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Clinical trial regulations to be developed through consultative approach

Our Bureau, Mumbai
Thursday, December 18, 2014, 08:00 Hrs  [IST]

With clinical trials research having faced a slowdown since 2012 after repeated directives from the apex court on safety procedures followed in the trials, clinical research experts, however, say there is lack of clarity on the norms on which eligibility for compensation is decided among other issues.

Issues like irrational and unbalanced compensation guidelines, unpredictable review and approval process and operational orders such as mandatory across the board audio visual recording of informed consent, limiting the number of trials an investigator can conduct at a given point in time and limiting the distribution of clinical trial sites were deliberated during a seminar on “Clinical research in India: Where do we go from here?” organised by Indian Society for Clinical Research (ISCR).

Said Suneela Thatte, president, ISCR, "Regulations and guidelines need to be developed through a multi stakeholder consultative approach that are based on science and highlight a commitment to patient safety, ethics and confidentiality in line with globally accepted practices. There are situations unique to India like literacy, socio economic considerations and social cultural norms which must also be taken into cognizance in the development of guidelines so that no one is denied the right to participate in research because of these challenges as with audio visual recording of informed consent for instance”.

She further added that there is need for more trained resources within CDSCO to ensure the smooth roll out and governance of clinical research in the country. Guidelines will remain guidelines with good intent unless there is operational guidance and trained staff to ensure their implementation.

To address the concerns that have been raised about the conduct of clinical research in India, there is a need to have an objective system to accredit investigators, sites and ethics committees. The accreditation should be provided by an independent third party and reviewed at periodic intervals.

"If we want to grow clinical research in the country and ensure a healthy balance of research across geographies, the Government needs to invest in better infrastructure particularly at government run hospitals and institutions. It is unfortunate that many patients do not have the option of participating in clinical research in many areas of our country because sites are ill equipped and investigators not trained in clinical research," Thatte added.

Experts pinpointed that misreporting and sensationalism of clinical research in India has created fear and suspicion amongst the public at large. A key requirement is public education and awareness not just about clinical research in general but also about the rights and responsibilities of those who participate in a clinical trial. There is a need to create an environment where patients have the confidence and trust that their participation in a trial is to their benefit.

"We are in a situation where there is a crisis of confidence. Greater transparency and openness by the regulators will go a long way in restoring trust amongst various stakeholders. Although there have been attempts by regulators to review several of the challenging regulations through a multi-stakeholder collaborative approach and a commitment that change will come sooner than later, the key issues that stakeholders across the clinical research spectrum continue to face need to be resolved on a war footing, concluded Thatte.


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