When is a trial just a marketing exercise?

“JOURNALS have devolved into information-laundering operations for the pharmaceutical industry,” Lancet editor Dr Richard Horton wrote in a 2004 article for the New York Review of Books.

The following year, then editor of The BMJ, Dr Richard Smith, asked plaintively: “How might we prevent journals from being an extension of the marketing arm of pharmaceutical companies?”

A decade on, it might be a good time to look at how we’re going on that front.

A recent study of randomised controlled trials published in six of the world’s leading general medicine journals during 2011 found just over 20% seemed to have been conducted “more for marketing purposes than scientific endeavour”.

All of the identified “marketing trials” were funded by industry and many showed industry involvement in study design, analysis and reporting, according to the international team of researchers, which included BMJ editor Dr Fiona Godlee, and Australia’s Dr Virginia Barbour, one of the founding editors of PLOS Medicine.

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Marketing trials were more likely than other trials to focus on surrogate outcomes in their abstracts and to include speculation “that might encourage clinicians to use the intervention outside of the study population”, the team found.

Interestingly, although the marketing trials did not enrol more participants overall, they did recruit them from a much wider range of locations, and often from multiple countries.

The median number of recruiting centres for marketing trials was 171, compared with just 13 for non-marketing trials. As a result, marketing trials had a median of 11 participants per centre, compared with 112 for non-marketing trials.

“Recruitment from multiple sites is more expensive and harder to manage,” the research team wrote.

“The justification[s] for specific recruitment strategies are not typically reported in journal articles, protocols or trial registries so this information can only be gathered from the manufacturers or authors of the study. We tried but failed to obtain this information from individual trial authors.”

You can certainly see how running a trial in more places, and therefore involving a larger number and greater geographical spread of clinicians, could help boost the marketing effort for a new drug or indication.

In fact, it’s a bit hard to see what other motive there might be, given that the diseases studied in these trials were common conditions where, as the team put it, “patients could easily have been recruited from a smaller number of centres in a similar time period, with less risk to data quality and at reduced cost”.

Sadly, neither the authors of the papers studied nor the journals seemed particularly open to discussing such issues.

Only 18% of authors of marketing trials responded to a survey sent by the researchers, compared with 33% of authors of non-marketing trials. The response rate was too low to draw firm conclusions from the data, the researchers wrote.

Editors of the four journals identified as having published marketing studies did respond to the researchers’ inquiries about how they assessed the possible marketing imperatives behind trials, but all denied these had played a key part in any of the studies they published.

The journal editors all cited confidentiality as the reason for refusing a request to share peer reviewers’ reports or notes on editorial decision making.

The nature of marketing trials, or even their existence, is, as these researchers put it, “difficult to prove in the absence of confidential internal company documents”, and they acknowledged the subjective nature of their analysis.

Their study revealed the difficulties of trying to apply a quantitative approach to something as nebulous as a marketing trial, they wrote, suggesting their conclusions were “more suited to start a debate than to settle it”.

“The main issue raised is whether the current system of designing and publishing interventional trials does serve the best interests of patients and health practitioners,” they wrote.

“We hope that this research will trigger further debate on trials and remind editors, peer reviewers and readers of the need to closely scrutinise trials for their design (including recruitment strategies and the role of the product manufacturer in the design, analysis and reporting of the study) as well as their findings.”

Bring it on.

Jane McCredie is a Sydney-based science and medicine writer.