Transparency Supplemental Reading List

Articles on key topics relevant to transparency in the publication of industry-sponsored research.

Predatory Journals and Congresses

Cobey KD, et al. Knowledge and motivations of researchers publishing in presumed predatory journals: A survey.
BMJ Open. 2019;9(3):e026516. doi: 10.1136/bmjopen-2018-026516.

Cohen AJ, et al. Perspectives from authors and editors in the biomedical disciplines on predatory journals: Survey study.
J Med Internet Res. 2019;21(8): e13769. doi: 10.2196/13769.

Dal-Ré R, Marušić A. Potential predatory journals are colonizing the ICMJE recommendations list of followers.
Neth J Med. 2019;77(2):92-96.

Fiala C, et al. The growing problem of predatory publishing: A case report.
Clin Chem Lab Med. 2019. doi: 10.1515/cclm-2019-0798.

Grudniewicz A, et al. Predatory journals: no definition, no defence.
Nature. 2019;576(7786):210-212. doi: 10.1038/d41586-019-03759-y.

Memon AR. Revisiting the term predatory open access publishing.
J Korean Med Sci. 2019; 34(13):e99. doi: 10.3346/jkms.2019.34.e99.

Richtig G, et al. Awareness of predatory journals and open access among medical oncologists: results of an online survey.
ESMO Open. 2019;4(6):e000580. doi: 10.1136/esmoopen-2019-000580

Ruiter-Lopez L, et al. Predatory journals: Do not judge journal by their Editorial Board Members.
Med Teach. 2019;1-6. doi: 10.1080/0142159X.2018.1556390.

Strinzel M, et al. Blacklists and whitelists to tackle predatory publishing: a cross-sectional comparison and thematic analysis.
MBio. 2019;10(3). pii: e00411-19. doi: 10.1128/mBio.00411-19.

Wyatt JC. Preserving the open access benefits pioneered by the Journal of Medical Internet Research and discouraging fraudulent journals.
J Med Internet Res. 2019;21(12):e16532. doi: 10.2196/16532.

Baker EF, et al. Open access medical journals: promise, perils, and pitfalls.
Acad Med. 2018 Dec 18. doi: 10.1097/ACM.0000000000002563. [Epub ahead of print].

Bowman MA, et al. Beware of predatory journals: A caution from editors of three family medicine journals.
J Am Board Fam Med. 2018;31(5):671-676. doi: 10.3122/jabfm.2018.05.180197.

Cobey KD, et al. What is a predatory journal? A scoping review. Version 2.
F1000Res. 2018 Jul 4 [revised 2018 Aug 23];7:1001. doi: 10.12688/f1000research.15256.2.

Memon AR. Predatory journals spamming for publications: what should researchers do?
Sci Eng Ethics. 2018;24(5):1617-1639

Mercier E, et al. Invitations received from potential predatory publishers and fraudulent conferences: a 12-month early-career researcher experience.
Postgrad Med J. 2018;94(1108):104-108.

Richtig G, et al. Knowledge and influence of predatory journals in dermatology: A Pan-Austrian Survey.
Acta Derm Venereol. 2018;99(1):58-62. doi: 10.2340/00015555-3037.

Baum E. Beware the imposter: predatory conferences lure the unsuspecting. The MAP Newsletter: News and Trends. September 28, 2017.
The International Society for Medical Publication Professionals Web site.

Cress PE. Are predatory conferences the dark side of the open access movement?
Aesthet Surg J. 2017;37(6):734-738. doi: 10.1093/asj/sjw247.

Hunziker R. Avoiding predatory publishers in the post-Beall world: tips for writers and editors.
AMWA Journal. 2017;32(3):113-115.

Moher D, et al. Stop this waste of people, animals and money.
Nature. 2017;549(7670):23-25. doi: 10.1038/549023a .

Pearson GS. Avoiding predatory journals with “Think. Check. Submit.”
J Am Psychiatr Nurses Assoc. 2017;23(4):239-240. doi: 10.1177/1078390317716883.

Publication Best Practices

Derraik JGB, et al. Publishing without perishing: A guide to the successful reporting of clinical data.
Int J Low Extrem Wounds. 2019;18(3):219-227. doi: 10.1177/1534734619865860.

Foster C, et al. Good Practice for Conference Abstracts and Presentations: GPCAP.
Res Integr Peer Rev. 2019;4:11. doi: 10.1186/s41073-019-0070-x. eCollection 2019

Hesp BR, et al. A guide to applying the Good Publication Practice 3 guidelines in the Asia-Pacific region.
Res Integr Peer Rev. 2019;4:21. doi: 10.1186/s41073-019-0079-1

Hrynaszkiewicz I, et al. Publishers’ responsibilities in promoting data quality and reproducibility.
Handb Exp Pharmacol. 2019. doi: 10.1007/164_2019_290.

Ross-Hellauer T, et al. Guidelines for open peer review implementation.
Res Integr Peer Rev. 2019;4:4. doi: 10.1186/s41073-019-0063-9. eCollection 2019.

Bush LW, et al. Professional responsibilities regarding the provision, publication and dissemination of patient phenotypes in the context of clinical genetic and genomic testing: Points to consider—A statement of the American College of Medical Genetics and Genomics (ACMG).
Genet Med. 2018;20(2):169-171. doi: 10.1038/gim.2017.242.

DeTora L, et al. “Publication Ethics from the ground up.”
Int J Clin Pract. 2018;72(2).

McNutt MK, et al. “Transparency in authors’ contributions and responsibilities to promote integrity in scientific publication.”
Proc Natl Acad Sci U S A. 2018;115(11):2557-2560.

Schmidt B, et al. Ten considerations for open peer review.
F1000Res. 2018;7:969. doi: 10.12688/f1000research.15334.1.

Stocks A, et al. Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications.
Curr Med Res Opin. 2018;34(6):1163-1168. doi: 10.1080/03007995.2018.1451832.

Wallach JD, et al. Reproducible research practices, transparency, and open access data in the biomedical literature, 2015-2017.
Plos Biol. 2018;16(11):e2006930. doi: 10.1371/journal.pbio.2006930.

Mills I, et al. Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals.
F1000Res. 2017 Aug 16 [revised 2017 Sep 14];6:1489.

Battisti WP, et al. “Good publication practice for communicating company-sponsored medical research: GPP3.”
Ann Intern Med. 2015;163(6):461-464.

Scott-Lichter D and the Editorial Policy Committee, Council of Science Editors.
“CSE’s White Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update.” 3rd Revised Edition. Wheat Ridge, CO: 2012.

Consolidated Standards of Reporting Trials (CONSORT). “The CONSORT Flow Diagram.”
CONSORT website.

International Committee of Medical Journal Editors (ICMJE). “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.”
ICMJE website.

Data Reporting

Kallogjeri D, et al. Use of confidence intervals to improve the quality of research results reporting and interpretation.
JAMA Otolaryngol Head Neck Surg. 2019;145(6):491-493. doi: 10.1001/jamaoto.2019.0793.

Nguyen TV, et al. New guidelines for data reporting and statistical analysis: helping authors with transparency and rigor in research.
J Bone Miner Res. 2019;34(11):1981-1984.

Camps IF, et al. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.
Br J Clin Pharmacol. 2018;84(6):1384-1388. doi: 10.1111/bcp.13555.

Goldacre B, et al. Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource.
BMJ. 2018;362:k3218. doi: 10.1136/bmj.k3218.

Jurić D, et al. Clinical trials on drug-drug interactions registered in reported incongruent safety data in published articles: an observational study.
J Clin Epidemiol. 2018;104:35-45. doi: 10.1016/j.jclinepi.2018.07.017.

Hoffmann TC, et al. “Enhancing the usability of systematic reviews by improving the consideration and description of interventions.”
BMJ. 2017;358:j2998.

Saito H, Gill CJ. “How frequently do the results from completed US clinical trials enter the public domain? - A statistical analysis of the database.”
PLoS One. 2014;9(7):e101826.

Dwan K, et al. Reporting Bias Group. “Systematic review of the empirical evidence of study publication bias and outcome reporting bias — an updated review.”
PLoS One. 2013;8(7):e66844.

Jones CW, et al. “Non-publication of large randomized clinical trials: cross sectional analysis.”
BMJ. 2013;347:f6104.

Transparency in Industry-Sponsored Research

Borysowski J, et al. Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials.
Br J Clin Pharmacol. 2020;1-8. doi: 10.1111/bcp.14223.

Song SY, et al. The clinical trial transparency in oncology significantly increased over the recent years.
J Clin Epidemiol. 2020;119:100-108. doi: 10.1016/j.jclinepi.2019.11.018.

Baronikova S, et al. Commitments by the biopharmaceutical industry to clinical trial transparency: The evolving environment.
BMJ Evid Based Med. 2019. doi: 10.1136/bmjebm-2018-111145.

Humphreys BL. New requirements for clinical trial transparency provide new opportunities for informatics research.
J Am Med Inform Assoc. 2019;26(6):493-494. doi: 10.1093/jamia/ocz047.

DeVito NJ, et al. Noncommercial funders’ policies on trial registration, access to summary results, and individual patient data availability.
JAMA. 2018;319(16):1721-1723.

Gopal AD, et al. Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals.
Trials. 2018;19:448. doi: 10.1186/s13063-018-2825-y.

Evoniuk G, et al. “Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.”
BMJ. 2017;357:j1726.

Lassman SM, et al. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.
BMJ Open. 2017 Sep 23;7(9):e015110. doi: 10.1136/bmjopen-2016-015110.

Lee CJ, Moher D. “Promote scientific integrity via journal peer review data.”
Science. 2017;357(6348):256-257.

Iliff SA, Savastano G. “Naked transparency in communication.”
Lab Anim (NY). 2016;45(4):138.

Mooney LA, Fay L. “Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history.”
BMJ Open. 2016;6(7):e012362.

Weigel A. “Medical literature has seen a positive evolution of transparency.”
BMJ. 2016;354:i5043.

DeTora L, et al. “Publication planning: promoting an ethics of transparency and integrity in biomedical research.”
Int J Clin Pract. 2015;69(9):915-921.

Miller JE, et al. “Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012.”
BMJ Open. 2015;5(11):e009758.

Pignatti F, et al. “Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions.”
Clin Pharmacol Ther. 2015;98(5):522-533.

Alemayehu D, et al. “Perspectives on clinical trial data transparency and disclosure.”
Contemp Clin Trials. 2014;39(1):28-33.

Altman DG, Moher D. “Declaration of transparency for each research article.”
BMJ. 2013;347:f4796.

Data Sharing

Bauer PC, et al. Trust and cooperative behavior: Evidence from the realm of data-sharing.
PLoS One. 2019;14(8):e0220115. doi: 10.1371/journal.pone.0220115. eCollection 2019.

Kerr D, et al. The Oncology Data Network (ODN): A collaborative European data-sharing platform to inform cancer care.
Oncologist. 2019. pii: theoncologist.2019-0337. doi: 10.1634/theoncologist.2019-0337.

Milne R, et al. Trust in genomic data sharing among members of the general public in the UK, USA, Canada and Australia.
Hum Genet. 2019;138(11-12):1237-1246. doi: 10.1007/s00439-019-02062-0.

Resnik DB, et al. Effect of impact factor and discipline on journal data sharing policies.
Account Res. 2019;1-18. doi: 10.1080/08989621.2019.1591277.

Yin PT, et al. Sharing historical trial data to accelerate clinical development.
Clin Pharmacol Ther. 2019. doi: 10.1002/cpt.1608.

Boué S, et al. Embracing transparency through data sharing.
Int J Toxicol. 2018 Oct 3:1091581818803880. doi: 10.1177/1091581818803880. [Epub ahead of print].

Hopkins AM, et al. Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability.
BMC Med. 2018;16(1):165. doi: 10.1186/s12916-018-1154-z.

Martone ME, et al. “Data sharing in psychology.”
Am Psychol. 2018;73(2):111-125.

Park Y, et al. A parasite's perspective on data sharing.
Gigascience. 2018;7(11). doi: 10.1093/gigascience/giy129.

Polanin JR, Terzian M. A data-sharing agreement helps to increase researchers’ willingness to share primary data: Results from a randomized controlled trial.
J Clin Epidemiol. 2018 Oct 18. pii: S0895-4356(17)31330-6. doi: 10.1016/j.jclinepi.2018.10.006. [Epub ahead of print].

Ross JS, et al. Overview and experience of the YODA Project with clinical trial data sharing after 5 years.
Sci Data. 2018;5:180268. doi: 10.1038/sdata.2018.268.

Schmidt H, et al. An industry experience with data sharing.
N Engl J Med. 2018;379(21):2081-2082. doi: 10.1056/NEJMc1805610.

Bierer B, et al. “Data authorship as an incentive to data sharing.”
N Engl J Med. 2017;376(17):1684-1687.

Goldacre B, et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ. 2017;358: j3334. doi: 10.1136/bmj.j3334.

Taichman DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors.
N Engl J Med. 2017;376(23):2277-2279. doi: 10.1056/NEJMe1705439.

*Published simultaneously in BMJ, PLoS Med, Ann Intern Med, JAMA, Lancet, N Z Med J, Bull World Health Organ, Natl Med J India, J Korean Med Sci.

Hollis S, et al. “Best practice for analysis of shared clinical trial data.”
BMC Med Res Methodol. 2016;16(suppl 1):76.

International Committee of Medical Journal Editors (ICMJE). “Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors.”
Ann Intern Med. 2016;164(7):505-506.

Krumholz HM, Waldstreicher J. “The Yale Open Data Access (YODA) project — a mechanism for data sharing.”
N Engl J Med. 2016;375(5):403-405.

Manamley N, et al. “Data sharing and the evolving role of statisticians.”
BMC Med Res Methodol. 2016;16(suppl 1):75.

Mospan GA, Wargo KA. “Researchers’ experience with clinical data sharing.”
J Am Board Fam Med. 2016;29(6):805-807.

Tucker K, et al. “Protecting patient privacy when sharing patient-level data from clinical trial.”
BMC Med Res Methodol. 2016;16(suppl 1):77.

Hughes S, et al. “Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach.”
Pharm Stat. 2014;13(3):179-183.

Fletcher C. “European Federation of Statisticians in the Pharmaceutical Industry’s position on access to clinical trial data.”
Pharm Stat. 2013;12(6):333-336.

Nisen P, Rockhold F. “Access to patient-level data from GlaxoSmithKline clinical trials.”
N Engl J Med. 2013;369(5):475-478.

Disclosures/Conflicts of Interest

Grundy Q, et al. Conflict of interest as ethical shorthand: understanding the range and nature of "non-financial conflict of interest" in biomedicine.
J Clin Epidemiol. 2020;120:1-7. doi: 10.1016/j.jclinepi.2019.12.014.

Smith EJ, et al. European Association of Urology Guidelines Office: How we ensure transparent conflict of interest disclosure and management.
Eur Urol. 2020. doi: 10.1016/j.eururo.2020.01.010.

Bhar RH, et al. Conflict of interest in systematic reviews and its implications for public health policy.
Indian J Med Ethics. 2019;4(4):288-293. doi: 10.20529/IJME.2019.058.

DeTora LM, et al. Disclosures and conflicts of interest: Solving the riddle, wrapped in a mystery, inside an enigma.
Clin Ther. 2019. pii: S0149-2918(19)30394-7. doi: 10.1016/j.clinthera.2019.07.020.

Komesaroff PA, et al. Conflicts of interest: new thinking, new processes.
Intern Med J. 2019;49(5):574-577. doi: 10.1111/imj.14233.

Qaseem A, et al. Disclosure of interests and management of conflicts of interest in clinical guidelines and guidance statements: Methods from the clinical guidelines committee of the American College of Physicians.
Ann Intern Med. 2019;171(5):354-361. doi: 10.7326/M18-3279.

Teixeira da Silva JA, et al. Editors should declare conflicts of interest.
J Bioeth Inq. 2019;16(2):279-298. doi: 10.1007/s11673-019-09908-2.

Bauchner H, et al. Conflicts of interests, authors, and journals: New challenges for a persistent problem.
JAMA. 2018;320(22):2315-2318. doi: 10.1001/jama.2018.17593.

The May 2, 2017, issue of JAMA (volume 317, number 17, pages 1707-1812) is dedicated to conflicts of interest viewpoints and research articles. Several are highlighted below.

Mandrioli D, et al. Relationship between research outcomes and risk of bias, study sponsorship, and author financial conflicts of interest in reviews of the effects of artificially sweetened beverages on weight outcomes: a systematic review of reviews.
PLoS One. 2016;11(9):e0162198. doi: 10.1371/journal.pone.0162198.

Cappola AR, FitzGerald GA. “Confluence, not conflict of interest. Name change necessary.”
JAMA. 2015;314(17):1791-1792.

Lockhart AC, et al. “Physician and stakeholder perceptions of conflict of interest policies in oncology.”
J Clin Oncol. 2013;31(13):1677-1682.

International Committee of Medical Journal Editors (ICMJE). “ICMJE Form for Disclosure of Potential Conflicts of Interest.”
ICMJE website.

International Committee of Medical Journal Editors (ICMJE). “Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals.”
ICMJE website.

Pharmaceutical Research and Manufacturers of America (PhRMA). “PhRMA principles on conduct of clinical trials.” PhRMA website.

Sunshine Act

Rhee TG, et al. Impact of US industry payment disclosure laws on payments to surgeons: a natural experiment.
Res Integr Peer Rev. 2020;5(1). doi: 10.1186/s41073-019-0087-1.

Glass HE. Open payments and the US clinical landscape.
Ther Innov Regul Sci. 2019. doi: 10.1177/2168479019837526.

Kanter GP, et al. Evaluating open payments.
JAMA. 2019. doi: 10.1001/jama.2019.8171.

Toroser D, et al. “Systematic review of reports describing potential impact of the Sunshine Act on peer-reviewed medical publications.”
Curr Med Res Opin. 2016;32(3):547-553.

Toroser D, Pepitone K. “Two years into the Sunshine Act: synopsis of opportunities, challenges, learnings, and potential implications.”
Curr Med Res Opin. 2016;32(11):1899-1902.


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