The ever-growing demand for new drugs to ward off continuously evolving strains of diseases like AIDS, meningitis, hepatitis makes investment in Clinical trials very important for the present as well the future public health and well-being.
However, out of a thousand new molecules discovered, only one has the potential to be an effective and viable drug. Each new molecule discovered thus goes through a variety of tests. One of them is testing the molecule’s toxicity and effectiveness on humans; for testing this, clinical trials are performed on human ‘subjects’ or participants. Many pharmaceutical companies of developed countries have taken up such biomedical trials and research to develop new drugs.
Due to such increased demand, the pharmaceutical industry is pushing for conducting more and more clinical trials. This requires a large and diverse set of volunteers. The awareness and stricter regulations in developed countries, as well as costly research as compared to developing or underdeveloped countries, make it hard to enrol volunteers in large numbers for such trials in developed countries. Therefore, these multinational companies from the wealthy, developed nations off-shore stages of their research to developing or underdeveloped countries like India (According to the Drugs Controller General of India (DCGI) out of all the registered clinical trials being conducted in India, 72% are carried out by the pharmaceutical industry) which proves to be an excellent site for research at significantly lower costs, developed medical infrastructure and trained, English-speaking human power. India also sports a large, diverse and treatment-naive (untreated) population with six out of the seven genetic varieties of the human race.
It is a very noble act on part of the participants but sometimes these trails turn detrimental for them and harm them due to carelessness of the researchers, weak ethics or the incomprehension of the trial’s documents on the part of the participants. Several studies and reports on drug and vaccine trials have suggested a presence of many such unethical and illegal practices which ends up injuring the participants. The involvement of off-shoring and foreign companies, lack of public evidence, high costs of litigation, and cultural-logistical issues make it difficult for participants to hold them liable in case of infringements of their rights or when an injury is caused to them due to these trials. Further, the researching foreign countries differ vastly in terms of language and culture from the host country. This naturally entails the requirement of localization of the trials in the host countries as well as translating the consent forms, the term and conditions containing the dos and don’ts and the risks involved with the trial in the language spoken or used in the foreign country. This gives the clinical translators supreme importance as without them, the implementation, as well as the interpretations of the results by the manufacturer or the researcher, will be impossible.
The consequences of inaccurate translations can be very serious. It, on one hand, costs the comprehension on the part of the one volunteering for the test. Due to this, the participants fail to understand the risks and the side effects of the trial and don’t act according to the prescribed ways before or after medical intervention. There is a disparity in the administration of the drug and the likelihood of follow-ups and treatment of the side effects or underlying conditions reduces significantly as the participant fails to connect such side effects with these trials. It might even lead to serious health impairments and participant fatality in the worst of cases. All this affects the participant physically, emotionally as well as financially. In some cases, even if the participant goes for the treatment of these side effects, he/she ends up spending more money than he/she had originally received from the trial afterwards for their deteriorating health due to the trials.
In India, majority of the research participants are constituted by the poor, weak, illiterate or marginalized literates and the vulnerable who cannot afford costly treatments of chronic diseases who are there for free medical treatment, nutritious food/dietary requirements and monetary incentives provided for participating in the trails. Due to the widespread illiteracy and unawareness among this group, it remains quite questionable if they really understand the terms and conditions and the risks & the benefits associated with the trials due to the limited knowledge about the concept of clinical trials and having no prior experience with such trials. Obtaining meaningful and informed consent and making sure that the participants understand everything about the trial becomes complicated and tedious in such setups.
On the other hand, it may lead to wrongful interpretations and conclusions on the part of the researcher, impairing the effectiveness and the validity of the trials.
Many such foreign companies often carry out these trials improperly and in a sub-par manner due to limitation of money and resources and our weak laws allow them to do so. The policies regarding the matter are very lenient as there is a lack of specific legislation and law relating to biomedical ethics. This helps the companies escape the difficulty in recruiting volunteers for the trials due to limited population base, high costs and strict bureaucratic regulations and legal accountability in the west. Another problem is that Indian government is aggressively promoting such trials to be conducted in India for getting inflows of foreign investments without first properly setting up policy frameworks and mechanisms to inspect such trial sites; audit clinical trial data and regulate them in public interest, whenever required.
This problem is further intensified by the poor readability of consent forms and a hard writing style, filled with technical terms, difficult grammar and the tendency of the researcher to hammer out every detail legally and factually so that later on, no loopholes can be found in such consent forms, holding him in a vulnerable position. In India, informed consent also suffers when doctors ask their patients to sign up for such trials as the pharmaceutical companies offer them incentives and perks for encouraging their patients to do so, leading to a serious conflict of interests, detrimental to the well-being of the patients.
The trials conducted on human beings are held to be fair by the whole world in name of ‘beneficial research’ but there is an inherent cost that India bears; the human cost; the one which the poor, weak and the vulnerable population of India bears. It is reasonable to say that while these trials cannot be stopped altogether but can at least be regulated. The rampant, unregulated conduct of trials can definitely be regulated effectively through a decent, ethical and moral framework of laws and regulations. The terms of the trials must be simplified and be clearly explained to the participants and special care should be taken in cases of the old, poor and illiterate; comprehension and informed consents should be a continuous process rather than a single event.