JOURNAL OF CLINICAL AND BIOMEDICAL SCIENCES

Abstract

Background: Studies have shown that recruitment is the main limiting factor for conducting clinical trials in children. Reports from the Western nations revealed that parents enroll their children in clinical trials mainly due to altruistic reasons. Hence, the present study has been envisaged to evaluate the factors motivating parents to allow their children to participate in clinical trials from a developing country. Methods: The present study was conducted in a tertiary care university private hospital amongst the parents whose children had participated in any of the three clinical trials that were conducted between 2003 and 2007 in the same centre. A pre-validated structured questionnaire consisting of both open- and close- ended items was used for the study after obtaining permission from the author of the questionnaire. The completed questionnaire was then analyzed using descriptive statistics. Results: : Of the 136 parents identified from the earlier trials, of which 44 parents participated in the current study. Of these, 36 (81.8%) parents remembered the process of consenting for their child and reported that they had enough time to make their decision and 38 (86.4%) parents felt that they had received sufficient information in the clinical trial they had participated. The parents provided multiple reasons for enrolling their children in the research study. The most commonly stated reason was “contribution to science” (41, 93.2%), followed by ‘benefit for their child’ (40, 91%). A total of 40 (91%) participants stated that they felt obliged to participate in the trial. Only two (4.5%) of the participants mentioned that they felt any disadvantages in participating in the clinical trial. Only 24 (54.5%) parents had reported that they would take part in a similar study if invited in the future. Conclusion: In conclusion, it appears that majority of the parents in India enroll their children in trials for the reason that are similar to those in developed countries. However, studies on a larger sample and in trials of a varied nature are needed to confirm our findings.

Key words: Vulnerable population, children, pediatric clinical trials.