Evidence map›Paper›PMID 31253625›Full record

ArticleBMJ open2019

Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada.

Lauren E Kelly, Lawrence Richer, Samina Ali, Amy C Plint, Naveen Poonai, Stephen B Freedman, Lisa Knisley, Carolyn Shimmin, Serena Hickes, Geert W 't Jong and 4 more

Abstract readMulticenter Study
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
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

14 authors.

Lauren E KellyPediatrics and Child Health, University of Manitoba, College of Medicine, Winnipeg, Manitoba, Canada.ORCID 0000-0001-7567-0816
Lawrence RicherPaediatrics, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-6897-8668
Samina AliPaediatrics and Emergency Medicine, Edmonton Clinic Health Academy, University of Alberta, Edmonton, Alberta, Canada.ORCID 0000-0002-0595-364X
Amy C PlintChildren's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
Naveen PoonaiPaediatrics and Internal Medicine, Schulich School of Medicine & Dentistry, London Health Sciences Centre, London, Ontario, Canada.
Stephen B FreedmanPaediatrics, Alberta Children's Hospital, Calgary, Alberta, Canada.
Lisa KnisleyChildren's Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada.
Carolyn ShimminPatient Engagement Lead, Knowledge Translation Platform, George and Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.
Serena HickesParent Partner, University of Manitoba Children's Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada.
Geert W 't JongPediatrics and Child Health, University of Manitoba, College of Medicine, Winnipeg, Manitoba, Canada.
Petros PechlivanoglouPeter Gilgan Centre for Research and Learning, Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.
Martin OffringaPeter Gilgan Centre for Research and Learning, Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Ontario, Canada.
Thierry LacazePediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
Terry P KlassenPediatrics and Child Health, University of Manitoba, College of Medicine, Winnipeg, Manitoba, Canada.

Funding

CIHR MR/S003118/1
6 · The paper itself

Abstract

Data from clinical trials are needed to guide the safe and effective use of medicines in children. Clinical trials are challenging to design and implement in all populations, and children present additional considerations. Several regions including the UK, USA and Europe have established clinical trial infrastructure to capitalise on expertise and promote clinical trials enrolling children. Our objective is to describe the partnerships and operational considerations for the development of paediatric clinical trials infrastructure in Canada. We describe the design and conduct of four emergency room paediatric trials, with four separate sponsors, across four provinces in parallel. Operations discussed include multisite contract development, centralised risk-based data monitoring, ethical review and patient engagement. We conclude with lessons learnt, additional challenges and potential solutions to facilitate drug development for children in Canada.

Indexed as

Clinical Trials as TopicDrug DevelopmentPediatricsCanadaClinical Trials Data Monitoring CommitteesEthics, ResearchHumansPatient ParticipationRisk Managementclinical trialsethics (see medical ethics)paediatrics

Identifiers

PMID31253625
PMCPMC6609139

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.