restricted access Clinical Trial Subjects in India—Lessons for Asia
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Clinical Trial Subjects in India—Lessons for Asia

Through this editorial, we call attention to the broader implications of the issues mentioned in the paper of Nadimpally, Ambhore, Venkatachalam and Bajpai regarding the experiences of clinical trial subjects in India. The issues are not really new, although the paper discusses them in relation to policy changes made in that country and in the context of clinical trials viewed from the perspective of trial subjects. It is not because the issues are new that they are worth revisiting. On the contrary, the issues deserve renewed interest because they are quite old and yet they continue to put a cloud on efforts to protect the interests of human subjects of clinical trials. The issues also affect people in many countries, including India’s Asian neighbors.

Among other things, the paper highlights the decision of some patients to enroll in the clinical trials because they cannot afford available treatment for their disease or medical condition. Although there were subjects who spoke of being motivated by an altruistic desire to help the patients themselves if the drug being tested in the clinical trial proved to be beneficial, “free treatment” proved to be one of the strongest factors influencing the decision to participate. One informant spoke of the lure of receiving free treatment for one year while others spoke of the high cost of alternative treatments. The subjects’ focus on the availability of “treatment” indicates that therapeutic misconception was pervasive. The therapeutic misconception perhaps has been heightened by the hierarchical relationship that exists between physicians and patients as illustrated in a respondent’s decision to participate because of a feeling “that the doctors were offering him a service, and doing him a favour, and hence … that he should not ask too many questions.”

Trust in the medical profession is obviously important as it gives patients and research subjects the necessary confidence: “The doctor and the [End Page 293] coordinator gave their phone numbers to me, so that in case of any problem I could get back to them. They were very friendly.” However, such trust could occasionally be misplaced and even exploited by the unscrupulous. One respondent reported being promised “free check ups and tests for all the health problems” only to realize that after giving consent “only a test for cancer” would be done.

As the paper says, the trust that patients put in the medical profession is so strong, making it “difficult for physicians to make the distinction between a clinical trial and treatment adequately clear to patients.” At the same time, the hierarchical trust in doctors raises concerns about the nature of consent: “Such enrollment of CTSs in clinical trials is due to the undue influence of the doctor on the patient. It definitely raises questions on the voluntariness of consent and informed consent of the participants of the clinical trial [inasmuch as] … doctors play a major role in influencing the CTSs to participate in the trial. Such practice of doctors is not only unethical but also in conflict of interest to the treatment interests of their patients. There appears to be a conflict of interest between the personal interest and professional responsibilities of the doctor who is in a position of trust.”

In general, the paper observes that “economic conditions of the CTS along with high costs of treatment appear to play a major role in influencing their decision to participate in a clinical trial.” In addition, the paper notes that “more than 50% of the CTSs are not well educated and have just completed their secondary school education, and do not have well paying jobs or sources of income to cover their costs of treatment and health care, including diagnostic testing costs. All these factors increase their vulnerability … in clinical trials.”

The paper also points out that structures and processes intended to ensure the ethical implementation of clinical trials are being put under pressure by a strong pharmaceutical lobby coupled with the Indian government’s predisposition to outsource and privatise clinical trials. In a way, such structures and processes effectively become the battleground for a conflict of interest between the government’s pursuit of economic interests...