Table 2 Developing an author-completed checklist for journal articles reporting industry trials
From: Marketing trials, marketing tricks — how to spot them and how to stop them
Items for inclusion in checklist |
A. Commercial aspects of the study • Identification of all stakeholders, including manufacturer, agencies, academic institutions, authors, contributors • Who instigated the research? • How was it financed? Total, majority or minority finance from manufacturer? • Identify main product of commercial interest • Frank statement of the commercial relevance of the research (e.g. securing approval, demonstrating advantage over competitor, providing practical experience of product) • Details of intellectual property/data ownership and summary of data sharing plan • Details of all recent payments by manufacturer to participating institutions, agencies, authors and contributors • Confirmation that all author/contributor interests are registered on a public website • Public URL for all commercial publications plans in which the article is listed • Consent for journal to publish number of reprint/eprint sales for article B. Study design, analysis, interpretation and reporting • Clear characterization of company and agency role • Confirmation of compliance with reporting guidelines (CONSORT guidelines should be upgraded) • Provide point-by-point response to checklist of design features, identifying those potentially favouring the product or limiting the applicability of the study. Examples: Patient selection; Choice of control treatment; Doses and regimens; Run-in period; Assessment criteria; Safety definitions; Cut-off points for data inclusion; Deviations from protocol; Early stopping; etc. |
Responsibilities for journals |
• Ensure full checklists are provided with submission, signed off by the corresponding author and company representative • Ensure peer reviewers are provided with completed checklist • Use checklist to: ° Ensure potential methodological biases and design features likely to favour the product or limit the study’s applicability are fully described and prominently tabulated in the published article ° Check commercial roles and goals are prominently described in the article ° Check attribution, labelling and disclosures reflect true role of the company, e.g. name manufacturer in title of article; place article in designated “industry trials” section of journal • Publish completed checklists online for published articles • Publish reprint purchase numbers for all articles • Consider corrections, retraction, referral to research integrity office and legal action if checklist proves to have been inaccurately completed |