This report details the background scientific, ethical and regulatory issues that prevent full realization of the benefits of conducting clinical trials of the effects of interventions. It details strategies to overcome these obstacles and to increase prospective registration of clinical trials in India, particularly those recruiting children.

Section 2 details the critical issues that need to be considered in the design, conduct and reporting of clinical trials of the efficacy and safety of interventions used in healthcare and highlights the need for good quality trials and systematic reviews in addressing healthcare questions of local relevance in providing reliable information for evidence-based health decisions.

Section 3 details the scientific rationale for and the ethical issues involved in conducting clinical trials in children and provides an ethical framework by which these trials can be measured.

Section 4 provides an overview of the legal and ethical regulatory framework that governs research in India and clinical trials in particular.

Section 5 summarizes the importance of prospective clinical trials registration and its role in preventing publication bias and selective reporting and contextualizes trials registration against the backdrop of the quality of design and conduct of clinical trials.

Section 6 details the activities and progress of the Clinical Trials Registry- India CTRI) and its attempts to improve the registration of clinical trials and also improve the quality of design of such trials. It provides details of trials registration on the CTRI that are pertinent to this report.

Section 7 discusses eight strategies and 14 options for action that will increase the number of trials, particularly those recruiting children in India, in the CTRI and a summary of these strategies and options with the likelihood of success and importance to this report are provided in Appendix 6 in Section 14.

Section 8 provides a detailed reference list to articles cited in this report.

Section 9, Appendix 1 reproduces the terms of reference of this report.

Section 10, Appendix 2 provides a draft of a proposed amendment in the ICMR bioethics guidelines endorsing trials registration in the CTRI that will increase the likelihood of clinical trials registration. This forms one of the proposed options to pursue among the list of suggested strategies aimed at increasing the number of trials recruiting children registered in the CTRI.

Section 11, Appendix 3 provides the draft of a performa for surveying ethics committees regarding approval for trials recruiting children.

Section 12, Appendix 4 provides the draft of a performa for surveying researchers conducting clinical trials recruiting children

Section 13, Appendix 5 provides the contact details of key stakeholders that will improve the chances of success of this project and a list of web-addresses of key resources that will be essential for the activities under this project.

The views expressed in the report are entirely those of the author and do not necessarily reflect that of any of the organizations of individuals named in this report.