Guidelines for Researchers Involved in Manufacturer-Sponsored Trials
As medical research of drugs and devices has evolved, the quality of available evidence has benefited from increasing numbers of well designed randomized controlled trials, leading directly to reductions in selection bias. An additional source of potential bias is found when manufacturers with interests vested in positive trial outcomes sponsor trials themselves. In order to reduce this type of bias, the following guidelines are presented for medical journals that publish manufacturer-sponsored research. These guidelines are meant to supplement authorship disclosure of potential conflicts.
Recommended supplement to authorship guidelines
Manufacturers sponsoring trials should make significant efforts to remove individual investigators from potential funding bias. To this end, study protocols should be initiated by investigators who are neither compensated nor employed by the manufacturer. Such trials should be executed and their results analyzed without any contribution from the study sponsors. Additionally, trial reports should be written entirely by the study authors and not be sent to agents of the sponsoring manufacturer for prepublication review.
Authors who submit manuscripts according to these guidelines are encouraged to include the following language in their Methods:
"The manufacturer, XXX, donated medications and funding for the trial, but agreed that the trial be conducted independently in order to reduce funding bias. This agreement specified that results of the trial could be published in the particular case where an outcome could negatively impact the manufacturer’s market value. Accordingly, the trial was designed, conducted, analyzed, interpreted, and written by investigators independent of XXX, and was not sent to agents of XXX for prepublication review or approval."
For review articles, authors should explicitly state that they are directly responsible for writing.
Substitute authoring (also known as "ghost writing") should be clearly identified.
Recommendations to editors
Manuscripts from manufacturer-sponsored trials where efforts have been made to eliminate funding bias should be given priority for publication over similar manuscripts where funding bias remains possible. Employees of sponsors must be clearly identified if involved in manuscript authorship. Any other relationships between authors and sponsors must also be clearly identified within the author section of the publication.
Recommended supplement to expert guideline classification
In addition to classifying research evidence by trial design (where, for example, a randomized controlled trial is considered Level I evidence), expert guidelines should also denote potential funding bias. The highest level of evidence should be reserved for randomized controlled trials that are clearly independent of such bias.
Approved: June 25, 2002