Innovation is important for the development of medicine. However, the present state in which published articles are not trustworthy because of fraud, methodological issues, conflicts of interest or inappropriate peer review, is untenable. Research results should be reliable, transparent and easily interpretable for decision makers, researchers and patients. The present situation where research results may be misleading, exaggerated or plain wrong means that applying new findings to the clinic (e.g. new high-price cancer drugs) should be performed very cautiously, especially if the evidence is not based on rigorous, robust, high-quality, transparent studies. The current situation inevitably leads to waste of resources and ultimately may put patients’ lives at risk.
During the period 2000–2010 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprieties . It is estimated that US$240 billion is spent globally every year on health research. The output from this research is documented in about 3 million articles of which around half are published by 6,000 publishers in 25,000 journals (with a much larger number of editors) . The status quo is “unprofessional, arguably unethical and certainly unacceptable” . However, since medical research is complex, there is no simple solution. Many initiatives have been suggested to improve the quality of research.
One fundamental issue is that authors need training in writing articles based on the principles of “responsible conduct of research”. Therefore, at least those studies that are publicly funded should have the design and methodology approved. A “publication office” to approve the science before funding has been proposed . A second issue is improvement in the peer review process. A huge body of evidence shows that editors and reviewers need education. The transparency of the review process also needs to be improved. Conflicts of interest (especially ties to industry) and the expertise of the assessment team, and whether the editorial decision making is dependent on or independent of economic considerations, need to be made clear. A third aspect is to secure open access to research data so that studies can be scrutinized after publication by other researchers, eventually leading to retraction of poor studies. There is growing agreement on this issue, but how it should be achieved in practice is still a matter of debate. It is encouraging that the European Medicines Agency (EMA) has started to publish all data on clinical trials. Verification of reported research data is crucial to ensure reliability. Although there is no consensus as to how repeatability should be defined and achieved, it is crucial that repeat studies are founded on robust and transparent designs.