An expert panel set up by India’s health ministry has recently recommended that Indian drug regulatory authority should give permission for only those clinical trials conducted at centers accredited for that purpose. All clinical studies seeking approval should be carried out under the guidance of a principal investigator who is accredited. Not only the centers and the chief investigators, but the ethics committee of the institute must also have accreditation, if they want the regulator’s nod.

It goes without saying that accredited trial centers will have more consistency and more acceptability. The process itself shall go a long way to raising the bar of CROs by helping build SOPs into the emerging clinical research industry in India. Independent trials conducted in accredited centers and run under the supervision of accredited clinical investigators would be something unprecedented and if enforced, could clear the air surrounding the clinical research landscape, which is currently under intense media scrutiny for alleged negligence and lack of transparency. 

For granting accreditation for trial centers, clinical investigators and institutional ethics committees the expert panel has mooted to constitute an authority in the name of Central Accreditation Council.

But critics are skeptical about how soon India’s drug regulator would be able to effectively implement the proposals. Clinical research is a very competitive space. A well-trained investigator can make a difference by adhering to processes. Since there are very few accreditation facilities, where will the authorities find professionals required to man the training centers?

A Formula For Compensation
The expert committee, in another proposal with far-reaching implications for the industry, has suggested that the trial sponsor/investigator to be held accountable for providing treatment for trial subjects in case of adverse events/serious adverse events (AE/SAE) until the resolution of the case. The care cover should be extended to all participants in the study irrespective of whether they belong to control group or placebo arm.

To ensure the safety of the participants in clinical research, the regulator has already listed a slew of measures in the recent months. The latest being the one about monetary compensation for clinical trial victims — a highly debated issue in India. Human rights groups and NGOs have been joining ranks in mounting attack against the authorities, arguing that CROs operating in the country are not following the norms while compensating subjects in case of trial-related injuries or deaths.

Addressing this long-standing dispute, a panel of experts came out with a new ‘formula.’ The mathematical formula bases two factors — age and health risks — while calculating the compensation money for the trial victim. In case of deaths during trials, the compensation amount can vary from a minimum of Rs. 4 lakh  ($6400) to a maximum of up to Rs. 74 lakh  ($118,441), depending on the age and the risk factors of the deceased. Higher compensation will be given to subjects belonging to the productive age group, as defined by Workmen Compensation Act.

In order to assess the risk factors, participants are categorized into five categories: ‘terminally ill with expected survival of not more than six months,’ patients with ‘high risks with expected survival of six to 24 months,’ patient with ‘moderate risks,’ patients with ‘mild risks’ and ‘healthy’ volunteers.

However, companies running the trial should give a fixed amount of Rs. 2 lakh ($3200) in case of patients whose expected mortality is 90% or more within 30 days.

Sponsor Pay Disclosure
According to the Drugs Controller General of India (DCGI), this formula, based on a scientific methodology, would ensure complete transparency in the way compensation is calculated for clinical trial victims. Meanwhile, clinical research firms see the whole formula defying logic and contend it is “is based on the Minimum Wages Act.”

Also, it has been made mandatory for the investigators maintain an audio-video clip of the informed consent process of individual subjects for the record. The recorded data should include the procedure of providing information to the subject and his understanding on such content, according to a recent draft notification by the health ministry.

The ministry expects that the electronic record keeping would allay concerns that the informed consent process is not usually followed by all CROs. But several CROs feel the videography aspect needs more clarity, as filming of the informed consent process could infringe upon the universally acknowledged confidentiality clause of doctor-patient relationship.

The most contentious issue seems to be a recent order from the DCGI asking clinical research firms to disclose all the details pertaining to the payouts made by the sponsor to investigators while making submission-seeking permission. They wonder whether it would be practical to list all the financial support, fees, honoraria, payments in kind, etc. to be paid to the investigator or his representative even before the start of the study.