Non-publication is common among phase 1, single-center, not prospectively registered, or early terminated clinical drug trials

PLoS ONE

Volumn 11, Issue 12, 2016, Pages

  Van Den Bogert, Cornelis A ^a,b,c   Souverein, Patrick C ^a   Brekelmans, Cecile T M ^b   Janssen, Susan W J ^c   Koëter, Gerard H ^b   Leufkens, Hubert G M ^a   Bouter, Lex M ^d  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Central Committee on Research Involving Human Subjects (CCMO)   (Netherlands)

^c NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONTRACT RESEARCH ORGANIZATION; DRUG EFFECT; EARLY TERMINATION OF CLINICAL TRIAL; HUMAN; INSTITUTIONAL REVIEW BOARD; LEGAL ASPECT; MULTICENTER STUDY (TOPIC); NETHERLANDS; PEER REVIEW; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PROFESSIONAL STANDARD; PUBLICATION; PUBLICATION APPROVAL; REGISTRATION; ALGORITHM; BIBLIOMETRICS; DRUG APPROVAL; DRUG SCREENING; FOLLOW UP; KAPLAN MEIER METHOD; MULTIVARIATE ANALYSIS; ODDS RATIO; PUBLISHING; STATISTICS AND NUMERICAL DATA;

ALGORITHMS; BIBLIOMETRICS; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG APPROVAL; DRUG EVALUATION; ETHICS COMMITTEES, RESEARCH; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIER ESTIMATE; MULTIVARIATE ANALYSIS; NETHERLANDS; ODDS RATIO; PEER REVIEW; PUBLISHING;

EID: 85006007496     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0167709     Document Type: Article

References (52)

1. Chalmers I, Glasziou P (2009) Avoidable waste in the production and reporting of research evidence. Lancet 374: 86-89. doi: 10.1016/S0140-6736(09)60329-9 PMID: 19525005
2. Ioannidis JP (2014) Clinical trials: what a waste. BMJ 349: g7089. doi: 10.1136/bmj.g7089 PMID: 25499097
3. Bardy AH (1998) Bias in reporting clinical trials. British journal of clinical pharmacology 46: 147-150. doi: 10.1046/j.1365-2125.1998.00759.x PMID: 9723823
4. Simes RJ (1986) Publication bias: the case for an international registry of clinical trials. Journal of clinical oncology: official journal of the American Society of Clinical Oncology 4: 1529-1541.
5. Tam VC, Tannock IF, Massey C, Rauw J, Krzyzanowska MK (2011) Compendium of unpublished phase III trials in oncology: characteristics and impact on clinical practice. Journal of clinical oncology: official journal of the American Society of Clinical Oncology 29: 3133-3139.
6. Blumle A, Antes G, Schumacher M, Just H, von Elm E (2008) Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others. Journal of medical ethics 34: e20. doi: 10.1136/jme.2008.024521 PMID: 18757621
7. de Jong JP, Ter Riet G, Willems DL (2010) Two prognostic indicators of the publication rate of clinical studies were available during ethical review. J Clin Epidemiol 63: 1342-1350. doi: 10.1016/j.jclinepi. 2010.01.018 PMID: 20558034
8. Decullier E, Chan AW, Chapuis F (2009) Inadequate dissemination of phase I trials: a retrospective cohort study. PLoS medicine 6: e1000034. doi: 10.1371/journal.pmed.1000034 PMID: 19226185
9. Decullier E, Lheritier V, Chapuis F (2005) Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 331: 19. doi: 10.1136/bmj.38488.385995.8F PMID: 15967761
10. Dickersin K, Min YI, Meinert CL (1992) Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 267: 374-378. PMID: 1727960
11. Easterbrook PJ, Matthews DR (1992) Fate of research studies. Journal of the Royal Society of Medicine 85: 71-76. PMID: 1538384
12. Kasenda B, Schandelmaier S, Sun X, von Elm E, You J, et al. (2014) Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 349: g4539. doi: 10.1136/ bmj.g4539 PMID: 25030633
13. Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A, et al. (2003) Role of a research ethics committee in follow-up and publication of results. Lancet 361: 1015-1016. doi: 10.1016/S0140-6736(03)12799-7 PMID: 12660062
14. Stern JM, Simes RJ (1997) Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 315: 640-645. PMID: 9310565
15. Sune P, Sune JM, Montoro JB (2013) Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results. PLoS One 8: e54583. doi: 10.1371/journal. pone.0054583 PMID: 23382919
16. von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, et al. (2008) Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee. Swiss medical weekly 138: 197-203. PMID: 18389392
17. Massey PR, Wang R, Prasad V, Bates SE, Fojo T (2016) Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. The oncologist 21: 261-268. doi: 10. 1634/theoncologist.2015-0516 PMID: 26888691
18. Dwan K, Gamble C, Williamson PR, Kirkham JJ (2013) Systematic review of the empirical evidence of study publication bias and outcome reporting bias-an updated review. PloS one 8: e66844. doi: 10. 1371/journal.pone.0066844 PMID: 23861749
19. ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Update December 2015. http://www.icmje.org/icmje-recommendations.pdf Last accessed on 2 November 2016.
20. Moorthy VS, Karam G, Vannice KS, Kieny MP (2015) Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS medicine 12: e1001819. doi: 10.1371/journal.pmed.1001819 PMID: 25874642
21. Food and Drug Administration Amendments Act of 2007, Title VIII-Clinical trial databases. Public Law 110-85. September 27, 2007.
22. Amendment of the Medical Research Involving Human Subjects Act with regard to the evaluation of the act and recovery of incomplete implementation of guideline no. 2001/20/EG. Dossier 31452. Enacted as per 1 July 2012 (full text in Dutch only).
23. EFPIA EFPIA Position-Transparency of Information on Clinical Trials included in the Proposed EU Database (Article 78 of the Proposal for a Regulation on Clinical Trials). http://www.efpia.eu/uploads/ Modules/Documents/efpia-key-messages-transparency-final-10.12.2012-updated-0.pdf. Last accessed on 2 November 2016.
24. Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, et al. (2013) Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 347: f6104. doi: 10.1136/bmj.f6104 PMID: 24169943
25. Lampert A, Hoffmann GF, Ries M (2016) Ten Years after the International Committee of Medical Journal Editors' Clinical Trial Registration Initiative, One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis. PloS one 11: e0144973. doi: 10.1371/journal. pone.0144973 PMID: 26735955
26. Ramsey S, Scoggins J (2008) Commentary: practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. The oncologist 13: 925-929. doi: 10.1634/ theoncologist.2008-0133 PMID: 18794216
27. Shamliyan T, Kane RL (2012) Clinical research involving children: registration, completeness, and publication. Pediatrics 129: e1291-1300. doi: 10.1542/peds.2010-2847 PMID: 22529271
28. Song F, Parekh-Bhurke S, Hooper L, Loke YK, Ryder JJ, et al. (2009) Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies. BMC medical research methodology 9: 79. doi: 10.1186/1471-2288-9-79 PMID: 19941636
29. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR (1991) Publication bias in clinical research. Lancet 337: 867-872. PMID: 1672966
30. van den Bogert CA, Souverein PC, Brekelmans CT, Janssen SW, van Hunnik M, et al. (2015) Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study. BMJ open 5: e007827. doi: 10.1136/bmjopen-2015-007827 PMID: 26152325
31. ToetsingOnline. www.toetsingonline.nl. Last accessed on 5 August 2016.
32. http://www.ccmo.nl/en/accredited-mrecs Last accessed on 5 August 2016.
33. Food and Drug Administration. Code of Federal Regulations 21CFR312.21. Phases of an investigation. Title 21, Volume 5, Revised as of April 1, 2015.
34. Nurgat ZA, Craig W, Campbell NC, Bissett JD, Cassidy J, et al. (2005) Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. British journal of cancer 92: 1001-1005. doi: 10.1038/sj.bjc.6602423 PMID: 15770219
35. Hole OP, Nitter-Hauge S, Cederkvist HR, Winther FO (2009) An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results. European journal of clinical pharmacology 65: 315-318. doi: 10.1007/s00228-008-0601-8 PMID: 19104790
36. Mattila T, Stoyanova V, Elferink A, Gispen-de Wied C, de Boer A, et al. (2011) Insomnia medication: do published studies reflect the complete picture of efficacy and safety? European neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology 21: 500-507.
37. Kasenda B, von Elm E, You J, Blumle A, Tomonaga Y, et al. (2014) Prevalence, characteristics, and publication of discontinued randomized trials. JAMA 311: 1045-1051. doi: 10.1001/jama.2014.1361 PMID: 24618966
38. Moher D, Glasziou P, Chalmers I, Nasser M, Bossuyt PM, et al. (2015) Increasing value and reducing waste in biomedical research: who's listening? Lancet.
39. 2016 AChwanLaoA
40. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. European Commission. Offic J Eur Union 2014;158:1-76.
41. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG (2004) Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 291: 2457-2465. doi: 10.1001/jama.291.20.2457 PMID: 15161896
42. Hemminki E (1980) Study of information submitted by drug companies to licensing authorities. British medical journal 280: 833-836. PMID: 7370687
43. Hewitt CE, Mitchell N, Torgerson DJ (2008) Listen to the data when results are not significant. BMJ 336: 23-25. doi: 10.1136/bmj.39379.359560.AD PMID: 18174597
44. Stewart LA, Parmar MK (1996) Bias in the analysis and reporting of randomized controlled trials. International journal of technology assessment in health care 12: 264-275. PMID: 8707499
45. Law ignored, patients at risk. December 13, 2015. http://www.statnews.com/2015/12/13/clinical-trialsinvestigation/. Last accessed on 29 March 2016.
46. Chen R, Desai NR, Ross JS, Zhang W, Chau KH, et al. (2016) Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ 352: i637. doi: 10.1136/bmj. i637 PMID: 26888209
47. Van den Bogert CA, Cohen AF (2015) Need for a proactive and structured approach to risk analysis when designing phase I trials. BMJ 351: h3899. doi: 10.1136/bmj.h3899 PMID: 26201349
48. Royal Statistical Society statement on publication of the study-protocol BIA-102474-101 for the French "first-in-man" trial in healthy volunteers. http://www.rss.org.uk/Images/PDF/about/press-releases/2016-01-22-rss-statment-BIA-102474-101-french-first-trial-in-healthy-volunteers.pdf, 22 January 2016. Last accessed on 29 March 2016.
49. Salzberg M (2012) First-in-Human Phase 1 Studies in Oncology: The New Challenge for Investigative Sites. Rambam Maimonides medical journal 3: e0007. doi: 10.5041/RMMJ.1074 PMID: 23908831
50. Ioannidis JP, Greenland S, Hlatky MA, Khoury MJ, Macleod MR, et al. (2014) Increasing value and reducing waste in research design, conduct, and analysis. Lancet 383: 166-175. doi: 10.1016/S0140-6736(13)62227-8 PMID: 24411645
51. Dickersin K (1997) How important is publication bias? A synthesis of available data. AIDS education and prevention: official publication of the International Society for AIDS Education 9: 15-21.
52. Huser V, Cimino JJ (2013) Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration. Journal of the American Medical Informatics Association: JAMIA 20: e169-174. doi: 10.1136/amiajnl-2012-001501 PMID: 23396544