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Human Research Ethics Research Integrity

Sponsorship bias in clinical trials: growing menace or dawning realisation? (Papers: Tom Jefferson | April 2020)

Posted by Dr Gary Allen in Human Research Ethics on September 11, 2020
Keywords: Clinical trial, Human research ethics, Journal, Medical research, Merit and integrity, Publication ethics, Research results, Researcher responsibilities

The Linked Original Item was Posted On April, 18 2020

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Introduction
If therapeutic decisions in healthcare are to be informed by the results of clinical research, patients and prescribers must be able to trust the research evidence presented to them. In recent decades, the credibility of much of the evidence base for some of the most popular therapeutic and preventive interventions has been undermined by the identification of sponsorship bias.

The combination of sponsored trial bias and unreported results are a major concern for patient safety and clinical practice, as well as for the integrity of clinical trials.

Sponsorship bias is the distortion of design and reporting of clinical experiments to favour the sponsor’s aims. By using the word ‘sponsor’, I am not implying here that the origins of bias are solely or principally commercial. Sponsors are the funders and stakeholders active within the design, setting-up, running and reporting of clinical trials, including the members of research teams.

Until recently, the distortions introduced by sponsorship bias were recognised as important but difficult to identify with certainty because of the secrecy surrounding pharmaceutical trials. Recent developments, such as relaxation of access to regulatory material,1 have led to relatively successful efforts to identify and describe sponsorship bias.

The problem of sponsorship bias was recognised a century ago. In 1917, Torald Sollmann warned of the effects of secrecy and closeness between those who manufacture drugs, those who test them and those who publicise them. As a member of the Council on Pharmacy and Chemistry of the American Medical Association (forerunner of the U.S. Food and Drug Administration), Sollmann was able to identify ‘poor quality’ and secrecy (publication bias) as major threats to the credibility of the reports submitted to the Council.

Jefferson, T. (2019). Sponsorship bias in clinical trials – growing menace or dawning realisation? James Lind Library Bulletin: Commentaries on the history of treatment evaluation (https://www.jameslindlibrary.org/articles/sponsorship-bias-in-clinical-trials-growing-menace-or-dawning-realisation/)
Publisher (Open Access): https://www.jameslindlibrary.org/articles/sponsorship-bias-in-clinical-trials-growing-menace-or-dawning-realisation/

Related Reading

(US) Following court ruling, NIH warns drug and device companies to post missing trial data – STAT News (Lev Facher | August 2020)

Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis (Papers: Hemalkumar B Mehta, et al | June 2020)

Data show panic and disorganization dominate the study of Covid-19 drugs – STAT (Matthew Herper | July 2020)

(US) Senators ask government watchdog to investigate for-profit study review boards (June 2020)

Improving communication when seeking informed consent: a randomised controlled study of a computer‐based method for providing information to prospective clinical trial participants (Papers: Asuntha S Karunaratne, et al | 2010)

(US) Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data – STAT (Lev Facher | February 2020)

Clinical trials: how to make informed consent more ethical – The Conversation (Jeremy Howick | February 2020)

(US) FDA and NIH let clinical trial sponsors keep results secret and break the law – Science (Charles Piller | January 2020)

Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)

European universities dismal at reporting results of clinical trials – Nature (Nic Fleming | April 2019)

(US/UK) Data suggest US, UK universities fall woefully short on reporting clinical trial results – Endpoints News (Natalie Grover | March 2019)

Move clinical trial data sharing from an option to an imperative – STAT (Rebecca Li | February 2019)

Ask the patients about the benefits and the risks – The Ethics Blog (Pär Segerdah | January 2019)

(UK) Crackdown on unreported trials is good news for researchers – *Research (Till Bruckner | November 2018)

How a simple ‘thank you’ could improve clinical trials – Nature (Editorial | November 2018)

A Major Industry-Funded Alcohol Study Was Compromised. How Many Others Are Out There? – UnDark (Jeremy Samuel Faust | July 2018)

“A concerning – largely unrecognised – threat to patient safety:” Nursing reviews cite retracted trials – Retraction Watch (Alison McCook | January 2018)

‘Guinea pigs’: experimental implants done despite no approval for human use – The Guardian (Hannah Devlin | October 2017)

Academic claims ‘integrity’ of nurse studies often undermined by poor trial registration – Nursing Times (Jo Stephenson | August 2017)

In major shift, medical journal to publish protocols along with clinical trials – Retraction Watch (Alison McCook May 2016)

Is it worth becoming a human guinea pig? The risks and rewards of clinical trials – Radio National: Rear Vision (Annabelle Quince 2016)

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