Albert Einstein is said to have said that the theory should be as simple as possible, but not simple. By the same token, biomedical researchers doing in vivo experiments should use as few animals as possible, but no fewer.
On page 271, Nature reports a move by UK government funding agencies to require grant applicants to show how they calculated the number of animals needed to make the results of an experiment statistically robust.
In recent years there have been concerns that sample sizes may be too small in individual experiments, particularly in preclinical research that attempts to determine whether a drug is worth pursuing in human studies.
Very small sample sizes can lead to promising drugs being discarded when their effectiveness is missed, or false positives, as well as ethical issues if animals are being used in studies that provide reliable results. are too small for.
The move by UK research councils is to be commended. And the UK is not alone in pursuing such improvements: The US National Institutes of Health is testing the use of a grant-reviewed checklist that includes features such as experimental design to improve the reproducibility of preclinical research in animals .
This should not be a burden on the funding bodies alone. Institutions should also increase the amount of assistance they provide to researchers in designing the statistical aspects of an experiment. Such support is often limited or ad hoc: study design is complex and requires careful consideration by those who truly understand the issues (see Nature 506, 131–132; 2014).
Journals are also responsible for ensuring that the research they publish is reported in sufficient detail for readers to fully appreciate the key details of experimental and analytical design. Several publications – including Nature – have supported the advent guidelines for reporting animal research (C. Kilkenny et al. PLOS Biol. 8, E1000412; 2010). However, these are very detailed, and compliance at this level is difficult for preliminary, exploratory research.
Magazines published by Nature Publishing Group nonetheless encourage the use of ARRIVE. In 2013, we implemented a reporting checklist that demanded that authors provide key details of the study design. For animal studies, these include methods for sample-size determination, randomization and study blinding, as well as exclusion criteria (see Nature 496, 398; 2013). An impact analysis on the effectiveness of the changes introduced in 2013 is currently underway.
Sample size is one of the suite of issues that need to be addressed to combat poor reproducibility. Journals play an important role in dealing with this problem, but others should do the same. Credit to the academies that are leading.
This month, for example, the UK Academy of Medical Sciences held a meeting in London in which researchers, funders and representatives from research institutes and universities discussed improving fertility by examining case studies in topics ranging from epidemiology to particle physics.
Tried to provide recommendations for Exploring the role of culture and encouragement. There are no magic bullets – all parts of the research community need to address the problem.
Undoubtedly, part of the challenge is the culture that drives investigators in many parts of the world to produce more and more with the same resources. The campaign to maximize the number of papers and the impact of the findings is widespread.
In a commentary published last year in Nature Biotechnology, experimental psychologist Marcus Munaf and his colleagues compared modern biomedical research with the automobile industry of the 1970s (M. Munaf et al. Nature Biotechnol. 32, 871-873; 2014). ). The rapidly moving but error-prone car production lines of the United States lost themselves to Japanese manufacturers, who emphasized the importance of quality-control at every step in their factories.
Moral of the story: Quality assurance adds a burden, but it is well worth the effort to gain long-term public trust. Ensuring that the power of an animal experiment fits its purpose is an important way for funders and researchers to contribute.