ICMR to regain trust in clinical trials

The Indian Council of Medical Research (ICMR) should work along with the various player in the pharmaceutical industry of the country to regain the trust of the public in their clinical trials and authentic collection of patient data by actively engaging them more transparently, observed a group of parliamentarians who studied the activities of Department of Health Research (DHR) for the budgetary allocation to the health research section under the Union Budget 2022-23.

The Members of Parliament have observed the various challenges faced by the Indian Council of Medical Research (ICMR) in operationalizing clinical trials in India during the current Covid-19 pandemic in a recently submitted report of the Department-Related Parliamentary Standing Committee (DRSC) on health and family welfare. The parliamentarians are under the chairmanship of Prof Ram Gopal Yadav,

It has also appreciated the Indian Council of Medical Research (ICMR) for developing the Indian Clinical Trial and Education Network (INTENT), a pan-India clinical trial network that can be a single, ready platform for conducting any rapid good quality and randomized clinical trials.

“The Committee, however, believes that there is a general lack of public confidence in the healthcare/pharmaceutical industry, and the Committee apprehends that slackening public confidence might pose a hurdle in conducting clinical trials,” it observed. It recommended Indian Council of Medical Research (ICMR) work in cohesion with the country’s pharmaceutical industry to regain the trust of the general public by engaging more transparently.

“The ICMR should also make more efforts to educate and inform patients and society about the benefits of engaging in clinical research and allowing authentic collection of patient data,” it asserted.

Indian Council of Medical Research (ICMR) has informed this Committee that the challenges it faced in operationalizing such clinical trials in India during the current Covid-19 pandemic, such as the fact that the health care workers were already overloaded with tasks like Covid-19 tests and treatments and, as such, setting aside time for quality conduct of trials was complex.

The patients, once discharged, were also reluctant to revisit the hospital. Thus, any follow-up had to be done virtually. The collection of samples like convalescent plasma proved to be a challenge and required efforts to give motivation and counseling to potential donors. All training and monitoring of various study sites had to be done virtually because of restricted movement.

To facilitate result-oriented trials and to combat any such future challenges, the Indian Council of Medical Research (ICMR) has initiated a pan-India clinical trial network – Indian Clinical Trial and Education Network (INTENT), which will be a single, ready platform for conducting rapid but good quality and randomized clinical trials. Capacity building of researchers across the country and improving public awareness of people regarding medical research were some of the other objectives of this network.

The Committee has also recommended that the Indian Council of Medical Research (ICMR) should establish a BSL-IV lab each in everyone one of the four zones, and the DHR should launch more mobile laboratories because such mobile units are likely to be of great help during pandemic outbreaks, particularly in rural and remote areas.

It has also been recommended that the DHR-ICMR formulate regulations and national policy to oversee dual-use research. Dual-use research refers to experiments mainly conducted for peaceful purposes but that can be altered or modified to cause harm. DHR/ICMR should conduct proper training and develop strict and exhaustive guidelines for bio-safety and bio-security.

“Considering the pivotal role of Indian Council of Medical Research in biomedical and health research in India, the Committee is deeply concerned to note the large gap in funding of ICMR compared with health research institutions of countries like US, UK, France, and China. What worries the Committee more is that the allocation of funds to ICMR and subsequent utilization by ICMR has always been less than the projected demand, even in the Covid-years, where the need for adequate funds and optimal utilization was the call of the hour,” it opined.