Funding (Sponsorship) bias

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Funding (Sponsorship) bias

What is this about?

When researchers distort the results or modify conclusions of their study due to pressure of commercial or not-for-profit funders of the study, they engage in questionable research practice. This is called funding or sponsorship bias, but it is also known as “funding effect.”

Why is this important?

The term “funding effect” was formed in the 1980s, when it was discovered that researchers do not always report their results and conclusions honestly, but distort the findings to support the aims of the funding sources.[1]  It has also shown that industry sponsored studies are more likely to publish positive results than those sponsored by not-for-profit and independent organisations.[1] One of the reasons is that funders may prevent publishing of the manuscript containing unfavourable results or even take some legal acts against researchers.[2] For example, in one case a sponsor sued a haematologist for breach of contract because she reported “concerns over the safety of a drug she was evaluating”.[3]

This distortion of reporting of the study results and conclusions occurs more often in studies funded by the pharmaceutical industry.[1] This can cause serious consequences because it directly affects the practice of medicine.[4] Nevertheless, every researcher with a funded study could be pressured to report results and conclusions that are more favourable to the funders, regardless of the topic or research area of the study.

  1. 1.0 1.1 1.2 Krimsky S. Do Financial Conflicts of Interest Bias Research? An Inquiry into the “Funding Effect” Hypothesis. ST&HV. 2012; 38(4):566-587.
  2. Rodrigues V. Publication and reporting biases and how they impact publication of research. editage insights. 2013 Oct 29. [cited 2021 Sept 27]. Available from: https://www.editage.com/insights/publication-and-reporting-biases-and-how-they-impact-publication-of-research.
  3. Chopra SS. Industry Funding of Clinica Trials: Benefit or Bias? JAMA. 2003;290(1):113-114.
  4. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326(7400):1167-1170.

For whom is this important?

What are the best practices?

To prevent funding bias, the International Committee of Medical Journal Editors (ICMJE) requires that research articles have Disclosure Form containing:

“-sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design;

-collecting, analysis, and interpretation of data;

-writing of the report;

-any restrictions regarding submission of the report for publication;

-or a statement declaring that the supporting source had no such involvement or restrictions regarding publication.”[1]

In addition to that, editors may request that authors also sign a statement, such as: “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis”.[1]

Some investigators have even proposed that academic studies funded by industry should continue only if academic medical centres would be solely responsible for the design, conduct, analysis, and reporting of clinical trials. Others have recommended that conflict-of-interest committees should be created at academic institutions to monitor the finances.[2]

  1. 1.0 1.1 Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated December 2019. [cited 2021 Sept 27]. Available from: http://www.icmje.org/icmje-recommendations.pdf.
  2. Chopra SS. Industry Funding of Clinica Trials: Benefit or Bias? JAMA. 2003;290(1):113-114.

In Detail

The main method for assessing the efficacy and safety of novel medications and other medical technology is clinical trials. The results of these research, when published in peer-reviewed publications, not only large medical community a scientific foundation for making treatment decisions, but also fund further research. However, pharmaceutical firms with large financial interests in the items being tested finance the majority of clinical trials. Additionally, they frequently pay the scientists who plan, carry out, evaluate, and report clinical trials in the form of wages or consultancy fees. This raises important questions like, should those who have a financial interest in clinical trial results be so invested in its execution? What potential sources of bias may the industry funding of these research have? How are reliable and impartial trial report data ensured by medical journals? Also, it brings a certain stigma and mistrust from the general public.

When searching the literature notes and guidelines can be found on proper steps when publishing a research with funding from external sources. All research articles should have a funding acknowledgement statement included in the manuscript in the form of a sentence under a separate heading entitled ‘Funding’ directly after your Acknowledgements and Declaration of Conflicting Interests, if applicable, and prior to any Notes and your References. The funding agency should be written out in full, followed by the grant number in square brackets, see following example (the text in bold is mandatory, unless specified otherwise by the journal).

A comma and space should be used to separate multiple grant numbers. When more than one agency contributed to funding a study, a semicolon should be used to separate each agency, and the word "and" should come before the last funder.

Industry-funded studies will only be taken into consideration by SAGE publications if sponsorship is explicitly disclosed in the manuscript (where applicable). The funding source's involvement in the study's design, data analysis, and interpretation must also be disclosed by the authors.

According to some researchers, to assure impartiality in clinical research industry-academia partnerships should only continue if academic medical centers take full ownership of the planning, execution, analysis, and reporting of clinical trials. There is an idea of setting up conflict-of-interest committees at academic institutions to maintain a close eye on the financial motivations of both clinician-investigators and institutional decision-makers. Such approaches may aid in reducing the possibility of bias in industry-sponsored research by introducing checks and balances for academic-industry collaborations.

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