Evidence map›Paper›PMID 36479465›Full record

ReviewOrthopaedic journal of sports medicine2022

Regulatory and Ethical Aspects of Orthobiologic Therapies.

Iain R Murray, Jorge Chahla, Sarah J Wordie, Shane A Shapiro, Nicolas S Piuzzi, Rachel M Frank, Joanne Halbrecht, Kiyoshi Okada, Norimasa Nakamura, Bert Mandelbaum and 27 more

Abstract readReview
In one paragraph

Review in Orthopaedic journal of sports medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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

18 citing papers in PubMed.

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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

37 authors.

Iain R Murray
Jorge Chahla
Sarah J Wordie
Shane A Shapiro
Nicolas S Piuzzi
Rachel M Frank
Joanne Halbrecht
Kiyoshi Okada
Norimasa Nakamura
Bert Mandelbaum
Jason L Dragoo
Biologics Association
Joanne Borg-Stein
Adam Anz
Alberto Gobbi
Andreas H Gomoll
Brian J Cole
Christian Lattermann
Constance Chu
Daniel A Grande
Daniel B F Saris
David Flanigan
Elizaveta Kon
George F Muschler
Gerard A Malanga
Greg Dummer
Jack Farr
John M Tokish
Kurt P Spindler
Kay Horsch
Ken Zaslav
Louis F McIntyre
Nicholas A Sgaglione
Seth L Sherman
Scott Rodeo
Tariq M Awan
C Thomas Vangsness

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.

Indexed as

biologicsorthobiologicsoversightregenerationregulation

Identifiers

PMID36479465
PMCPMC9720812

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.