Motivating factors for recruitment of children in clinical trials

Historically, the pharmaceutical industries, regulators and society have been averse to the idea of exposing children to new drugs by enrolling them in clinical trials. However, this attitude has led to rampant off-label use [1,2] whereby children are exposed to drugs whose safety, efficacy and dosage schedule has not yet been determined. This has led to a rethink on the part of scientists and regulators who are now, in fact, insisting on conducting clinical trials in children for drugs intended for use in them. This has resulted in an enormous increase in the number of pediatric trials. [3] It is believed that parents are generally reluctant to enroll their wards in clinical trials and this is associated with a slow recruitment rate. [4-8] Some studies have tried to determine the reasons for why parents enroll their children in clinical trials; however, most of these studies have been carried out in developed countries. [9-11] Despite many challenges in conducting clinical trials in India, [12] it remains a preferred country for clinical research and it is likely that more pediatric studies would be carried out here. Given the differences in income, educational level, and literacy rates between India and the developed world, the reasons why parents would want to enroll their children in trials could be different here and hence the present study was undertaken. Introduction: 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 …