Skip to main content
main-content

01.12.2018 | Research | Ausgabe 1/2018 Open Access

Systematic Reviews 1/2018

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

Zeitschrift:
Systematic Reviews > Ausgabe 1/2018
Autoren:
Lars Jørgensen, Peter C. Gøtzsche, Tom Jefferson
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13643-018-0675-z) contains supplementary material, which is available to authorized users.

Abstract

Background

Unabridged 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.

Methods

By 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.

Results

We 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%).

Conclusion

We 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.
Zusatzmaterial
Additional file 1: Index of the HPV vaccines clinical studies: Search strategy for identifying the HPV vaccines industry study programmes and non-industry funded clinical studies. (DOC 1294 kb)
13643_2018_675_MOESM1_ESM.doc
Additional file 2: Index of the HPV vaccines clinical studies: Correspondence with the HPV vaccine manufacturers for the assessment of the accuracy of our indexed industry study programmes. (DOC 151 kb)
13643_2018_675_MOESM2_ESM.doc
Additional file 3: Index of the HPV vaccines clinical studies: Indexes of the identified industry study programmes and non-industry funded clinical studies and a list of the identified corresponding journal publications. (DOC 659 kb)
13643_2018_675_MOESM3_ESM.doc
Additional file 4: Prisma 2009 checklist. (DOCX 147 kb)
13643_2018_675_MOESM4_ESM.docx
Additional file 5: Data sharing agreement with GlaxoSmithKline.(PDF 301 kb)
13643_2018_675_MOESM5_ESM.pdf
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2018

Systematic Reviews 1/2018 Zur Ausgabe