Timeline for site onboarding for an nih funded clinical trial in pediatric gastroenterology & nutrition: Ikaneat

ABSTRACT

Prospective multicenter center studies are needed to develop inter-institutional clinical pathways and improve health care practices. Multicenter studies are encouraged by the National Institutes of Health and desired by investigators. However, investigator-initiated, randomized, controlled, multi-site trials face many challenges1, one of which is the timeline involved in contracting, regulatory and human subjects' requirements. These steps must be finalized prior to each site's activation to engage in any study-related activities. Research indicates these timelines can be especially challenging for pediatric trials, and trials involving medically complex patients.2,3 Given the typical investigator-initiated funding cycle of five years or less, understanding the timeline necessary to achieve multi-site activation is key to the conduct of multi-site trials, especially trials that are complex. Therefore, the purpose of the current analysis is to present the timeline for site activation across nine sites in the United States participating in the iKanEat trial (NCT03815019;NIH R01 HD093933) from October 2018 thru present. iKanEat is a prospective randomized controlled trial conducted across 10 sites in the United States focused on the use of megesterol as part of a pediatric tube weaning program. Data were collected from the regulatory system at the primary site regarding the variables of expressing interest, IRB approval, contract approval, site activation, and first subject recruited. Data indicate that time from expressing interest in the study to full IRB approval averaged 230 days (range = 70-396) and time to full contract approval averaged 190 days (range = 88-190). The time for clearing all administrative hurdles and moving to full site activation for subject recruitment averaged 288 days (range = 253-350) and the time from site activation to consenting a first patient to the study averaged 463 days (range = 314-669). Reasons for delays collected from each site included coordination with the investigational pharmacy, site accounting set up, and scheduling site trainings with the investigative team at the primary site. It is also likely that the outbreak of SARS COV-2, and subsequent pauses in site activities, impacted these timelines, especially from March 2020-March 2021. These longer than anticipated timelines have put subject recruitment goals at risk and also increased cost for the current study. These findings indicate that at least one year should be built into study timelines prior to subject recruitment. This information should be helpful to other investigators planning multi-site investigator-initiated pediatric trials. Future research should examine specific methods for decreasing these timelines, with an emphasis on those trials that involve medically complex children.