Evidence map›Paper›PMID 34281933›Full record

ArticleBMJ open2021

Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis.

Sydney Axson, Michelle M Mello, Deborah Lincow, Catherine Yang, Cary Gross, Joseph S Ross, Jennifer Miller

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
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

6 citing papers in PubMed, 15 citations in OpenAlex.

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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

7 authors at 3 institutions in 1 country.

Sydney AxsonInternal Medicine, Yale University School of Medicine, New Haven, CT, USA.ORCID 0000-0001-7308-0871
Michelle M MelloCenter for Health Policy/Primary Care and Outcomes Research, Department of Medicine, Stanford University School of Medicine; Stanford University Law School, Stanford, CA, USA.
Deborah LincowDepartment of Genetics, Yale University School of Medicine, New Haven, CT, USA.
Catherine YangUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Cary GrossDepartment of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
Joseph S RossDepartment of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
Jennifer MillerDepartment of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA jennifer.e.miller@yale.edu.
Yale University · USStanford Health Care · USUniversity of Pennsylvania · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
Understanding hospital value: provider, hospital and community effectsR01HS022882 · AHRQ · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI HORWITZ, LEORA · 2014 to 2023
$2.9M
Leveraging Physician Networks to Improve Care and Outcomes for Low-Income PopulationsR01HL144644 · NHLBI · YALE UNIVERSITY · PI NDUMELE, CHIMA · 2019 to 2021
$1.6M
Medical reversals: De-implementing ineffective and unsafe treatmentsR01HS025164 · AHRQ · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2017 to 2020
$1.4M
AHRQ HHS R01 HS022882AHRQ HHS R01 HS025164FDA HHS U01 FD005938NCATS NIH HHS UL1 TR001863NHLBI NIH HHS R01 HL144644
6 · The paper itself

Abstract

objectivesTo examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.

designCross-sectional descriptive analysis. SETTING AND

participantsNovel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.

main outcome measuresUsing established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.

results26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91-100) vs 59% (IQR 41-70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88-100) vs 57% (0-100), p=0.01) and better data sharing (median of 100% (IQR 80-100) vs 20% (IQR 20-40), p<0.01). No significant differences were observed by company location or product type.

conclusionsIt was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements. Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.

Indexed as

Biological ProductsInformation DisseminationCross-Sectional StudiesDrug ApprovalHumansUnited StatesUnited States Food and Drug AdministrationBiological Productsclinical trialsethics (see medical ethics)health policy

Identifiers

PMID34281933
PMCPMC8291313
OpenAlexW3184431028

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.