Clinical Research Organizations (CROs) and global sponsors have urged Drugs Controller General of India (DCGI) to come out with a set of stringent regulations for the clinical trials sector for better clinical research outcomes.

The regulations should include registration of all CROs, Site Management Organizations and Ethics Committees (EC) engaged in clinical trials with the DCGI. All Institutional Ethics Committee/ Institutional Review Boards should seek an approval of the EC member representatives as per the Indian Council of Medical Research (ICMR) suggestion before it is formed. The IEC/IRB should be empowered to enforce strict compliance of all guidelines and they should closely monitor trials. The last word on a foolproof Informed Consent process is to usher in video-taped patient consent.

Currently, CROs and clinical research practitioners adhere to Schedule Y of the Drugs & Cosmetics Act which includes ICH and GCP norms. There are also guidelines issued by ICMR which are not yet mandatory.

The registration of the IEC/IRB's will allow the regulatory authority to have a first hand information of all drug studies being conducted, if it is made mandatory to submit timely reports about activities at such sites. While the ICMR sought details of all IECs, only 20 per cent have registered so far.

There are 200 hospitals, over 400 principal investigators engaged in clinical trials. Currently, India is conducting 644 trials. Most large hospitals have well structured ECs that are transparent about information on the professional status and the tenure of service of the representatives. But in the case of one-man private hospitals, the chairman of the facility becomes the head of the EC. In such cases, known professionals of the hospital chief become EC members, which provide room for formal practices.

According to ICMR, while ECs should not only ensure safety and rights of the patients at the beginning of the trial, but should also closely monitor the study regularly till its completion. The absence of stringent norms and lack of inspectorate could lead to malpractices. The clinical trial sector needs a foolproof mechanism. There is a need to have regular audits of the trial sites so that the west will repose more faith and be convinced on the Indian clinical trial expertise and data generated from here. Therefore, regulations are indispensable for the sector, Dr Ramananda Nadig, president and deputy dean, Clinical Research Education and Management Academy (CREMA) told Pharmabiz.

Since the DCGI is bogged down by shortfall of personnel and trained expertise to oversee the clinical trial sector, an external body or a third party organization, approved by DCGI to conduct an audit is a far simpler option to keep track of non-complying CROs. If the DCGI pins down one non-complying site, penalize the violators and black list the Investigator/SMO/ CRO, it would make a huge difference to the quality of trials at the sites, stated Dr Nadig.

In order to ensure total reliability in the patient consent, MNCs & CRO's have suggested that complete video-taping of interaction between the principal investigator and subject during clinical trials. The strong bondage between the doctor and patient in India is viewed by global CROs and pharma MNCs with much suspicion. If the entire process of Informed Consent can be seen and heard via video recording then there would be no scope for the patient to be forced, cajoled or bribed and recruited.

In an era of digital record capture, good informed consent practices during human studies will strengthen the Indian clinical trial process, added Dr Nadig.