Reproducibility and transparency characteristics of oncology research evidence

Abstract Introduction As much as 50%-90% of research is estimated to be irreproducible, costing upwards of $28 billion in the United States alone. Reproducible research practices are essential to improving the reproducibility and transparency of biomedical research, such as including pre-registering studies, publishing a protocol, making research data and metadata publicly available, and publishing in open access journals. Here we report an investigation of key reproducible or transparent research practices in the published oncology literature. Methods We performed a cross-sectional analysis of a random sample of 300 oncology studies published from 2014-2018. We extracted key reproducibility and transparency characteristics in a duplicative fashion by blinded investigators using a pilot tested Google Form. Results Of the 300 studies randomly sampled, 296 studies were analyzed for study reproducibility characteristics. Of these 296 studies, 194 were contained empirical data that could be analyzed for reproducible and transparent research practices. Raw data was available for 9 studies (4.6%). Approximately 5 studies (2.6%) provided a protocol. Despite our sample including 15 clinical trials and 7 systematic reviews/meta-analyses, only 7 included a pre-registration statement. Less than 25% (65/194) of studies provided an author conflict of interest statement. Discussion We found that key reproducibility and transparency characteristics were absent from a random sample of published oncology studies. We recommend required pre-registration for all eligible trials and systematic reviews, published protocols for all manuscripts, and deposition of raw data and metadata in public repositories.

[1]  J. Ioannidis Why Most Published Research Findings Are False , 2005, PLoS medicine.

[2]  A. Hrõbjartsson,et al.  Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. , 2004, JAMA.

[3]  John P. A. Ioannidis,et al.  Reproducible Research Practices and Transparency across the Biomedical Literature , 2016, PLoS biology.

[4]  C. Begley,et al.  Drug development: Raise standards for preclinical cancer research , 2012, Nature.

[5]  David J Torgerson,et al.  Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals , 2005, BMJ : British Medical Journal.

[6]  Melissa S. Anderson,et al.  Extending the Mertonian Norms: Scientists' Subscription to Norms of Research , 2010, The Journal of higher education.

[7]  B. Gyawali,et al.  Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival , 2019, JAMA network open.

[8]  R. Nuzzo How scientists fool themselves – and how they can stop , 2015, Nature.

[9]  Bradley Voytek,et al.  The Virtuous Cycle of a Data Ecosystem , 2016, PLoS Comput. Biol..

[10]  Zach Hensel,et al.  On the value of preprints: An early career researcher perspective , 2018, PLoS biology.

[11]  Jenine K. Harris,et al.  Use of reproducible research practices in public health: A survey of public health analysts , 2018, PloS one.

[12]  Tim Errington,et al.  Reproducibility Project: Cancer Biology , 2013 .

[13]  Susan Mallett,et al.  A systematic review classifies sources of bias and variation in diagnostic test accuracy studies. , 2013, Journal of clinical epidemiology.

[14]  C. Begg,et al.  Publication bias and dissemination of clinical research. , 1989, Journal of the National Cancer Institute.

[15]  E. von Elm,et al.  Full publication of results initially presented in abstracts. , 2007, The Cochrane database of systematic reviews.

[16]  Francis Tuerlinckx,et al.  Increasing Transparency Through a Multiverse Analysis , 2016, Perspectives on psychological science : a journal of the Association for Psychological Science.

[17]  J. Kaiser Plan to replicate 50 high-impact cancer papers shrinks to just 18 , 2018, Science.

[18]  I. Cockburn,et al.  The Economics of Reproducibility in Preclinical Research , 2015, PLoS biology.

[19]  M. Baker 1,500 scientists lift the lid on reproducibility , 2016, Nature.

[20]  L. V. van Amelsvoort,et al.  False positive outcomes and design characteristics in occupational cancer epidemiology studies. , 2001, International journal of epidemiology.

[21]  R. Kaplan,et al.  Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time , 2015, PloS one.

[22]  F. Prinz,et al.  Believe it or not: how much can we rely on published data on potential drug targets? , 2011, Nature Reviews Drug Discovery.

[23]  P. Glasziou,et al.  Avoidable waste in the production and reporting of research evidence , 2009, The Lancet.

[24]  G. Pond,et al.  Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[25]  M. Vassar,et al.  Evidence of selective reporting bias in hematology journals: A systematic review , 2017, PloS one.

[26]  Brian A. Nosek,et al.  An open investigation of the reproducibility of cancer biology research , 2014, eLife.

[27]  A. Joffe,et al.  The methodological quality of animal research in critical care: the public face of science , 2014, Annals of Intensive Care.

[28]  J. Ioannidis,et al.  Reproducible research practices, transparency, and open access data in the biomedical literature, 2015–2017 , 2018, PLoS biology.

[29]  Roger D. Peng,et al.  The reproducibility crisis in science: A statistical counterattack , 2015 .

[30]  Carl Heneghan,et al.  What is missing from descriptions of treatment in trials and reviews? , 2008, BMJ : British Medical Journal.

[31]  A. Hrõbjartsson,et al.  Promoting public access to clinical trial protocols: challenges and recommendations , 2018, Trials.

[32]  S. Vazire Quality Uncertainty Erodes Trust in Science , 2017 .

[33]  J. Ioannidis Why Science Is Not Necessarily Self-Correcting , 2012, Perspectives on psychological science : a journal of the Association for Psychological Science.

[34]  R. Peng Reproducible Research in Computational Science , 2011, Science.

[35]  Mallory C. Kidwell,et al.  An empirical assessment of transparency and reproducibility-related research practices in the social sciences (2014–2017) , 2019, Royal Society Open Science.

[36]  David Moher,et al.  Comparison of registered and published primary outcomes in randomized controlled trials. , 2009, JAMA.

[37]  J. Celis,et al.  A mission‐oriented approach to cancer in Europe: a joint mission/vision 2030 , 2017, Molecular oncology.

[38]  A. Liberati An unfinished trip through uncertainties , 2004, BMJ : British Medical Journal.

[39]  P. Shekelle,et al.  Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement , 2015, Systematic Reviews.

[40]  Zhen Wang,et al.  Guidelines for reporting meta-epidemiological methodology research , 2017, Evidence-Based Medicine.