Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jan 18;7(1):8.
doi: 10.1186/s13643-018-0675-z.

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  1 , Peter C Gøtzsche  2 , Tom Jefferson  2
Affiliations

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 et al. Syst Rev. .

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.

Keywords: Clinical study reports; Human papillomavirus vaccine; Index; Reporting bias; Study programme.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

LJ and PCG have no conflicts of interest to declare. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011–14, TJ acted as an expert witness in a litigation case related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997–99), GlaxoSmithKline (2001–2), Sanofi-Synthelabo (2003) and IMS Health (2013). In 2014–16, TJ was a member of three advisory boards for Boehringer Ingelheim and is holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. TJ was a co-signatory of the Nordic Cochrane Centre’s complaint to EMA over maladministration at EMA in relation to the investigation of alleged harms of HPV vaccines and consequent complaints to the European Ombudsman. TJ is also sole author of a complaint to the European Ombudsman over slowness and redactions of clinical study reports of HPV vaccine released by EMA.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of the identification of the HPV vaccines industry study programmes and non-industry funded clinical studies
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. McGauran N, Wieseler B, Kreis J, Schüler Y-B, Kölsch H, Kaiser T. Reporting bias in medical research - a narrative review. Trials. 2010;11:37. doi: 10.1186/1745-6215-11-37. - DOI - PMC - PubMed
    1. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.Gov: cross sectional analysis. BMJ. 2012;344:d7292. doi: 10.1136/bmj.d7292. - DOI - PMC - PubMed
    1. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290(7):921–928. doi: 10.1001/jama.290.7.921. - DOI - PubMed
    1. Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, Kaiser T, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737. doi: 10.1136/bmj.c4737. - DOI - PMC - PubMed
    1. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. In: Cochrane database of systematic reviews [internet]. John Wiley & Sons, Ltd; 2017 [cited 3 Apr 2017]. Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.MR000033.pub3/abstract - DOI - PMC - PubMed

Publication types

Substances

LinkOut - more resources