India is becoming an important destination for paediatric clinical trials. Out of the total 600 trials conducted so far in the country, 10 per cent constitutes studies on children and the number is growing, according to the Association of Clinical Research Professionals (ACRP).
Going by the large paediatric patient pool in the country and increasing number of tropical and infectious diseases, the country is proving to be a major hub for global pharma majors to conduct trials on children. But conducting and completing a clinical trial on paediatrics is a huge challenge for clinical research organizations and hospitals. These included identification of the right case, seeking informed consent not only from the parents but also approval from the child who most often refuses drug administration and minimizing distress during analysis.
In order to highlight and educate clinical trial students and professionals, a seminar on Paediatric Clinical Trials was organized by the ACRP and Bilcare Research Academy.
Paediatrics are not miniature adults but are a vulnerable sub-group, stated Dr PP Maiya professor and head, department of Paediatrics, MS Ramaiah Medical College who has been associated with over 30 trials on children.
Paediatric trials are essential for pharmacokinetic studies and to assess the safety and efficacy of the drug. Delving into the issues and challenges of paediatric studies, Dr Maiya said that children have a unique path physiology and response to therapy. There is immaturity of renal and hepatic clearance mechanisms, protein binding and displacement issues together with transdermal absorption the drug.
In the case of infants, the blood-brain barrier is not formed. There is also the concern about volume of distribution of drug which is different from those in older paediatrics because of different water, fat content and high body surface area to weight ratio.
In the case of adolescence, which is a period of rapid body growth, although most pathways of drug clearance are mature, yet there is an apprehension about the after effects of the drug. Puberty phase is known to affect the activity of enzymes which metabolize drugs and its interface with the actions of sex hormones could impede development, said Dr Maiya.
For easier consumption of paediatric formulations, along with accurate dosing, it was also crucial to ensure that the drug was palatable. Therefore flavours and colours played a key role for easier consumption. The toxicity of some drugs would also vary across age-groups. For instance, Benzyl alcohol is toxic in preterm newborn.
Friendly and familiar environment supported by knowledgeable and skilled medical experts to handle children were important to conduct the study. In order to minimize the distress, use of topical anaesthesia to place catheters and in-dwelling catheters preferred over repeated veni-punctures for blood sampling are recommended.
Other issues included recruitment, reimbursement and compensation. Although consent of either parent was legal, yet it was recommended that both should give permission. There are also instances where parents sought permission from the elders in the family and consent for the trial was declined.
Literacy of the parents is viewed as a double edged sword. Investigational sites were on the look out of semi literate parents who could understand the basic details of the trial.
Dr S Medha Joshi, principal, Bilcare Clinical Research Academy, Bangalore provided an overview of the guidelines for conducting clinical trials in the paediatric population. Schedule Y called to begin trials on older children, extend it to the younger age groups before infants were included in the study.