Balancing research with patient protection

It’s never an easy task to regulate clinical trials, as a fine line needs to traced between encouraging genuine research and protecting the patient at the heart of this research.

That’s the challenge the recently issued New Drugs and Clinical Trial Rules (2019) has also had to grapple with. And its implementation will reveal whether authorities have indeed managed to strike this delicate balance.

Clinical trials involve testing a medicine on a human volunteer, and past incidents of malpractices and ineffective norms had cast a huge shadow on the segment.

But the recently issued 100-odd page Rules have shored up some confidence and found support among industry-hands and policy experts. A huge step has been taken to iron out laborious processes and contentious issues, they say. But the Rules are not without their concerns on distinctions being made between commercial drug trials and non-commercial academic research. Or the absence of a strident patient voice in the entire process that is, in fact, of and for the patient, say seasoned regulatory-hands.

Clear and standardised

Chirag Trivedi, President with the Indian Society for Clinical Research, says the Rules are balanced for patients and researchers. There is greater clarity and standardisation in approval time-lines; pre- and post-application discussions with regulators on requirements to get approval for a drug trial; bio-availability and bio-equivalence studies have been included under the law and trial waivers have been included for new drugs with a safety track record. Over five years ago, the Supreme Court had directed the Government to bring in stringent regulations to ensure a patient is protected in clinical trials. Critical requirements — like getting the informed consent of a patient participating in a trial, taking audio-video recordings of consent being given, except in vulnerable cases, patient compensation and the medical management of their injuries while on trial — were brought up front and centre.

Over the years, the Government has been making changes in standardising processes, instituting reviews by Ethics Committees, etc. And the system has been working well, says Trivedi. The contentious medical management of patients participating in a trial, he says, has been clarified, with the new rules indicating that it was required till the investigator decided whether a patient’s injury was caused by the trial or not. Trivedi disagrees that the patient’s voice did not find representation in the present scenario and adds that they could raise issues with the EC and escalate it further.

Independent lawyer Veena Johari points out the conflict in having an investigator assess if the patient injury was linked to a trial, especially if the investigator was paid by the sponsor of the trial (a company). The patient should be an equal participant in a drug trial, she says, Instead, the patient is the least acknowledged and at maximum risk.

Lack of transparency

Clinical trials get cloaked in distrust because of the lack of transparency over whether a patient injury or death was linked to the drug trial. And the compensation to be paid, as a result. In the interest of greater trust and patient participation, experts suggest that industry step up and pay a patient in case of injury, and not haggle over whether it was linked to the trial.

Johari also questions the differentiation between drug trials for commercial purposes and biomedical research and questions. Will clinical trials need to now only adhere to Good Clinical Practices norms and not the ICMR (Indian Council of Medical Research) guidelines on protection of patients in bio-medical research, she asks. ICMR’s guidelines were comprehensive and incorporated suggestions from public hearings and stakeholder meetings, she says. Keeping academic research under a different regulatory requirement may also open up a back-door entry for companies to undertake research, agrees another regulatory expert.

The Government has missed the opportunity to bring all research under a separate, comprehensive law, says Johari, pointing to the new Rules that are under the Drugs and Cosmetics Act.

Architect of the ICMR guidelines on patients used in research, Dr Vasantha Muthuswamy is happy the guidelines have been brought under the law, even if not as a separate law in itself. “We have been waiting from 2007,” she says, as several drafts went back and forth, leaving many to wonder if they would see it in their lifetime!

With concerns still being raised on loopholes in the new Rules, the Drug Controller’s office would need to address them, lest it tips the balance they are trying to achieve.

COMMENT NOW