to a small group of defaulters, the whole activity has been put into disrepute. For the benefit of Indian patients it is important that clinical trial activity should continue and the required climate should be generated at the earliest with the active collaboration of the industry, the Site Recruitment Organisations (SROs and Contract Research Organisations (CROs), the institutions and researchers.

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