Pediatric antibacterial drug trials currently account for less than one percent of all interventional and observational pediatric studies registered on ClinicalTrials.gov between October 2007 and September 2015, or only 82 out of 12,703.
According to a series of surveys conducted by the Clinical Trials Transformation Initiative, three of the four major barriers identified by respondents were related to parental involvement and consent.
They included obtaining consent when there is evident disagreement between two parents, parental concerns about the number of blood draws and invasive procedures required by the study protocol. Many parents are reluctant to give consent when they see no direct benefit for their child in a clinical trial and are happy with current care, one respondent said.
Interviews with parents found that each aspect of a study, from initial explanations to reporting the final result, can affect willingness to provide consent. Establishing trust and empathy, as well as providing clear transparency on any risks and benefits, were key decisionmaking factors, CTTI said, describing how parents’ priorities must be incorporated early into trial design for accrual to be successful.
All survey participants strongly preferred to hear about a clinical trial opportunity first from their child’s own pediatrician or from a doctor caring for them in the hospital — rather than being cold-called by a researcher or a stranger. In addition, being approached too soon or too often can be a detriment, such as during the first few days after birth, in the case of premature newborns in neonatal intensive care.
The remaining barrier related to overly narrow inclusion and exclusion recruitment criteria, including prerequisites disallowing the use of other antibacterial drugs prior to enrollment.
Additionally, finding study coordinators with sufficient experience was a significant challenge, with one respondent recommending long-term staff support to help avoid constantly training new staff for each trial.
CTTI’s study identified several recommendations to help facilitate more studies. For example, pediatric trial networks can facilitate development and eliminate the need for startup with each new trial, as well as help standardize site resources and funding.
Another main factor was the ability to recruit study participants directly from the investigators’ own practice, the surveys found. Having dedicated staff available to enroll patients in inpatient studies with little advance warning, potentially 24 hours a day, was described as a major benefit.
Established referral systems, interdisciplinary collaborations and access to the hospital inpatient database were all listed as crucial for recruitment, and supporting the buy-in of other practitioners for their pediatric patients to enroll.
