Quality of informed consent in cancer clinical trials in India: A cross-sectional survey.

Background: An 'informed consent' is a legal and ethical requirement for research involving human subjects. Studies assessing the validity of informed consent and determinants of its quality have highlighted problems in consent delivery and comprehension by trial participants. We report the findings of a questionnaire-based survey conducted to understand the quality of informed consent (QuIC) in cancer clinical trials.

Methods: The survey was conducted in a single tertiary care cancer centre in India. Patients enrolled in phase 1, 2 or 3 interventional studies were administered the QuIC questionnaire by a trained study coordinator. The QuIC, expressed as knowledge score, was calculated from the proportion of correct responses expressed as a percentage.

Results: The mean (SD) knowledge score was 60.46% (1 5.21%). It was considerably higher in industry-sponsored trials compared to investigator-initiated trials (65.32% v. 52.21%, respectively; p<0.001). Faith in the treating oncologist positively influenced the patients' decision to participate in a trial. Nearly 97% of the respondents anticipated better care, while 85% felt that the new drug/procedure would be better than the existing treatment. Free treatment emerged as a strong inducement for patients to take part in clinical trials. Patients were aware of their autonomy, and responses showed that none of the patients were coerced or unduly influenced to participate in clinical trials.

Conclusion: Our study revealed important deficiencies in research participants' understanding of essential elements of informed consent. Thorough patient counselling is crucial to minimize 'therapeutic misconception' to preserve the validity of informed consent in cancer trials.