Evidence map›Paper›PMID 29696222›Full record

ArticleContemporary clinical trials communications2018

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

Rachel G Greenberg, Breck Gamel, Diane Bloom, John Bradley, Hasan S Jafri, Denise Hinton, Sumathi Nambiar, Chris Wheeler, Rosemary Tiernan, P Brian Smith and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Journal of child health care : for professionals working with children in the hospital and community · 2022
    Trial
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  11. Evaluation of an Interactive, Educational Website Developed for Adolescents to Learn About Pediatric Clinical Trials: DigiKnowIt News.Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners
    Trial
  12. Article
  13. Article
  14. Article
  15. Article
  16. Collaborative Efforts in Pediatric Surgery: Lessons from European Randomized Controlled Trials.European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie · 2025
    Review
  17. Article
  18. Article
  19. Article
  20. Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Rachel G GreenbergDuke Clinical Research Institute, 2400 Pratt Street, Durham, NC, 27705, USA.
Breck Gamel401 Sagewood Drive, Hewitt, TX, 76643, USA.
Diane BloomGillings School of Global Public Health, University of North Carolina-Chapel Hill, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.
John BradleyRady Children's Hospital, University of California San Diego, 3020 Children's Way, San Diego, CA, 92123, USA.
Hasan S JafriMedImmune, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
Denise HintonFood and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Sumathi NambiarFood and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Chris WheelerFood and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
Rosemary TiernanFood and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
P Brian SmithDuke Clinical Research Institute, 2400 Pratt Street, Durham, NC, 27705, USA.
Jamie RobertsClinical Trials Transformation Initiative, 300 W. Morgan Street, Suite 800, Durham, NC, 27701, USA.
Daniel K BenjaminDuke Clinical Research Institute, 2400 Pratt Street, Durham, NC, 27705, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

ABDDABDD, antibacterial drug developmentABDD Peds Trials, Clinical Trials Transformation Initiative ABDD Pediatric TrialsADHD, attention-deficit/hyperactivity disorderAntibacterialFDA, Food and Drug AdministrationHPV, human papillomavirusInterviewIRB, Institutional Review BoardMRI, magnetic resonance imagingNICHD, National Institute for Child Health and Human DevelopmentNIH, National Institutes of HealthParental consentPediatric clinical trialsRecruitment

Identifiers

PMID29696222
PMCPMC5898566

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.