Evidence map›Paper›PMID 30409192›Full record

ReviewStem cell research & therapy2018

Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials.

Erika Kleiderman, Audrey Boily, Craig Hasilo, Bartha Maria Knoppers

Abstract readReview
In one paragraph

Review in Stem cell research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

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

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

  1. Pooled it
  2. Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Pooled it
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  11. Advanced therapy medicinal products: value judgement and ethical evaluation in health technology assessment.The European journal of health economics : HEPAC : health economics in prevention and care · 2020
    Article
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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

4 authors.

Erika KleidermanCentre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, QC, H3A 0G1, Canada. erika.kleiderman@mcgill.ca.ORCID 0000-0002-0242-2296
Audrey BoilyCentre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, QC, H3A 0G1, Canada.
Craig HasiloCellCAN, Pavillon Rachel-Tourigny RT2101, Montreal, QC, H1T 2M4, Canada.
Bartha Maria KnoppersCentre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, QC, H3A 0G1, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the context of regenerative medicine and cellular therapies, the treatment under study often targets a less common disease or condition for which recruitment of a large number of research participants at any given site is challenging, if not impossible. One way to overcome this challenge is with a multi-centre clinical trial. This manuscript first aims to briefly outline the existing ethical, legal and social implications as well as the regulatory frameworks associated with multi-centre regenerative medicine clinical trials. Second, it considers the regulatory limitations and barriers surrounding the initiation of such trials in Canada, the USA and Europe. Third, it concludes with a set of recommendations for facilitating multi-centre clinical trials, at both national and international levels.

Indexed as

Clinical Trials as TopicMulticenter Studies as TopicRegenerative MedicineSocial Control, FormalHumansCell therapyEthicsMulti-centre clinical trialPolicyRegenerative medicineRegulation

Identifiers

PMID30409192
PMCPMC6225696

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.