Evidence map›Paper›PMID 37872545›Full record

ArticleBMC medicine2023

A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies.

Natansh D Modi, Ganessan Kichenadasse, Tammy C Hoffmann, Mark Haseloff, Jessica M Logan, Areti A Veroniki, Rebecca L Venchiarutti, Amelia K Smit, Haitham Tuffaha, Harindra Jayasekara and 6 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2023. 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
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  11. Human-based complexFrontiers in cell and developmental biology · 2025
    Review
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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

16 authors.

Natansh D ModiCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Ganessan KichenadasseCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Tammy C HoffmannInstitute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia.
Mark Haseloff, Adelaide, Australia.
Jessica M LoganClinical and Health Sciences, University of South Australia, Adelaide, SA, Australia.
Areti A VeronikiInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
Rebecca L VenchiaruttiSydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia.
Amelia K SmitThe Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council NSW, Sydney, NSW, Australia.
Haitham TuffahaCentre for the Business and Economics of Health, The University of Queensland, Brisbane, QLD, Australia.
Harindra JayasekaraCancer Epidemiology Division, Cancer Council Victoria, Melbourne, VIC, Australia.
Arkady Manning-BennetCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Erin MortonCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Ross A McKinnonCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Andrew RowlandCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Michael J SorichCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Ashley M HopkinsCollege of Medicine and Public Health, Flinders University, Adelaide, SA, Australia. ashley.hopkins@flinders.edu.au.ORCID http://orcid.org/0000-0001-7652-4378

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Data sharing is essential for promoting scientific discoveries and informed decision-making in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote scientific advancements. However, despite these commitments, recent investigations indicate significant scope for improvements in data sharing by the pharmaceutical industry. Drawing on a decade of literature and policy developments, this article presents perspectives from a multidisciplinary team of researchers, clinicians, and consumers. The focus is on policy and process updates to the PhRMA/EFPIA 2013 data sharing commitments, aiming to enhance the sharing and accessibility of participant-level data, clinical study reports, protocols, statistical analysis plans, lay summaries, and result publications from pharmaceutical industry-sponsored trials. The proposed updates provide clear recommendations regarding which data should be shared, when it should be shared, and under what conditions. The suggested improvements aim to develop a data sharing ecosystem that supports science and patient-centred care. Good data sharing principles require resources, time, and commitment. Notwithstanding these challenges, enhancing data sharing is necessary for efficient resource utilization, increased scientific collaboration, and better decision-making for patients and healthcare professionals.

Indexed as

Clinical Trials as TopicInformation DisseminationDrug IndustryHumansPolicyData sharingPharmaceutical industryPhRMA/EFPIATransparency

Identifiers

PMID37872545
PMCPMC10594907

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.