Management of Pediatric Clinical Trials Calls for Urgent Technological Innovation
MANASSAS, Va. (PRWEB) February 14, 2022 — As the number of pediatric clinical trials show signs of improvement, how to best sustain and scale them comes into play. Dr. Harsha Rajasimha of Jeeva Informatics addresses the challenges in making radical improvements in pediatric CT operations.
Changes in legislation, increased interest in pediatric studies by the pharmaceutical industry, and a renewed interest in rare diseases have increased the demand for clinical trials (CT) of investigational medicines for children. Nonetheless, pediatric clinical trials continue to have a very high failure rate.(1) Many of the problems affecting pediatric clinical trials, says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics and Founder Chairman of the Indo US Organization for Rare Diseases (IndoUSrare), have to do with the way trial participants are recruited and managed. “You cannot conduct a pediatric CT the same way you would with adults.” says Dr. Rajasimha. “Fortunately, improvements in both understanding and technology are enabling a better process—which, in time, should lead to better results.”
One persistent challenge in pediatric CTs, notes Dr. Rajasimha, is that children are not free agents. Informed consent requires that the participants’ parents or guardians understand what is at stake. There is also a whole subset of logistical issues, given that children are dependent on their parents’ transportation and work schedules. Perhaps the most satisfactory solution, Dr. Rajasimha says, is telehealth: enabling both children and their parents to participate in the study from home, via today’s now ubiquitous digital platforms.
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