Research, conducted at the Department of Medicine and the Department of Health Research and Policy at Stanford University, has concluded that most medical research findings are false and that most research findings that are not false are not useful. The paper, provocatively entitled “Why Most Clinical Research Is Not Useful”, states that reform and improvement are overdue if clinical research is to have utility in the real world, and if medical interventions are to have practical benefits. Presumably the conclusion does not apply to the author’s current research. The research was conducted by Prof. John Ioannidis, a professor of evidence-based medicine at Stanford University and Director of the Stanford Prevention Research Centre. A previous paper in 2005 by the same author, entitled “Why Most Published Research Findings Are False”, is reported to be the most downloaded technical paper from the PLOS Medicine journal, currently showing article views of >2M.
The research argues that several features of clinical research can be identified and used as a measure of utility, including criteria described as “problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency.” However, despite the ease of identifying such criteria the author claims that many studies that are published in the mainstream journals do not satisfy these criteria and very few studies would satisfy most or all of them. For example, in respect of evaluating the quantity of research in proportion to the magnitude of healthcare problems, data suggests that there is only a weak or modest correlation between the amount of research done and the burden of various diseases. In addition, the research suggests that proposed surrogate outcomes in trials do not always reflect clinically meaningful measures, while transparency in the conduct and publication of full study clinical reports significantly lags behind the required level necessary to support independent audit, evaluation and validation. The study also claims that independent research indicates that over 90% of the cost of clinical trials could be safely eliminated.
Interestingly, the Stanford University paper suggests that preclinical research should be funded by entrepreneurs and industry, given that such research generally has some practical application, such as a therapeutic intervention, procedure or diagnostic, and consequently, such funders would stand to profit from successful technologies. However, it may be challenging for any entrepreneur or industrialist to support an early stage/preclinical technology which, in respect of some analysis, could take up to 25 years or more to reach market. It is unclear on what basis an entrepreneur or industrialist would make such investments over such time periods, given the opportunity costs of investment funds and the normal economic behaviour of any entrepreneur to obtain an optimal return on scarce investment resources within an optimal timeframe.