NEW DELHI: The lure of free treatment is the biggest reason why around 60 per cent of cancer patients in India agree to undergo clinical trials — with no guarantee of safety or efficacy.
The study titled “Quality of informed consent in cancer clinical trials in India: A cross-sectional survey” — conducted by Tata Memorial Centre (TMC) in Mumbai and Public Health Research Centre, New York — revealed that although 74% claimed that altruism was one of the reasons for participation in the trials, all respondents anticipated some benefit from participating in them.
“With a mere 15 % of patients being covered by health insurance, free treatment is a powerful inducement,” noted the study based on interviews of around 200 cancer patients at the TMC. The study was published in The National Medical Journal of India.
These patients had undergone phase 1, 2 or 3 interventional studies of pharmacological, surgical or radiation therapy, either sponsored by the pharmaceutical industry or initiated by investigators.
“Thus, the basic tenet of ‘no inducement’ adopted by good clinical practical guidelines is challenged even by the legitimate practice of providing free treatment on trials.”
As nearly 10 lakh new cancer cases are detected in India every year, the study has thrown the spotlight on financial and emotional vulnerabilities of families battling cancer.
The study also highlighted that many patients tend to consent for clinical trials solely because of faith in their oncologist.
“This could allow possible ‘exploitation’ of patients, especially if the oncologist, although meaning well for the patient, has a greater inclination towards the research goals,” noted the research.
“The validity of informed consent in these circumstances becomes questionable.”
Vikram Gota, lead researcher and a pharmacologist at the TMC said the hope of better care and the ‘belief that the new drug would be better than the existing treatment’ were the major factors driving patients to participate in a cancer clinical trial.