Clinical trials published in high-impact journals such as the Lancet or the New England Journal of Medicine (NEJM) have recently come under scrutiny.
Editors from the BMJ and PLOS Open Medicine recently sought to quantify the number of clinical trials in respected, peer-reviewed medical journals that could be classified as 'marketing trials.' While the editors noted the difficulty in determining the true research objective of trials, they endeavoured to classify characteristics of trials which appeared to be marketing oriented.
BMJ editor-in-chief, Fiona Godlee, and her co-authors determined that one-fifth of the original-data clinical trials published in six top medical journals in 2011 could be classified as marketing trials. Notably, they found almost one-third of the trials in NEJM and 23% of the trials of those from the Lancet were marketing trials.
In comparing the groups, the study found those trials classified as marketing had higher rates of funding and participation by the drug manufacturer, as well as a greater median number of trial sites.
A marketing trial is designed principally to highlight data in a manner which portrays a drug in a positive light.
Peer-reviewed journals are the gold standard in medical publishing, and therefore associated with rigorous publishing guidelines. Peer-review aims to ensure quality by adhering to specific standards and conventions. Publication in one is important because it gives a study the imprimatur of research integrity and transparency.
The research team examined 194 randomised clinical trials published in six medical journals over the course of 2011. In addition to the NEJM and the Lancet, the researchers also reviewed studies published in JAMA, the Annals of Internal Medicine, PLOS Medicine, and the BMJ.
The six researchers agreed upon six characteristics suggestive of a marketing trial: a high level of involvement by the drug manufacturer in the study design, data analysis, and reporting of the study (1-3), recruitment of small numbers of patients from multiple study sites for a common disease (4), misleading abstracts (5), and conclusions focusing on secondary endpoints (6).
The researchers also found marketing trials had more clinical trial sites than other clinical trials—a median of 171 sites versus 13 sites. Higher numbers of study sites means more physicians are involved with the product being tested, thereby increasing physician exposure to the product and setting up a potential network of regional key opinion leaders.
The six researchers acknowledge their classifications were necessarily subjective and upfront about their potential conflicts of interest as employees of some of the journals they were studying.
Brought to you by Scope e-Knowledge Center, a world-leading provider of abstraction, indexing, entity extraction and knowledge organisation models (Taxonomies, Thesauri and Ontologies).
