Clinical trials in India — a delicate line to tread

What started as a rare reporting subject only a few years ago has become a frequent fixture for newspapers and magazines — ethics in clinical trials in India.

Unfortunately for the industry, most of the coverage focuses on the ill-effects of doing investigational clinical trials on the Indian population. Examples abound of clinical trials by global companies in remote locations on gullible patients, leading to deaths or long-term serious adverse events.

Though dramatised out of proportions by television channels, much of the information in public domain is correct. As a consequence, although the clinical trials industry has bright prospects, the edge is gradually getting blunted.

Who is to blame?
Sponsors and clinical research organisations (CROs) are smart business associates. It would be hard to corner them for violations as they do follow the norms and submit to the regulatory agencies piles of documentation involving elaborate consent forms signed and accepted by trial subjects.
Investigators — the bridges between CROs and patients — are the holy grails, claiming to follow rules to the tee.

Regulatory agencies cannot be faulted as enquiries or investigations — mainly constituting government representatives — may not yield much to nail them. With a sharp rise in the number of trials in India, overburdened ethic committees that draw independent representatives from various fields are seen more as nominal signing authorities. And many critics question their independence in allowing trials on drugs that may be perceived risky to patient safety.

In all the divergent clashes of stake holders, the big loser is the patient.

Most cases of violation of good clinical practices that have stood out sourly are from India’s small towns or rural areas. Some NGOs claim patients, in their fight for survival on affordable treatments, have often signed on consent forms without going through the details involved on being tested on an experimental drug. More alarming is the fact that in many cases, the countersigns found are of doctors and not independent witnesses. With all the faith that a patient poses in his doctor for medical treatment, that act reflects poorly on the profession.

With all the legal strictures at play, the big question to be pointed to the regulators is how approvals are granted to brazenly faulty trial protocols. Does India have the right machinery ready to allow or investigate the minute nuances of clinical trials? Are there examples of strict punitive action against sponsors, CROs, investigators or ethics committees where clinching evidences are found? Is merely registering for clinical trials sufficient to ensure patient safety? How effective are the compensation norms for patients affected by trials?

While there are legitimate concerns on the quality of clinical trials in India, we have to also admit that clinical trials on drugs are necessary to investigate new drug discoveries and bring in latest treatments. And for that there are a handful of serious players who seem to be following the ethical practices. For the fault of a few, can all the investigations be treated harshly?

As it stands now, select CROs vow to follow all the norms in the book but having faced the flak from past errors in approval processes, regulatory agencies are in a pause mode for long. For those with mounds of luck, trial approvals have taken over eight months and for others there an eerie uncertainty remains. Being cautious in granting approvals is ideal but to keep the industry on its toes without elaborate reasons is an ominous signal to exit their projects in India.

That would not only be enormously damaging and negative for the Indian industry, but also, and more importantly, the move may not be beneficial for the Indian patients. For any drug to be efficacious on the Indian population, it is important to have the right representation in global trials for cutting edge products.

At the same time, there cannot be anything more unfortunate than that a drug meant to save lives leads to controversial deaths. And there cannot be a lasting solution unless all stakeholders make a serious commitment to patients by following ethical international guidelines. To risk the lives of helpless patients merely to push commercial interests is nothing short of an act of crime. The guilty must be debarred and punished and that should be the utmost task of authorities.