Think clinical trials and the popular notion is that of human guinea pigs being subjected to unethical research practices. So, should India stop clinical trials? Dr Viraj Suvarna plays the devil’s advocate.
The first global trials were conducted in India around 20 years ago by global research-based companies, who have a strong focus on ethics, quality and compliance in the way they conduct trials.
Their standard operating procedures are even stricter than the law of the land. They regulate themselves even more stringently than the applicable local regulatory requirements. Why? Because they have the most to lose.
Millions of dollars are spent in doing a trial appropriately. Naturally, it is in a company’s interest to do the trial correctly so that the data is credible and patient safety is not compromised. They stand to lose the most if falsified data is the basis for approval.
If a drug has to be later recalled from the market it is the company who faces the worst backlash, not only in terms of financial loss - which one can recover from - but in terms of integrity, trust and corporate reputation, which once sullied can never come back. The sponsor needs to know at the earliest if the drug is not effective or is not safe so that the same can be discontinued as soon as possible.
Clinical research begins with identifying an unmet medical need and a target. The best fit molecule then goes through many years of testing in various laboratory and controlled conditions before it is deemed effective and safe enough for trials on healthy volunteers and patients. Clinical trials are conducted in four phases.
Trials at each phase help researchers answer different questions with respect to a drug’s safety and efficacy.In India, if innovator drugs have to be marketed they need to have safety and efficacy data in a minimum number of Indian patients.
When Indian patients are included in a global clinical development programme for the drug, it helps in two ways - eligible Indian patients benefit from the drug at the same time as patients from the rest of the world, and this data can then be used to seek expedited approval from the Drug Controller General of India (DCGI) so that other eligible Indian patients can also benefit.
In India, if innovator drugs have to be marketed they need to have safety and efficacy data in a minimum number of Indian patients. When Indian patients are included in a global clinical development programme for the drug, it helps in two ways - eligible Indian patients benefit from the drug at the same time as patients from the rest of the world, and this data can then be used to seek expedited approval from the Drug Controller General of India (DCGI) so that other eligible Indian patients can also benefit.
Clinical trials in India - as in the rest of the world - are carefully monitored. Selection of the investigator and site, based on specific criteria, is paramount. Training of the investigator and site staff is important, as are regular monitoring visits, quality checks and audits. Ethics Committees review and approve protocols as well as visit sites to ensure compliance. Regulators refer protocols to academic experts before approvals.
Informed consent is administered as a process. It is a robust and rigorous process, not a mere signature on a document and is done in a language that the patient is most comfortable with.This document is written at a level that can be understood by a lay person and is approved by the Ethics Committee overseeing the study.
It is signed by the patient and the doctor prior to the subject’s participation in a study, and a copy of the signed form must be handed over to the patient to keep.
If the patient is unable to read/write, the study doctor provides all the information verbally and an impartial witness needs to be present during the entire informed consent discussion and must sign the informed consent form indicating that all necessary information was provided to the patient.
Clinical research, in short, is a complex and robust process, from which we gain insights and answers about the safety and effectiveness of drugs and therapies. So what if trials don't happen in India? Indian patients will continue to be treated with the existing standard of stagnating care while the world would have moved on to better medicines buoyed by innovation.
Indian patients will be excluded from this wave of change. If innovation is killed, no new drug will be evaluated in trials and no copy or generic will be manufactured using another process. Patients will not have access to new and better treatment.
Our doctors and scientific researchers will not have the opportunity to be involved in medical breakthroughs. Indigenous innovation will dry up. Our health statistics will not improve. A patient’s only hope to get better may be stuck in a never-ending queue. (The author is an MD in Pharmacology and member of executive council of Indian Society for Clinical Research)