DESIGN AND REPORTING MODIFICATIONS IN INDUSTRY-SPONSORED COMPARATIVE PSYCHOPHARMACOLOGY TRIALS
Abstract
This review of recently published pharmaceutical industry-sponsored comparative psychotropic drug trials aims to classify apparent design and reporting modifications that favor the sponsor's product. The modifications have been grouped into 13 discrete categories, and representative examples of each are presented. Strong circumstantial evidence suggests that marketing goals led to these adjustments. The consequences of marketing influences on comparative psychopharmacology trials are discussed in terms of conflicts of interest, the integrity of the scientific literature, and costs to consumers, as well as their impact on physician practice.
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Authors or funders may have conflicts of interest that influence the design of the study, choice of exposures, outcomes, statistical methods, and selective publication of outcomes and studies.
“Authors or funders may have conflicts of interest that influence any of the following: the design of the study [ 228 ]; choice of exposures [ 228 , 229 ], outcomes [ 230 ], statistical methods [ 231 ], and selective publication of outcomes [ 230 ] and studies [ 232 ].”
From Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration (2007) · cites this paper as [228]
Cites
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“Some researchers use unpublished rating scales, and as a group, these are said to constitute “a major source of bias in randomized controlled clinical trials” (Marshall et al., 2000).”
BackgroundUneasy alliance—clinical investigators and the pharmaceutical industry
Bodenheimer, T. (2000) · New England Journal of Medicine · doi:10.1056/nejm200005183422024 · Cited by 765 · cited 1× · see citing works
“Although legal restraints have curtailed some excessive industry financial incentives to physicians, the financial power of the big pharmaceutical companies continues to make them far and away the dominant vendors of clinical research (Bodenheimer, 2000; Silversides, 1998).”
BackgroundMontejo-gonzàlez, A. L., Llorca, G., Izquierdo, J. A., Ledesma, A., Bousono, M., Calcedo, A., Carrasco, J. L., Ciudad, J., Daniel, E., De LA Gandara, J., et al. (1997) · Journal of Sex & Marital Therapy · doi:10.1080/00926239708403923 · Cited by 505 · see citing works
Source of funding and outcome of clinical trials
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“4 to 8 (Rudolph and Feiger, 1999), and to an average of 40 mg/day in 10 of the 21 subjects at 4 weeks”
BackgroundHotopf, M., Lewis, G., & Normand, C. (1997) · Journal of Epidemiology and Community Health · doi:10.1136/jech.51.4.354 · Cited by 130 · see citing works
Flagged first, then by citations
Cited by
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Vandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., Egger, M., & Initiative, F. T. S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040297 · Cited by 8,613 · see citing works
“Authors or funders may have conflicts of interest that influence any of the following: the design of the study [228]; choice of exposures [228,229], outcomes [230], statistical methods [231], and selective publication of outcomes [230] and studies [232].”
Vandenbroucke, J. P., Elm, E. V., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., Egger, M., & initiative, F. T. S. (2007) · Annals of Internal Medicine · doi:10.7326/0003-4819-147-8-200710160-00010-w1 · Cited by 3,543 · see citing works
Vandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., & Egger, M. (2014) · International Journal of Surgery · doi:10.1016/j.ijsu.2014.07.014 · Cited by 2,969 · see citing works
Vandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., & Egger, M. (2007) · Epidemiology · doi:10.1097/ede.0b013e3181577511 · Cited by 2,779 · see citing works
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Lexchin, J., Bero, L. A., Djulbegovic, B., & Clark, O. (2003) · BMJ · doi:10.1136/bmj.326.7400.1167 · Cited by 2,147 · see citing works
Industry sponsorship and research outcome
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Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov
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Considering bias and conflicts of interest among the included studies
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Industry sponsorship and research outcome: systematic review with meta-analysis
Lundh, A., Lexchin, J., Mintzes, B., Schroll, J. B., & Bero, L. (2018) · Intensive Care Medicine · doi:10.1007/s00134-018-5293-7 · Cited by 162 · see citing works
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Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events
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- Authors
- SAFER, D. J.
- Affiliations
- Johns Hopkins University (US)
- Corresponding author
- SAFER, DANIEL J.
- ORCID
- SAFER, DANIEL J.
- Venue
- The Journal of Nervous and Mental Disease
- Published
- 2002-09
- Volume
- 190
- Issue
- 9
- Pages
- 583-592
- ISSN
- 0022-3018 (ISSN-L)
- OpenAlex
- W2036496488
- Cited by
- 180
- References
- 7
- Citations by year
- 2026: 1 · 2025: 15 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 2 · 2019: 8 · 2018: 4 · 2017: 4 · 2016: 4 · 2015: 6 · 2014: 4 · 2013: 7 · 2012: 4
- FWCI
- 1.26
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Nervous and Mental Disease (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Keywords
- industry-sponsored trials, pharmaceutical marketing, conflicts of interest, reporting bias, scientific integrity, drug costs, physician practice, pharmaceutical industry influence
- MeSH terms
- Mental Disorders, Clinical Protocols, Clinical Trials as Topic, Confidentiality, Drug Administration Schedule, Drug Industry, Fraud, Humans, Periodicals as Topic, Practice Patterns, Physicians', Psychopharmacology, Psychotropic Drugs, Research Design, Research Support as Topic, Duplicate Publications as Topic, Drug Costs, Treatment Outcome, Publication Bias, Patient Selection
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