Insights into Editorial: For a wider pool
A growing number of people are over-volunteering for clinical trials in order to supplement their income. There is a disturbing trend that is putting at risk the health of serial volunteers as well as the reliability of trial data.
In May 2017, 53-year-old from Telangana state, who volunteered for the trial on a bio-equivalence study, to compare the biological behaviour of an unapproved formulation of melatonin with an older one, was died.
Financially needy people serially volunteer for trials to supplement their income. This is a worldwide phenomenon, including in high-income regions like the U.S. and the European Union.
The problem arises when volunteers who are desperate for money deceive investigators, lying about their age, health or other medications, just so they can participate.
Such serial volunteers are an especially vulnerable class of people, because of their poverty and low levels of education.
Under the Indian Drugs and Cosmetics Act, an independent body of doctors and laypersons, known as an ethics committee, must oversee a trial to make sure the rights of such groups are safeguarded. But bioethicists say this isn’t happening.
What are Clinical Trials?
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. Before a drug is launched in market, it has to be tested for its safety and efficacy. This is done in stages, with a large pool of patients after which the data from the trials is assessed.
In India, Central drug Standard Control Organisation (CDSCO) regulates under Drugs and cosmetics Act.
India has been a preferred destination due to the availability of large genetic pool with a wide spectrum of diseases, educated work force and lower operational costs.
Ethical considerations to be followed whle conducting clinical trials
- Informed consent and Voluntary Agreement of the participant
- Maintain privacy of the participant
- Accountability and transparency while conducting trials
- Research and trial details should be in public domain.
Prevailing Issue in India
The major issues w.r.t Clinical trials in India are Regulatory failures, Unethical clinical trials, spurious drugs, Collusion between drug companies and doctors.
Landmark amendments to the Drugs and Cosmetics Act in 2013 led to better protection of vulnerable groups such as illiterate people, but more regulation is needed to ensure truly ethical research.
Clinical research organisations (CROs) have argued that more rules will stifle the industry; the truth is that ethical science is often better science. The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects.
Sometimes CROs recruit them selectively, exploiting financial need and medical ignorance; at other times people over-volunteer for the money.
Because these subjects are well-paid, and get no therapeutic benefit, their only reward from the trial is financial. This results in an incentive to lie about one’s medical history or enrol in multiple trials to maximise one’s income.
Protecting the vulnerable
In any trial that relies heavily on vulnerable groups like daily wage earners, the ethics committee can choose to monitor subjects intensively, and counsel them on health risks. There are several tools to do this, like meeting participants and administering questionnaires to gauge their awareness.
The pervasiveness of serial volunteering and deception is not just a risk to participants but also taints the quality of data collected by CROs in bioequivalence studies. Unsafe drugs can make their way into the market as a result, or safe drugs can get rejected.
- One potential solution is a national registry of trial volunteers, which will alert a CRO when someone signs up for two studies simultaneously without compromising volunteer’s privacy.
So regulators need to create a system that anonymises each participant’s data.
- Another option is to pay volunteers less, taking away the financial incentive to fudge their participation history. But this measure, in isolation, would reduce trial participation dramatically: an unacceptable side-effect because clinical trials are essential to drug research. A third, more sustainable solution is to encourage a wider cross-section of society to participate in research on human subjects.
Compulsory registration of all clinical trials before any dosing starts. This will help in stopping illegal trials. Audio visual recording of informed consent in trials is important. Ethics committee of the Institute must also be accredited (recommendation of Ranjit Roy Choudhury Expert Committee)
Society at large must realise the valuable service that clinical research subjects perform by making drugs safe for the rest of us. Civil society’s vigilance is vital.