Explanation

Conflicts of interest (also known as competing interests) may be defined as a “a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest.”(109) In the context of a clinical trial, conflicts of interest imply a risk that investigators’ personal interests, or ties with companies or organisations, will unduly influence the design, conduct, analysis, or reporting of a trial. The concept implies a risk of influence and is not indicative of actual wrongdoing.

Disclosure of interests enables a management plan to be developed and implemented and facilitates full ascertainment of conflicts of interest, risk of bias, and overall methodological quality (e.g., relevance of the type of comparator intervention).

Types of financial ties include salary support or grants; ownership of stock or options; honoraria (e.g., for advice, authorship, or public speaking); paid consultancy or service on advisory boards and speakers’ bureaus; and holding of patents or patents pending. Non-financial conflicts of interest include academic commitments; personal or professional relationships; and political, religious, or other affiliations with special interests or advocacy positions.

A cross-sectional study of 190 randomised trials, published in core clinical journals, found that trials with stated authors’ conflicts of interest had more positive results than trials without. The presence of a financial tie was associated with a positive study outcome, odds ratio 3.23 (1.7 to 6.1). This association was also present after adjustment for the study funding source, odds ratio 3.57 (1.7 to 7.7).(110) Conflicts of interest are most often associated with drug and device industries, but they may exist with support from or affiliation with government agencies, charities (not-for-profit organisations), and professional and civic organisations,(107) though this has been much less investigated. Reviews of two samples of 108 and 292 trial protocols from 2016 found that 65% and 62% respectively reported declarations of interests.(9, 10)

The protocol should identify conflicts of interest of the principal investigators and members of main committees, e.g., the first author, the last author, and the corresponding author of the protocol, the trial statistician/epidemiologist, and the heads and members of the trial steering and data monitoring committees. The protocol should also describe procedures planned to reduce the risk that conflicts of interest could influence the trial’s design, conduct, analysis, or reporting.

Summary of key elements to address

● Conflicts of interests for principal trial investigators and members of key committees involved in the trial (e.g., steering and data monitoring committees), including any of the following support received:

o Financial: salary support or grants; ownership of stock or options; honoraria (e.g., for advice, authorship, or public speaking); paid consultancy or service on advisory boards; and holding of patents or patents pending

o Non-financial: academic commitments; personal or professional relationships; and political, or other affiliations with special interests or advocacy positions

● Any procedures planned to reduce the risk that conflicts of interest could influence the trial’s design, conduct, analysis, or reporting

● If no conflict of interests, this should be clearly stated