Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Abstract

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation.Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions.In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Feasibility of parent communication training with remote coaching using smartphone apps

“…, Greenberg et al . ). Measures of parent characteristics, such as familiarity with technology, education and employment, may also help to identify the families for which the intervention is most suitable.…”

“…Nevertheless, although recruitment via healthcare professionals may offer parents an opportunity to be open about why they opting out, it also opens the risk of gate-keeping and consequent under-recruitment (Sharkey et al 2010, Tromp andVathorst 2015). Future researchers should design methods of recruitment with parent and multidisciplinary team representatives that can provide balanced information about research to all families who fit the criteria from trustworthy sources and capture reasons for opting out , Greenberg et al 2018. Measures of parent characteristics, such as familiarity with technology, education and employment, may also help to identify the families for which the intervention is most suitable.…”

Systems Biology Approach Identifies Prognostic Signatures of Poor Overall Survival and Guides the Prioritization of Novel BET-CHK1 Combination Therapy for Osteosarcoma

“…Therefore, to increase the consistency of tumor take and growth kinetics, a two-step approach was utilized. Saos2 CDX were first established in female NSG (6)(7)(8) week old mice) by the implantation of 5 × 10 6 Saos2 cells (200 µL 1:1 Matrigel to basal RPMI). We found that matching the gender of the tumor sample with the gender of the NSG mice (6-8 weeks old) used for tumor implant improves tumor take and allows for more consistent tumor growth kinetics.…”

“…Additionally, in the last 3-4 decades, early phase clinical trials have failed to show promise for the treatment of not only primary OS, but also the more aggressive (relapsed/refractory) form of the disease [6]. The rarity of this disease and small patient populations continue to pose a challenge for initiating new clinical trials for pediatric and AYA OS patients [7]. Therefore, it is critical to understand the molecular heterogeneity and identify biomarkers within the complex genetic landscape of OS, so that actionable targets can ultimately be tested in clinical trials [3].…”

Can they stomach it? Parent and practitioner acceptability of a trial comparing Gastric Residual Volume measurement versus no Gastric Residual Volume in UK NNU and PICU’s

“…Clinical trials in the neonatal and paediatric critical care setting are challenging to conduct due to ethical and practical considerations [19][20][21][22]. In line with the Medical Research Council's framework for complex intervention development [23] conducting trial feasibility studies can help mitigate these challenges and establish whether the trial is acceptable to parents and practitioners, and practical to conduct [24,25].…”