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Cited by 452Meta-analysis and systematic reviewsPharmaceutical industry and healthcareStatistical Methods in Clinical Trials

The DOI matches its Crossref record; 223 of the 223 references it cites were found in a registry or an index.

Reporting bias in medical research - a narrative review

Open access
McGauran, Natalie, Wieseler, Beate, Kreis, Julia, Schüler, Yvonne-Beatrice, Kölsch, Heike, Kaiser, Thomas·2010·Trials
DOI 10.1186/1745-6215-11-37PMC PMC2867979
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Abstract

Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors. The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting. We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is. For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles.We identified reporting bias in 40 indications comprising around 50 different pharmacological, surgical (e.g. vacuum-assisted closure therapy), diagnostic (e.g. ultrasound), and preventive (e.g. cancer vaccines) interventions. Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions: depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma. Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication. The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions.In conclusion, reporting bias is a widespread phenomenon in the medical literature. Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale. This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.

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Research works printed but not linked: 17

  1. National Institute for Health and Clinical Excellence: Guide to the methods of technology appraisal. London. 2008
  2. Moore TJ: Deadly medicine: why tens of thousands of heart patients died in America's worst drug disaster. 1995, New York: Simon & Schuster
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  4. Vedantam S: A silenced drug study creates an uproar. Washington Post. 2009, A01-
  5. Lurie P, Zieve A: Sometimes the silence can be like the thunder: access to pharmaceutical data at the FDA. Law Contemp Probl. 2008, 69: 85-97.
  6. King RT: Bitter pill: how a drug firm paid for university study, then undermined it. Wall Street Journal. 1996, 1: A13-
  7. Hilts PJ: Philip Morris blocked paper showing addiction, panel finds. New York Times. 1994, A7-
  8. Hilts PJ: Scientists say Philip Morris withheld nicotine findings. New York Times. 1994, A1-A7.
  9. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending regulation (EEC) no 1768/92, directive 2001/20/EC, directive 2001/83/EC and regulation (EC) No 726/2004. Official J Eur Commun. 2006, 49: L378/1-L378/19.
  10. Verband Forschender Arzneimittelhersteller: VFA-Positionspapier zum Thema "publication bias" [VFA position paper on the subject of "publication bias"]. 2008, Berlin: VFA
  11. Petersen M: Memos cast shadow on drug's promotion. New York Times. 2002, C2-
  12. Waxman HA: The Marketing of Vioxx to Physicians (Memorandum to Democratic members of the Government Reform Committee). 2005
  13. West RR, Jones DA: Publication bias in statistical overview of trials: example of psychological rehabilitation following myocardial infarction [Abstract]. Proceedings of the 2nd International Conference on the Scientific Basis of Health Services and 5th Annual Cochrane Colloquium; 1997 Oct 8-12; Amsterdam. Amsterdam. 1999, 17-
  14. Lenzer J: Drug secrets: what the FDA isn't telling. Slate Magazine. 2005, http://www.slate.com/id/2126918
  15. Berenson A: Data about Zetia risks was not fully revealed. New York Times. 2007
  16. Harris G: Approval of antibiotic worried safety officials. New York Times. 2006
  17. Blumsohn A: Authorship, ghostscience, access to data and control of the pharmaceutical scientific literature: who stands behind the word?. Prof Ethics Rep. 2006, 19: 1-4.

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Metadata

Authors
McGauran, N., Wieseler, B., Kreis, J., Schüler, Y.-B., Kölsch, H., & Kaiser, T.
Affiliations
Institute for Quality and Efficiency in Health Care (DE)
Corresponding author
McGauran, Natalie
ORCID
Venue
Trials
Publisher
Springer Science and Business Media LLC
Published
2010-04-13
Volume
11
Issue
1
Pages
37-37
ISSN
1745-6215 (ISSN-L)
DOI
10.1186/1745-6215-11-37
PMC
PMC2867979
OpenAlex
W2130998313
Cited by
452
References
223
Citations by year
2026: 13 · 2025: 18 · 2024: 15 · 2023: 29 · 2022: 23 · 2021: 31 · 2020: 40 · 2019: 28 · 2018: 38 · 2017: 26 · 2016: 26 · 2015: 33 · 2014: 24 · 2013: 35 · 2012: 35
FWCI
9.37
Type
journal article
Language
en
Open access
Licence
Locations
  • Trials (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
reporting bias, publication bias, selective outcome reporting
MeSH terms
Animals, Consumer Product Safety, Humans, Periodicals as Topic, Registries, Truth Disclosure, Reproducibility of Results, Treatment Outcome, Publication Bias, Evidence-Based Medicine, Databases as Topic, Access to Information, Biomedical Research

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