Clinical trials in pediatrics-review of ethics and law


  • Anitha P. Department of Pharmacology, Sri Siddhartha Institute of Medical Sceinces, T. Begur, Karnataka, India
  • Ruchi Dhar Department of Community Medicine, Sri Siddhartha Institute of Medical Sceinces, T. Begur, Karnataka, India
  • Narayana Krishnappa Department of Pharmacology, Sri Siddhartha Institute of Medical Sceinces, T. Begur, Karnataka, India



Pediatric clinical trials, Law, Ethics


Children were acknowledged as ‘therapeutic or pharmaceutical orphans’ in 1960s, since then there has been a worldwide recognition of the need to conduct clinical trials in children, to improve their health. Prescribing in children is often based on extrapolation of trial results from adults, due to the lack of paediatric data. Children have different pharmacokinetic and pharmacodynamics responses as compared to adults. Hence extrapolating the adult safety and efficacy data and using it for prescribing in children can have disastrous effects. Relevant literature on clinical trials in paediatrics was gathered and scrutinized with emphasis on legal and ethical perspectives. This research is an exploratory attempt which surveys and summarizes previously published studies simultaneously trying to answer few research questions which addresses the current debates and scenario. Common problems encountered during pediatric clinical trials are unnecessary scrutiny of even minimal risk studies, difference in interpretation of research protocol in multicentre trials causing delay in trials, prolonged review process. The proposed changes to overcome the above mentioned drawbacks are standardized data security protections, enforcing universal ethical principles for conducting pediatric trials, sstandardizing adverse drug reaction reporting to regulatory bodies. There is a need to increase the number of clinicians actively involved in pediatric research. All the stake-holders such as regulators, parents, ethics committees, research institutions, investigators, sponsors, media, pharmaceutical companies and scientists have to collaborate to ensure that ethical pediatric research is promoted, equipping them with knowledge needed to provide optimal care to their patients.

Author Biography

Anitha P., Department of Pharmacology, Sri Siddhartha Institute of Medical Sceinces, T. Begur, Karnataka, India


Associate professor


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How to Cite

P., A., Dhar, R., & Krishnappa, N. (2022). Clinical trials in pediatrics-review of ethics and law. International Journal of Basic & Clinical Pharmacology, 11(5), 538–544.