ICMR to develop Phase 1 clinical trial sites at Govt Institutes
An expression of intent is sought from institutions with the necessary facilities and capacity available to participate as ICMR's Centres for phase I clinical trial, which will enrol appropriate participants to successfully execute these trials.
New Delhi: The apex research body, the Indian Council of Medical Research (ICMR) is planning to establish sites for phase I clinical trials at adequately equipped government medical colleges and institutes and has also issued a public notice calling for participation regarding the same on June 9.
Through public notice, ICMR has invited proposals from institutions that are willing to participate in the programme.
The notice states, "The Centres will function as standalone facilities capable of effectively executing phase I clinical trials of the highest quality. ICMR will provide technical, financial, and administrative support. ICMR plans to have MoUs with universities/ institutes/ private organizations to identify and evaluate investigational products/ lead molecules through these Centres for phase I clinical trial."
As per ICMR sources, the initiative is being taken after the cabinet secretary asked ICMR director-general Dr Balram Bhargava, who is also secretary of, the Department of Health Research to work on this as a priority.
In phase 1 clinical trials, a product is used on humans for the first time to ensure its safety after it is successfully tested on animals. The sources at ICMR stated that the Covid pandemic has highlighted the importance of speedy clinical trials and added that there are very few phases I clinical trial sites in the public sector at present.
For phase 1 trials, the sample size is usually small, and only healthy people are enrolled for phase 1 trials. However, there are chances of untoward occurrences or medical emergencies that need to be handled without delay since the molecule is being tested on humans for the first time. Hence the availability of appropriate infrastructure for the treatment or resuscitation of a trial subject is important for phase I clinical trial sites.
Calling for participants, the ICMR notice states, "An expression of intent is sought from institutions with the necessary facilities and capacity available to participate as ICMR's Centres for phase I clinical trial, which will enrol appropriate participants to successfully execute these trials. The selection process of Centres for phase I clinical trial will be at the discretion of ICMR, following due processes."
A senior scientist working at the ICMR told the Print, "There are hardly any phase I clinical trial units currently in the public sector. We have only just started working on this and have drawn up the essential criteria." The scientist added, "The cabinet secretary had asked Dr Balram Bhargava to work on this. Currently, all the phase I clinical trial units in the country are in the private sector. It's important to have these units at government institutes because the private sector will work on a molecule based on the probability of profit, not public health needs."
The ICMR had partnered with Bharat Biotech for the development and trials of Covaxin, during the Covid pandemic, which was developed from the SARS-CoV-2 virus isolated by the National Institute of Virology, Pune.
According to a senior ICMR scientist, the necessary facilities needed by the participating facilities include the wherewithal for cardiopulmonary management, expertise to tackle allergic reactions, expert handling of fluid management, and resuscitation facilities. Other criteria include a minimum space of 500 square feet for three beds, alarms in all areas likely to be occupied by the trial subjects, toilets, showers, a recreational area, up-to-date equipment calibration certificates, an emergency trolley, and facilities for continuous monitoring such as ECG, pulse oximetry and measuring vital signs such as blood pressure, heart rate and temperature.
Along with the availability of physical infrastructure, the institutes also are required to meet the criteria for trained manpower. They are required to have standard operating procedures for round-the-clock handling of common medical emergencies like syncope (temporary loss of consciousness), hypotension, anaphylaxis, cardiac arrest, and immediate maintenance of life support, as well as the transfer of participants to intensive care when required.
The participants are required to make the final submission by 8th July 2022. The public notice issued by the ICMR can be accessed through the following link;
https://main.icmr.nic.in/sites/default/files/upload_documents/ICMR_CAR_PhaseI_EoI_Ver_01.pdf
