Title : Understanding the issues with recruitment in pediatric clinical trials in India as cited by key stake holders and to draw down the strategies for better recruitment
Abstract:
A steep rise is seen in conduct of clinically trials not just globally but in India as well over the years. Through this pharma industry is striving to serve high-quality treatments and procedure options catering to all classes of populations and including those for complex diseases at affordable prices. Being said these trials in pediatric population still remains a challenge as major reason for this is low recruitment and retention rates. For prolonged times pediatric population have been excluded from clinical trials conducted globally as well as in India. It was observed that various treatments and procedures which are used for pediatric population have not undergone clinical trials. In recent times various regulations and guidelines have been laid to conduct clinical trials in pediatric population. Despite of this the major reasons disturbing or delaying enrollment in clinical trials is that the parents or legal guardians being primarily involved in decision making, concerns also arises with regards to the safety and benefits to the participating child in the study. Researchers have also identified certain other factors like study design, procedures involved, indication for the development of study drug, patient characteristics that contribute to low recruitment as well. It is necessary to overcome the enrollment issue to conduct an appropriate clinical trial which would further help in having the right effective treatments to pediatric population. Understanding the said situations, the study was designed to understand the concerns and prospective as well as the reasons from various group to evaluate the problem and filter down to the solution. A survey was designed to understand the barriers and facilitators responsible for enrollment in pediatric clinical trials. One of the group for the study was of clinical research (CR) professionals who are in forefront of planning and execution of trials. Next was of site personnel who have firsthand experience with the management of the subject population. And the final group of parents with children less below 12 years of age as they would be the decision takers. The data was collected and analyzed, and it was observed that 100% of the site and CR personnel found pediatric recruitment challenging. More than 70% CR & site professionals agreed that limited scientific literacy in the general population is responsible for narrowing the chances of patient enrollment in pediatrics trials. More than 80% of CR & site personnel see moderate to very high chances of a child's primary physician referring their pediatric patients to a clinical trial but being said around 80% consider informed consent and assenting process to majorly impact pediatric recruitment. Media is considered to have a positive to extremely positive impact as per 50% site personnel. 75% of parents agreed to having heard about clinical research of which 61% parents would allow then child to participate in a trial provided the child in willing to participate on its own. Overall, it was understood that more awareness in general population will help in better recruitment
and retention in pediatric clinical trials.
