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A call for transparent reporting to optimize the predictive value of preclinical research
Open accessAbstract
Deficiencies in methods reporting in animal experimentation lead to difficulties in reproducing experiments; the authors propose a set of reporting standards to improve scientific communication and study design. Animal studies have contributed immensely to our understanding of diseases and assist the development of new therapies, but inadequate experimental reporting can sometimes render such studies difficult to reproduce and to translate into the clinic. This year, a US National Institute of Neurological Disorders and Stroke workshop addressed this issue, and its conclusions are discussed in a Perspective piece in this issue of Nature. The main workshop recommendation is that at a minimum, studies should report on randomization, blinding, sample-size estimation and how the data were handled. The US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the methodological reporting of animal studies in grant applications and publications. The main workshop recommendation is that at a minimum studies should report on sample-size estimation, whether and how animals were randomized, whether investigators were blind to the treatment, and the handling of data. We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators, reviewers, funding agencies and journal editors. Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress.
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“In a hypothesis-testing study powered to detect an effect on the primary outcome measure, data on secondary outcomes are used to evaluate additional effects of the intervention, but subsequent statistical analysis of secondary outcome measures may be underpowered, making results and interpretation less reliable [88,93].”
From Reporting animal research: Explanation and elaboration for the ARRIVE guidelines 2.0 (2020) · cites this paper as [93]
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“In contrast, greater use of measures to control risk of bias in animal experiments, such as randomization and blinding (Landis et al., 2012), was correlated with greater effect size decreases in replications.”
From Estimating the replicability of Brazilian biomedical science (2025) · cites this paper as Landis et al., 2012
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“Other factors have been identified that could improve replicability, such as blinding, randomization, and sample size planning (Landis et al., 2012; Macleod and Mohan, 2019).”
From Investigating the replicability of preclinical cancer biology (2021) · cites this paper as Landis et al., 2012
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“The low replication success rates and small effect sizes we found reinforce prior calls for improving the rigor and transparency of preclinical research to improve the allocation of limited resources and to protect human participants from being enrolled in trials that are based on weak evidence”
From Investigating the replicability of preclinical cancer biology (2021) · cites this paper as Landis et al., 2012
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“By providing a comprehensive set of recommendations that are specifically tailored to the description of in vivo research, they help authors reporting animal experiments adhere to the National Institutes of Health (NIH) standards [43] and the minimum standards framework and checklist (Materials, Design, Analysis and Reporting [MDAR] [47]).”
From The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research (2020) · cites this paper as [43]
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“The standards have been adopted by the National Institutes of Health (8,70).”
From Radiomics: Images Are More than Pictures, They Are Data (2016) · cites this paper as [70]
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Citations
Cites
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · BMC Medicine · doi:10.1186/1741-7015-8-18 · Cited by 13,371
Why Most Published Research Findings Are False
Ioannidis, J. P. A. (2005) · PLoS Medicine · doi:10.1371/journal.pmed.0020124 · Cited by 10,505
The file drawer problem and tolerance for null results.
Rosenthal, R. (1979) · Psychological Bulletin · doi:10.1037/0033-2909.86.3.638 · Cited by 9,068
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883
Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research
Kilkenny, C., Browne, W. J., Cuthill, I. C., Emerson, M., & Altman, D. G. (2010) · PLoS Biology · doi:10.1371/journal.pbio.1000412 · Cited by 7,300
Simmons, J. P., Nelson, L. D., & Simonsohn, U. (2011) · Psychological Science · doi:10.1177/0956797611417632 · Cited by 6,567
Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research
Kilkenny, C., Browne, W. J., Cuthill, I. C., Emerson, M., & Altman, D. G. (2010) · Journal of Pharmacology and Pharmacotherapeutics · doi:10.4103/0976-500x.72351 · Cited by 6,277
Schulz (1995) · doi:10.1001/jama.1995.03520290060030 · Cited by 5,634
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373
Why Most Published Research Findings Are False
Ioannidis, J. P. A. (2005) · CHANCE · doi:10.1080/09332480.2005.10722754 · Cited by 4,702
Cited by
Metadata
- Authors
- Landis, S. C., Amara, S. G., Asadullah, K., Austin, C. P., Blumenstein, R., Bradley, E. W., Crystal, R. G., Darnell, R. B., Ferrante, R. J., Fillit, H., Finkelstein, R., Fisher, M., Gendelman, H. E., Golub, R. M., Goudreau, J. L., Gross, R. A., Gubitz, A. K., Hesterlee, S. E., Howells, D. W., Huguenard, J., Kelner, K., Koroshetz, W., Krainc, D., Lazic, S. E., Levine, M. S., Macleod, M. R., McCall, J. M., Moxley III, R. T., Narasimhan, K., Noble, L. J., Perrin, S., Porter, J. D., Steward, O., Unger, E., Utz, U., & Silberberg, S. D.
- Affiliations
- National Institutes of Health (US)
- University of Pittsburgh (US)
- Bayer (Germany) (DE)
- CHDI Foundation (US)
- Cornell University (US)
- Howard Hughes Medical Institute (US)
- Alzheimer's Drug Discovery Foundation (US)
- University of Massachusetts Chan Medical School (US)
- University of Nebraska Medical Center (US)
- American Medical Association (US)
- Michigan State University (US)
- University of Rochester Medicine (US)
- Parent Project Muscular Dystrophy (US)
- The University of Melbourne (AU)
- Stanford University (US)
- American Association For The Advancement of Science (US)
- Harvard University (US)
- F. Hoffmann-La Roche AG (CH)
- University of California, Los Angeles (US)
- Western General Hospital (GB)
- Amyotrophic Lateral Sclerosis Therapy Development Institute (US)
- University of California, Irvine (US)
- United States Food and Drug Administration (US)
- Corresponding author
- Silberberg, Shai D.
- ORCID
- Amara, Susan G.
- Crystal, Ronald G.
- Darnell, Robert B.
- Fillit, Howard
- Fisher, Marc
- Gendelman, Howard E.
- Goudreau, John L.
- Gross, Robert A.
- Howells, David W.
- Huguenard, John
- Koroshetz, Walter
- Krainc, Dimitri
- Lazic, Stanley E.
- Macleod, Malcolm R.
- Porter, John D.
- Steward, Oswald
- Unger, Ellis
- Utz, Ursula
- Silberberg, Shai D.
- Venue
- Nature
- Published
- 2012-10
- Volume
- 490
- Issue
- 7419
- Pages
- 187-191
- ISSN
- 0028-0836 (ISSN-L)
- 1476-4687
- PMC
- PMC3511845
- OpenAlex
- W2137516955
- Cited by
- 1,196
- References
- 71
- Citations by year
- 2026: 45 · 2025: 57 · 2024: 40 · 2023: 72 · 2022: 68 · 2021: 80 · 2020: 91 · 2019: 87 · 2018: 79 · 2017: 116 · 2016: 136 · 2015: 129 · 2014: 115 · 2013: 68 · 2012: 12
- FWCI
- 149.45
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Nature (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- The Journal of the American Medical Association (JAMA) Network (American Medical Association) (submittedVersion, cc-by-nc-sa)
- RePEc: Research Papers in Economics (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-sa)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Funders
- National Institutes of Health (Z99 NS999999, 5t32ns007280-35)
- National Institute of Mental Health (P30MH062261, T32MH020016)
- National Institute of Neurological Disorders and Stroke (T32NS-007280, P01NS012151, R01NS041574, R01NS034774, R01NS006477)
- National Center for Research Resources (UL1RR024160)
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Library and Information Sciences › Academic Publishing and Open Access
- Keywords
- animal experimentation, preclinical research, reporting guidelines, reproducibility, sample size determination, randomization, blinding, data handling, translational research, grant applications, peer review
- MeSH terms
- Animals, Publishing, Random Allocation, Research Design, Statistics as Topic, Sample Size
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