Registration of randomized clinical trials--a challenge.

作者: R. M. Østervig , A. Sonne , L. S. Rasmussen

DOI: 10.1111/AAS.12575

关键词: Trial registrationPediatricsMedicineDeclaration of HelsinkiClinical trialEmergency medicineRandomized controlled trial

摘要: Background Registration of interventional studies is necessary according to the Declaration Helsinki but implementation has been a challenge for many journals. Acta Anaesthesiologica Scandinavica (Acta) requires registration conducted after January 1st 2010. We aimed assess proportion correctly registered randomized controlled trials (RCTs) published in from 2009 2014. Methods We manually searched all issues 2014 RCTs. Information about timing data collection and trial registries was extracted. classified RCTs as when it could be verified that patient enrolment started registry. Results We identified 200 Dates were not specified 51 (25.5%). The increased significantly 17.1% (19/111) starting before 2010 63.2% (24/38, P < 0.01). Most clinical at clinicaltrials.gov. Conclusion Many adequately requirement resulted significant increase trials.

参考文章(10)
Catherine De Angelis, Jeffrey M Drazen, Frank A Frizelle, Charlotte Haug, John Hoey, Richard Horton, Sheldon Kotzin, Christine Laine, Ana Marusic, A John PM Overbeke, Torben V Schroeder, Hal C Sox, Martin B Van Der Weyden, Clinical trial registration: a statement from the International Committee of Medical Journal Editors The Lancet. ,vol. 364, pp. 911- 912 ,(2004) , 10.1016/S0140-6736(04)17034-7
Roderik F. Viergever, Ghassan Karam, Andreas Reis, Davina Ghersi, The Quality of Registration of Clinical Trials: Still a Problem PLoS ONE. ,vol. 9, pp. e84727- ,(2014) , 10.1371/JOURNAL.PONE.0084727
Daniël A Korevaar, Patrick M M Bossuyt, Lotty Hooft, Infrequent and incomplete registration of test accuracy studies: analysis of recent study reports BMJ Open. ,vol. 4, ,(2014) , 10.1136/BMJOPEN-2013-004596
An-Wen Chan, Jennifer M Tetzlaff, Douglas G Altman, Kay Dickersin, David Moher, SPIRIT 2013: new guidance for content of clinical trial protocols. The Lancet. ,vol. 381, pp. 91- 92 ,(2013) , 10.1016/S0140-6736(12)62160-6
Ayman El-Menyar, Ameer Aslam, Sameera Imanullah, Mohammad Asim, Registration of Clinical Trials: Is it Really Needed? North American Journal of Medical Sciences. ,vol. 5, pp. 713- 715 ,(2013) , 10.4103/1947-2714.123266
Christopher W Jones, Lara Handler, Karen E Crowell, Lukas G Keil, Mark A Weaver, Timothy F Platts-Mills, None, Non-publication of large randomized clinical trials: cross sectional analysis BMJ. ,vol. 347, ,(2013) , 10.1136/BMJ.F6104
Sándor Judit, Domján Andrea, Kakuk Péter, World Medical Association Declaration of Helsinki (WMA) - Ethical principles for medical research involving human subjects LAM (Lege Artis Medicinæ). ,vol. 24, pp. 133- 136 ,(2014)
D A Korevaar, P M M Bossuyt, N Molenaar, R J P M Scholten, L Hooft, Endorsement of ICMJE's Clinical Trial Registration Policy: a survey among journal editors. Netherlands Journal of Medicine. ,vol. 72, pp. 349- 355 ,(2014)
, Observational Studies: Getting Clear about Transparency PLoS Medicine. ,vol. 11, pp. e1001711- None ,(None) , 10.1371/JOURNAL.PMED.1001711