Kaushal Kapadia* & Deven Parmar

ABSTRACT

Objective: To understand perspectives of parents whose children are going to participate in clinical research in India. Design: A survey in the question-answer form was carried out covering child participants and their parents from different parts of India. Questionnaires were filled with the help of investigators, physicians, social workers, freelancers, and research professionals, etc. Methods: Clinical research in children is more challenging than those in adults. Physiological and anatomical conditions of child and that of adult are different. Therefore disease condition and their treatments are also varying from that of adults. This study has major focus on the awareness and perspective of Indian child participant and their parents towards clinical research. Also, child participants are provided with proper treatment as well as safety of the child is always remaining the top priority. Results: There were 28 different parameters/data points for which the data was collected from 1180 parents across the country. As the available data is dichotomous a dynamic analysis was done using a percentile method. Conclusion: In India, regulatory health authority such as the Central Drugs Standard Control Organization (CDSCO) – the office of the Drug Controller General (India), set the necessary guidelines & schedules for ethical conduction of clinical trials, but the parents understanding towards it is also important. This analyzed data concludes that awareness of parents regarding the trials and child participation is relatively low. A better knowledge and awareness towards trials will build advancement of paediatric medicines in positive way.