Evidence map›Paper›PMID 29347995›Full record

ArticleSystematic reviews2018

Index of the human papillomavirus (HPV) vaccine industry clinical study programmes and non-industry funded studies: a necessary basis to address reporting bias in a systematic review.

Lars Jørgensen, Peter C Gøtzsche, Tom Jefferson

Open access · goldAbstract read
In one paragraph

Article in Systematic reviews, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 5 pooled it
4.9field-weighted citation impact, top 5% 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

10 citing papers in PubMed, 5 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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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

3 authors at 1 institution in 1 country.

Lars JørgensenNordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark. lj@cochrane.dk.ORCID 0000-0002-9737-0555
Peter C GøtzscheNordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Tom JeffersonNordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Rigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUnabridged access to drug industry and regulatory trial registers and data reduces reporting bias in systematic reviews and may provide a complete index of a drug's clinical study programme. Currently, there is no public index of the human papillomavirus (HPV) vaccine industry study programmes or a public index of non-industry funded studies.

methodsBy cross-verification via study programme enquiries to the HPV vaccine manufacturers and regulators and searches of trial registers and journal publication databases, we indexed clinical HPV vaccine studies as a basis to address reporting bias in a systematic review of clinical study reports.

resultsWe indexed 206 clinical studies: 145 industry and 61 non-industry funded studies. One of the four HPV vaccine manufacturers (GlaxoSmithKline) provided information on its study programme. Most studies were cross-verified from two or more sources (160/206, 78%) and listed on regulatory or industry trial registers or journal publication databases (195/206, 95%)-in particular, on ClinicalTrials.gov (176/195, 90%). However, study results were only posted for about half of the completed studies on ClinicalTrials.gov (71/147, 48%). Two thirds of the industry studies had a study programme ID, manufacturer specific ID, and national clinical trial (NCT) ID (91/145, 63%). Journal publications were available in journal publication databases (the Cochrane Collaboration's Central Register of Controlled Trials, Google Scholar and PubMed) for two thirds of the completed studies (92/149, 62%).

conclusionWe believe we came close to indexing complete HPV vaccine study programmes, but only one of the four manufacturers provided information for our index and a fifth of the index could not be cross-verified. However, we indexed larger study programmes than those listed by major regulators (i.e., the EMA and FDA that based their HPV vaccine approvals on only half of the available trials). To reduce reporting bias in systematic reviews, we advocate the registration and publication of all studies and data in the public domain.

Indexed as

Abstracting and IndexingAccess to InformationBiasBiomedical ResearchPapillomavirus VaccinesClinical Trials as TopicDatabases, PharmaceuticalHumansPublishingSystematic Reviews as TopicPapillomavirus VaccinesClinical study reportsHuman papillomavirus vaccineIndexReporting biasStudy programme

Identifiers

PMID29347995
PMCPMC5774129
OpenAlexW2790251258

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.