Using the concept of “deserved trust” to strengthen the value and integrity of biomedical research

References

• Abritis, A., A. Marcus, and I. Oransky. 2020. “An ‘Alarming’ and ‘Exceptionally High’ Rate of COVID-19 Retractions?” Accountability in Research 1–2. doi:https://doi.org/10.1080/08989621.2020.1793675.
   Web of Science ®Google Scholar
• Agiesta, J. 2020. “CNN Poll: Most Americans Would Be Uncomfortable Returning to Regular Routines Today.” CNN. Accessed 11 July 2020. https://www.cnn.com/2020/05/12/politics/cnn-poll-americans-uncomfortable-routines/index.html
   Google Scholar
• Barnett, A. G., and D. Moher. 2019. “Turning the Tables: A University League-Table Based on Quality Not Quantity [Version 1; Peer Review: 1 Approved].” F1000Research 8: 583. doi:https://doi.org/10.12688/f1000research.18453.1.
   PubMedGoogle Scholar
• Begley, C. G., and L. M. Ellis. 2012. “Drug Development: Raise Standards for Preclinical Cancer Research.” Nature 483 (7391): 531–533. doi:https://doi.org/10.1038/483531a.
   PubMed Web of Science ®Google Scholar
• Benedictus, R., F. Miedema, and M. W. Ferguson. 2016. “Fewer Numbers, Better Science.” Nature 538 (7626): 453–455. doi:https://doi.org/10.1038/538453a.
   PubMed Web of Science ®Google Scholar
• Cicerone, R. J. 2010. “Ensuring Integrity in Science.” Science 327 (5966): 624. doi:https://doi.org/10.1126/science.1187612.
   PubMed Web of Science ®Google Scholar
• Collins, F. S., and L. A. Tabak. 2014. “Policy: NIH Plans to Enhance Reproducibility.” Nature 505 (7485): 612–613. doi:https://doi.org/10.1038/505612a.
   PubMed Web of Science ®Google Scholar
• Crossley, N. A., E. Sena, J. Goehler, J. Horn, B. van der Worp, P. M. Bath, M. Macleod, and U. Dirnagl. 2008. “Empirical Evidence of Bias in the Design of Experimental Stroke Studies: A Metaepidemiologic Approach.” Stroke 39 (3): 929–934. doi:https://doi.org/10.1161/STROKEAHA.107.498725.
   PubMed Web of Science ®Google Scholar
• Deutsche Forschungsgemeinschaft. 2019. “Recommendations for the Promotion of Translational Research in University Medicine.” https://www.dfg.de/download/pdf/dfg_im_profil/reden_stellungnahmen/2019/190919_stellungnahme_empfehlung_ag_translation.pdf
   Google Scholar
• Dirnagl, U. 2020. “Preregistration of Exploratory Research: Learning from the Golden Age of Discovery.” PLoS Biology 18 (3): e3000690. doi:https://doi.org/10.1371/journal.pbio.3000690.
   PubMed Web of Science ®Google Scholar
• Egan, K. J., H. M. Vesterinen, V. Beglopoulos, E. S. Sena, and M. R. Macleod. 2016. “From a Mouse: Systematic Analysis Reveals Limitations of Experiments Testing Interventions in Alzheimer’s Disease Mouse Models.” Evidence-Based Preclinical Medicine 3 (1): e00015. doi:https://doi.org/10.1002/ebm2.15.
   PubMedGoogle Scholar
• Enserink, M. 2017. “Sloppy Reporting on Animal Studies Proves Hard to Change.” Science 357 (6358): 1337–1338. doi:https://doi.org/10.1126/science.357.6358.1337.
   PubMed Web of Science ®Google Scholar
• Garner, J. P., B. N. Gaskill, E. M. Weber, J. Ahloy-Dallaire, and K. R. Pritchett-Corning. 2017. “Introducing Therioepistemology: The Study of How Knowledge Is Gained from Animal Research.” Lab Animal 46 (4): 103–113. doi:https://doi.org/10.1038/laban.1224.
   Web of Science ®Google Scholar
• Goldacre, B., N. J. DeVito, C. Heneghan, F. Irving, S. Bacon, J. Fleminger, and H. Curtis. 2018. “Compliance with Requirement to Report Results on the EU Clinical Trials Register: Cohort Study and Web Resource.” BMJ 362 (September): k3218. doi:https://doi.org/10.1136/bmj.k3218.
   PubMedGoogle Scholar
• Hakala, A. K., D. Fergusson, and J. Kimmelman. 2017. “Nonpublication of Trial Results for New Neurological Drugs: A Systematic Review.” Annals of Neurology 81 (6): 782–789. doi:https://doi.org/10.1002/ana.24952.
   PubMed Web of Science ®Google Scholar
• Hardin, R. Trust and Trustworthiness. Russell Sage Foundation, 2002, New York, New York.
   Google Scholar
• Hartung, T. 2013. “Food for Thought Look Back in Anger – What Clinical Studies Tell Us about Preclinical Work.” ALTEX 30 (3): 275–291. doi:https://doi.org/10.14573/altex.2013.3.275.
   PubMedGoogle Scholar
• Hilal, T., M. Gonzalez-Velez, and V. Prasad. 2020. “Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.” JAMA Internal Medicine 180 (8, June): 1108. doi:https://doi.org/10.1001/jamainternmed.2020.2250.
   PubMed Web of Science ®Google Scholar
• Hirst, J. A., J. Howick, J. K. Aronson, N. Roberts, R. Perera, C. Koshiaris, and C. Heneghan. 2014. “The Need for Randomization in Animal Trials: An Overview of Systematic Reviews.” PLoS One 9 (6): e98856. doi:https://doi.org/10.1371/journal.pone.0098856.
   PubMed Web of Science ®Google Scholar
• Howells, D. W., E. S. Sena, and M. R. Macleod. 2014. “Bringing Rigour to Translational Medicine.” Nature Reviews. Neurology 10 (1): 37–43. doi:https://doi.org/10.1038/nrneurol.2013.232.
   PubMed Web of Science ®Google Scholar
• Institute of Medicine. 2013. Sharing Clinical Research Data: WorkshopSummary. Washington, DC: National Academies Press (US); 2013 Mar 29. 9780309268745 0309268745.
   Google Scholar
• Ioannidis, J. P. A. 2017. “Acknowledging and Overcoming Nonreproducibility in Basic and Preclinical Research.” JAMA 317 (10): 1019–1020. doi:https://doi.org/10.1001/jama.2017.0549.
   PubMed Web of Science ®Google Scholar
• Jefferson, T., and L. Jorgensen. 2018. “Redefining the ‘E’ in EBM.” BMJ Evidence-Based Medicine 23 (2): 46–47. doi:https://doi.org/10.1136/bmjebm-2018-110918.
   PubMedGoogle Scholar
• Joseph, A. 2020. “Lancet, NEJM Retract Covid-19 Studies That Sparked Backlash.” STAT (blog), June 4. https://www.statnews.com/2020/06/04/lancet-retracts-major-covid-19-paper-that-raised-safety-concerns-about-malaria-drugs/
   Google Scholar
• Kilkenny, C., W. J. Browne, I. C. Cuthill, M. Emerson, and D. G. Altman. 2010. “Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research.” PLoS Biology 8 (6): e1000412. doi:https://doi.org/10.1371/journal.pbio.1000412.
   PubMed Web of Science ®Google Scholar
• Kimmelman, J., and A. J. London. 2015. “The Structure of Clinical Translation: Efficiency, Information, and Ethics.” The Hastings Center Report 45 (2): 27–39. doi:https://doi.org/10.1002/hast.433.
   PubMed Web of Science ®Google Scholar
• Kimmelman, J., J. S. Mogil, and U. Dirnagl. 2014. “Distinguishing between Exploratory and Confirmatory Preclinical Research Will Improve Translation.” PLoS Biology 12 (5): e1001863. doi:https://doi.org/10.1371/journal.pbio.1001863.
   PubMed Web of Science ®Google Scholar
• Lindner, M. D. 2007. “Clinical Attrition Due to Biased Preclinical Assessments of Potential Efficacy.” Pharmacology & Therapeutics 115 (1): 148–175. doi:https://doi.org/10.1016/j.pharmthera.2007.05.002.
   PubMed Web of Science ®Google Scholar
• Lund, H., K. Brunnhuber, C. Juhl, K. Robinson, M. Leenaars, B. F. Dorch, G. Jamtvedt, M. W. Nortvedt, R. Christensen, and I. Chalmers. 2016. “Towards Evidence Based Research.” BMJ 355 (October): i5440. doi:https://doi.org/10.1136/bmj.i5440.
   PubMedGoogle Scholar
• Macleod, M. R., A. L. McLean, A. Kyriakopoulou, S. Serghiou, A. de Wilde, N. Sherratt, T. Hirst, R. Hemblade, Z. Bahor, C. Nunes-Fonseca, et al. 2015. “Risk of Bias in Reports of in Vivo Research: A Focus for Improvement.” PLoS Biology 13 (10): e1002273. doi:https://doi.org/10.1371/journal.pbio.1002273.
   PubMed Web of Science ®Google Scholar
• Matthews, D. 2020. “French Trust in Science Drops as Coronavirus Backlash Begins.” Times Higher Education (THE), June 8. https://www.timeshighereducation.com/news/french-trust-science-drops-coronavirus-backlash-begins
   Google Scholar
• Mejlgaard, N., L. M. Bouter, G. Gaskell, P. Kavouras, N. Allum, A.-K. Bendtsen, C. A. Charitidis, N. Claesen, K. Dierickx, A. Domaradzka, et al. 2020. “Research Integrity: Nine Ways to Move from Talk to Walk.” Nature 586 (7829): 358–360. doi:https://doi.org/10.1038/d41586-020-02847-8.
   PubMed Web of Science ®Google Scholar
• Minnerup, J., U. Dirnagl, and W. R. Schabitz. 2020. “Checklists for Authors Improve the Reporting of Basic Science Research.” Stroke 51 (1): 6–7. doi:https://doi.org/10.1161/STROKEAHA.119.027626.
   PubMed Web of Science ®Google Scholar
• Moher, D., P. Glasziou, I. Chalmers, M. Nasser, P. M. Bossuyt, D. A. Korevaar, I. D. Graham, P. Ravaud, and I. Boutron. 2016. “Increasing Value and Reducing Waste in Biomedical Research: Who’s Listening?” Lancet 387 (10027): 1573–1586. doi:https://doi.org/10.1016/S0140-6736(15)00307-4.
   PubMed Web of Science ®Google Scholar
• Nature. 2010. “A Question of Trust.” Nature 466 (7302): 7. doi:https://doi.org/10.1038/466007a.
   Web of Science ®Google Scholar
• Nosek, B. A., C. R. Ebersole, A. C. DeHaven, and D. T. Mellor. 2018. “The Preregistration Revolution.” Proceedings of the National Academy of Sciences 115 (11): 2600. doi:https://doi.org/10.1073/pnas.1708274114.
   PubMed Web of Science ®Google Scholar
• O’Connor, A. M., and J. M. Sargeant. 2014. “Critical Appraisal of Studies Using Laboratory Animal Models.” ILAR Journal 55 (3): 405–417. doi:https://doi.org/10.1093/ilar/ilu038.
   PubMed Web of Science ®Google Scholar
• Peers, I. S., M. C. South, P. R. Ceuppens, J. D. Bright, and E. Pilling. 2014. “Can You Trust Your Animal Study Data?” Nature Reviews. Drug Discovery 13 (7): 560. doi:https://doi.org/10.1038/nrd4090-c1.
   PubMed Web of Science ®Google Scholar
• Perrin, S. 2014. “Preclinical Research: Make Mouse Studies Work.” Nature News 507 (7493): 423. doi:https://doi.org/10.1038/507423a.
   PubMed Web of Science ®Google Scholar
• Reichlin, T. S., L. Vogt, and H. Würbel. 2016. “The Researchers’ View of Scientific Rigor—Survey on the Conduct and Reporting of in Vivo Research.” PLoS One 11 (12): e0165999. doi:https://doi.org/10.1371/journal.pone.0165999.
   PubMed Web of Science ®Google Scholar
• “Reporting Standards and Availability of Data, Materials, Code and Protocols.” n.d. https://www.nature.com/nature-research/editorial-policies/reporting-standards
   Google Scholar
• Riveros, C., A. Dechartres, E. Perrodeau, R. Haneef, I. Boutron, and P. Ravaud. 2013. “Timing and Completeness of Trial Results Posted at ClinicalTrials.Gov and Published in Journals.” PLoS Medicine 10 (12): e1001566; discussion e1001566. doi:https://doi.org/10.1371/journal.pmed.1001566.
   Google Scholar
• Robinson, K. A., and S. N. Goodman. 2011. “A Systematic Examination of the Citation of Prior Research in Reports of Randomized, Controlled Trials.” Annals of Internal Medicine 154 (1): 50–55. doi:https://doi.org/10.7326/0003-4819-154-1-201101040-00007.
   PubMed Web of Science ®Google Scholar
• Schmidt-Pogoda, A., N. Bonberg, M. H. M. Koecke, J. K. Strecker, J. Wellmann, N. M. Bruckmann, C. Beuker, W-R. Schabitz, S. Meuth, H. Wiendl, H. Minnerup, J. Minnerup. 2019. “Why Most Acute Stroke Studies are Positive in Animals but Not in Patients.” Annals of Neurology, November. doi:https://doi.org/10.1002/ana.25643.
   Google Scholar
• Sena, E. S., H. B. van der Worp, P. M. Bath, D. W. Howells, and M. R. Macleod. 2010. “Publication Bias in Reports of Animal Stroke Studies Leads to Major Overstatement of Efficacy.” PLoS Biology 8 (3): e1000344. doi:https://doi.org/10.1371/journal.pbio.1000344.
   PubMed Web of Science ®Google Scholar
• Sert, N. P. D., A. Ahluwalia, S. Alam, M. T. Avey, M. Baker, W. J. Browne, A. Clark, et al. 2020. “Reporting Animal Research: Explanation and Elaboration for the ARRIVE Guidelines 2.0.” PLoS Biology 18 (7): e3000411. doi:https://doi.org/10.1371/journal.pbio.3000411.
   PubMed Web of Science ®Google Scholar
• Smith, R. 2014. “Richard Smith: Why Scientists Should Be Held to a Higher Standard of Honesty than the Average Person.” The BMJ. September, https://blogs.bmj.com/bmj/2014/09/02/richard-smith-why-scientists-should-be-held-to-a-higher-standard-of-honesty-than-the-average-person/.
   Google Scholar
• Strand, L. B., P. Clarke, N. Graves, and A. G. Barnett. 2017. “Time to Publication for Publicly Funded Clinical Trials in Australia: An Observational Study.” BMJ Open 7 (3): e012212. doi:https://doi.org/10.1136/bmjopen-2016-012212.
   PubMed Web of Science ®Google Scholar
• Tsilidis, K. K., O. A. Panagiotou, E. S. Sena, E. Aretouli, E. Evangelou, D. W. Howells, R. A.-S. Salman, M. R. Macleod, and J. P. A. Ioannidis. 2013. “Evaluation of Excess Significance Bias in Animal Studies of Neurological Diseases.” Edited by Lisa Bero. PLoS Biology 11 (7): e1001609. doi:https://doi.org/10.1371/journal.pbio.1001609.
   PubMed Web of Science ®Google Scholar
• Vogt, L., T. S. Reichlin, C. Nathues, and W. Hanno. 2016. “Authorization of Animal Experiments Is Based on Confidence Rather than Evidence of Scientific Rigor.” PLoS Biology 14 (12): 12. doi:https://doi.org/10.1371/journal.pbio.2000598.
   Web of Science ®Google Scholar
• Wadman, M. 2010.“NIH to Tighten Rules on Conflicts.” Nature, May. doi:https://doi.org/10.1038/news.2010.257.
   Google Scholar
• Ware, J. J., and M. R. Munafo. 2014.“Significance Chasing in Research Practice: Causes, Consequences and Possible Solutions.” Addiction, July. doi:https://doi.org/10.1111/add.12673.
   Web of Science ®Google Scholar
• Wieschowski, S., W. W. L. Chin, C. Federico, S. Sievers, J. Kimmelman, and D. Strech. 2018. “Preclinical Efficacy Studies in Investigator Brochures: Do They Enable Risk-Benefit Assessment?” PLOS Biology 16 (4): e2004879. doi:https://doi.org/10.1371/journal.pbio.2004879.
   PubMed Web of Science ®Google Scholar
• Willmann, R., J. Lee, C. Turner, K. Nagaraju, A. Aartsma-Rus, D. J. Wells, K. R. Wagner, et al. 2020. “Improving Translatability of Preclinical Studies for Neuromuscular Disorders: Lessons from the TREAT-NMD Advisory Committee for Therapeutics (TACT).” Disease Models & Mechanisms 13 (2): dmm042903. doi:https://doi.org/10.1242/dmm.042903.
   PubMed Web of Science ®Google Scholar
• Yarborough, M. 2014a. “Taking Steps to Increase the Trustworthiness of Scientific Research.” The FASEB Journal 28 (9): 3841–3846. doi:https://doi.org/10.1096/fj.13-246603.
   PubMed Web of Science ®Google Scholar
• Yarborough, M. 2014b. “Openness in Science Is Key to Keeping Public Trust.” Nature News 515 (7527): 313. doi:https://doi.org/10.1038/515313a.
   PubMed Web of Science ®Google Scholar
• Yarborough, M. 2020a. “Rescuing Informed Consent: How the New ‘Key Information’ and ‘Reasonable Person’ Provisions in the Revised U.S. Common Rule Open the Door to Long Overdue Informed Consent Disclosure Improvements and Why We Need to Walk through that Door.” Science and Engineering Ethics 26 (3): 1423–1443. doi:https://doi.org/10.1007/s11948-019-00170-8.
   PubMed Web of Science ®Google Scholar
• Yarborough, M. 2020b. “Do We Really Know How Many Clinical Trials are Conducted Ethically? Why Research Ethics Committee Review Practices Need to Be Strengthened and Initial Steps We Could Take to Strengthen Them.” Journal of Medical Ethics, June: medethics-2019-106014. doi:https://doi.org/10.1136/medethics-2019-106014.
   Google Scholar
• Yarborough, M., A. Bredenoord, F. D’Abramo, N. C. Joyce, J. Kimmelman, U. Ogbogu, E. Sena, D. Strech, and U. Dirnagl. 2018. “The Bench Is Closer to the Bedside than We Think: Uncovering the Ethical Ties between Preclinical Researchers in Translational Neuroscience and Patients in Clinical Trials.” PLOS Biology 16 (6): e2006343. doi:https://doi.org/10.1371/journal.pbio.2006343.
   PubMed Web of Science ®Google Scholar
• Yarborough, M., R. Nadon, and D. G. Karlin. 2019. “Four Erroneous Beliefs Thwarting More Trustworthy Research.” ELife 8 (July): e45261. doi:https://doi.org/10.7554/eLife.45261.
   PubMedGoogle Scholar
• Zarin, D. A., S. N. Goodman, and J. Kimmelman. 2019. “Harms From Uninformative Clinical Trials.” JAMA 322 (9): 813–814. doi:https://doi.org/10.1001/jama.2019.9892.
   PubMed Web of Science ®Google Scholar