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Govt sleeping over clinical trial report

Shyama Rajagopal
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Report says Health Research Centre patients were recruited from medical camps conducted in rural interiors

The government is yet to take any action on a report on clinical trials in the State submitted more than six months ago.

Indicting one of the centres in Thiruvananthapuram that was set up to conduct only clinical trials, the panel had found that the institution had grossly violated the guidelines of Indian Council of Medical Research.

V.N. Rajasekharan Pillai, ex-officio Principal Secretary for Science and Technology Department and chairman of the six-member committee that studied the allegations of clinical trials, told The Hindu that some of the patients who were under trial seemed happy as they were even paid for being part of it. The patients also felt that they were getting more medical attention.

The committee had found that there was no in-patient facility to treat patients in case there was any adverse event during with the trial.

However, Prof. Pillai said the committee had only investigated the clinical trial allegations against the Health Research Centre (HRC), Thiruvananthapuram. No other centre in the State had cooperated with the committee for the study, alleged Prof. Pillai. Though many centres are learnt to have ended their clinical trials because of the ambiguity it provided, there could be institutions that did continue the trials, he added.

The panel was set up in August 2012 following widespread allegations. However, till date the government has not taken any action nor asked the panel for a detailed report on the subject.

The panel’s report said that HRC was registered as a company to conduct human research and not as a hospital. They had an ethics committee with their investigators as members and who also voted for continuation of the study. This grossly undermined the ICMR guidelines, the panel had found.

Even the death of two patients never was discussed in the ethics committee as per the minutes. It was only mentioned by an internal committee of the institution.

Prof. Pillai’s panel while verifying records and collecting personal statements of patients got strong evidence to prove that patients were recruited from medical camps conducted in rural interiors.

Vulnerability increases if the patients are illiterate or belong to the lower income groups, and often patients attending medical camps fall under these categories, observes the report. The panel had taken HRC as a case study and had observed that any institution set up for clinical trials could have a similar profile.

The panel comprises C. C. Kartha, professor, Rajiv Gandhi Centre for Biotechnology, V. Ramankutty, professor, Achutha Menon Centre for Health Science, Sree Chithira Thirunal Institute of Medical Sciences and Technology, Dr. Anoop Kumar Thekkuveettil, member secretary, Institutional Ethics Committee, SCTIMST; C.S. Satheesh Kumar, Drugs Controller and V. Geetha, Director, Medical Education.

They committee had also given a few recommendations to the government on making clinical trials more transparent. One was to bring in a piece of legislation to prevent clinical institutions from being set up with the sole aim of conducting clinical trials. Two, all centres conducting clinical trials should have in-patient facility. Three, begin clinical registry, similar to the Central registry, with complete details of the study title, hospital and clinicians involved, adverse events reported etc so that all trials can be tracked. Four, compensation to patients who suffer adverse effect of study drug. Five, a two-pronged awareness initiative to educate the public about the importance of clinical trials and to educate the patients about their rights.

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