Leading medical journals are to introduce strict guidelines to ensure their scientific objectivity is not compromised by drug companies seeking to influence research findings.
A commentary released by the international committee of medical journal editors (ICMJE) noted that "published evidence of efficacy and safety" was based on the assumption that clinical trials data had been gathered and presented in an objective and dispassionate manner.
"We are concerned that the current intellectual environment in which some clinical research is conceived, study participants are recruited and the data analysed and reported (or not reported) may threaten this precious objectivity," said the ICMJE.
Clinical trials were "powerful tools" and as such must be used with care. "They allow investigators to test biological hypotheses in living patients and they have the potential to change the standards of care."
The "secondary impact of such changes" could be substantial. "Well-done trials published in high-profile journals may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor."
Many clinical trials were intended to hasten regulatory approval of a drug or device rather than to test a scientific hypothesis, said the ICMJE. As trials had become more sophisticated and "the margin of untreated disease harder to reach", the costs of developing new remedies had soared. "It is estimated that the average cost of bringing a new drug to market in the USA is about $500 million."
The pharmaceutical industry had discovered that private, non-academic research groups "could do the job for less money and with fewer hassles" than academic investigators. Such groups now received "the lion's share" of revenues. This meant that corporate sponsors were able to dictate the terms of participation in the trial.
"These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will," said the editors' commentary.
"We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication."