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P117: Where are the Pediatricians in Clinical Research?

Poster Presenter

Jacqui Whiteway

Senior Director, Centre for Paediatric Clinical Development
ICON
Canada

Objectives

Evaluate the proportion of pediatricians in the USA that have clinical trial experience and assess if there are enough research experienced pediatricians to support clinical trials in the USA, or if an unmet need is the lack of clinical trial experienced pediatric investigators.

Method

Clinical trial data from Citeline, TrialHub and clinicaltrials.gov were used to determine the number of recent industry sponsored trials conducted in the USA that involved children, and claims data were used to determine the total number of pediatricians and specialties.

Results

According to data from medical and hospital claims data, 11,994 (8.7%) of the 137,941 research-experienced physicians in the USA are pediatricians. Of the 96,388 physicians with a specialty description of “pediatrics” (no other specialty noted), only 4,126 (4.3%) are research experienced. The pediatric sub-specialties with the greatest number of experienced investigators are, in order of greatest to least: Hematology/Oncology, Psychiatry, Neurology, Endocrinology, Cardiology, and Gastroenterology. The specialties with the highest proportion of research experienced compared to research naïve investigators are: Hematology/Oncology, Endocrinology, Neurology, Gastroenterology, Cardiology, Psychiatry. Only hematology/oncology has greater than 50% of experienced physicians. As expected, the total number of research experienced physicians in the top therapeutic areas for adults (39,965) is much greater than for those in pediatrics (5,258). The proportion of research experienced investigators for trials with adults in each therapeutic area is similar, though greater, especially for cardiology, than for pediatrics; the exception is endocrinology where a greater proportion of pediatricians are research-experienced than adult physicians. There have been 13,398 Industry sponsored trials in the USA in the past 5 years. 1,536 (11.5%) of these trials included pediatric (0-18 years old) participants. Similar to adults, the greatest number of industry sponsored trials with pediatric patients are in: Hematology/Oncology, Neurology, Cardiology, Endocrinology, Gastroenterology, and Psychiatry. Using TrialHub we analyzed 75 industry sponsored clinical trials completed within the past 5 years in the USA that included only pediatric patients for which recruitment data were available: 80% of the trials underperformed, with an average patient recruitment delay of 254 days, and on average 55% more sites were added to achieve trial completion.

Conclusion

About 8.5% of research experienced physicians in the USA are pediatricians; however, ~11.5% of trials in the past 5 years have been conducted in children, and this is expected to continue to increase due to efforts by the FDA and other regulatory bodies, such as by the RACE for Children Act2,3. Overall, clinical trials underperform with regards to actual versus planned recruitment targets and timelines, and this appears to especially be the case for trials that only include pediatric participants, where 80% of industry sponsored trials in the last 5 years in the USA underperformed across all therapeutic areas, resulting in the addition of 55% more sites on average, compared to 30% for trials with adults only. Pediatricians with subspecialties have the greatest proportion of research-experienced physicians, especially in hematology/oncology where 52% are research-experienced, while only 4.3% of pediatricians without a subspecialty are research-experienced. While there are many factors involved for planning the number of sites in a trial, it is often restricted simply due to the number of experienced investigators. Planning for more sites at clinical trial initiation should lead to shorter timelines, but this is only possible if there are physicians with the appropriate therapeutic and trial interest and expertise. The paucity of physician-scientists has long been a concern4 and attempts to boost the number of pediatricians in research have had some impact, particularly research training and mentorship during residency. With over 90,000 research-naïve pediatricians, there is potential for a more diverse and extensive supply of investigators More research is needed, particularly to identify industry experienced physicians as well as how to get more pediatricians interested and experienced in clinical research.