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Items: 1 to 20 of 28


Promoting public access to clinical trial protocols: challenges and recommendations.

Chan AW, Hróbjartsson A.

Trials. 2018 Feb 17;19(1):116. doi: 10.1186/s13063-018-2510-1.


Toward a Tiered Model to Share Clinical Trial Data and Samples in Precision Oncology.

Broes S, Lacombe D, Verlinden M, Huys I.

Front Med (Lausanne). 2018 Jan 29;5:6. doi: 10.3389/fmed.2018.00006. eCollection 2018.


Publication ethics from the ground up.

DeTora L, Foster C, Nori M, Simcoe D, Skobe C, Toroser D.

Int J Clin Pract. 2018 Feb;72(2). doi: 10.1111/ijcp.13063. Epub 2018 Feb 8.


Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.

Giannuzzi V, Landi A, Bosone E, Giannuzzi F, Nicotri S, Torrent-Farnell J, Bonifazi F, Felisi M, Bonifazi D, Ceci A.

BMJ Open. 2017 Sep 11;7(9):e017358. doi: 10.1136/bmjopen-2017-017358.


Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to

So D, Knoppers BM.

PLoS One. 2017 Sep 8;12(9):e0184491. doi: 10.1371/journal.pone.0184491. eCollection 2017.


Clinical trial registries: more international, converging efforts are needed.

Pansieri C, Pandolfini C, Bonati M.

Trials. 2017 Feb 27;18(1):86. doi: 10.1186/s13063-017-1836-4.


IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity.

Krleža-Jerić K, Gabelica M, Banzi R, Martinić MK, Pulido B, Mahmić-Kaknjo M, Reveiz L, Šimić J, Utrobičić A, Hrgović I.

Biochem Med (Zagreb). 2016 Oct 15;26(3):308-307. Review.


Best practice for analysis of shared clinical trial data.

Hollis S, Fletcher C, Lynn F, Urban HJ, Branson J, Burger HU, Tudur Smith C, Sydes MR, Gerlinger C.

BMC Med Res Methodol. 2016 Jul 8;16 Suppl 1:76. doi: 10.1186/s12874-016-0170-y.


Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS).

Zarin DA, Tse T.

PLoS Med. 2016 Jan 19;13(1):e1001946. doi: 10.1371/journal.pmed.1001946. eCollection 2016 Jan. Review. No abstract available.


Sharing data from MS clinical trials: Opportunities, challenges, and future directions.

Coetzee T.

Mult Scler. 2015 Oct;21(11):1365-8. doi: 10.1177/1352458515608005.


Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial.

Panagiotou OA, Befano BL, Gonzalez P, Rodríguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators).

BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.


Semantic enrichment of longitudinal clinical study data using the CDISC standards and the semantic statistics vocabularies.

Leroux H, Lefort L.

J Biomed Semantics. 2015 Apr 9;6:16. doi: 10.1186/s13326-015-0012-6. eCollection 2015.


Anonymising and sharing individual patient data.

El Emam K, Rodgers S, Malin B.

BMJ. 2015 Mar 20;350:h1139. doi: 10.1136/bmj.h1139. No abstract available.


The use of surrogate endpoints in regulating medicines for cardio-renal disease: opinions of stakeholders.

Schievink B, Lambers Heerspink H, Leufkens H, De Zeeuw D, Hoekman J.

PLoS One. 2014 Sep 30;9(9):e108722. doi: 10.1371/journal.pone.0108722. eCollection 2014.


Sharing clinical trial data on patient level: opportunities and challenges.

Koenig F, Slattery J, Groves T, Lang T, Benjamini Y, Day S, Bauer P, Posch M.

Biom J. 2015 Jan;57(1):8-26. doi: 10.1002/bimj.201300283. Epub 2014 Jun 18. Review.


Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository.

Tudur Smith C, Dwan K, Altman DG, Clarke M, Riley R, Williamson PR.

PLoS One. 2014 May 29;9(5):e97886. doi: 10.1371/journal.pone.0097886. eCollection 2014.


Effects of erythropoiesis-stimulating agents on fatigue- and anaemia-related symptoms in cancer patients: systematic review and meta-analyses of published and unpublished data.

Bohlius J, Tonia T, Nüesch E, Jüni P, Fey MF, Egger M, Bernhard J.

Br J Cancer. 2014 Jul 8;111(1):33-45. doi: 10.1038/bjc.2014.171. Epub 2014 Apr 17. Review.


Increasing value and reducing waste: addressing inaccessible research.

Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HB.

Lancet. 2014 Jan 18;383(9913):257-66. doi: 10.1016/S0140-6736(13)62296-5. Epub 2014 Jan 8.


The Ontology of Clinical Research (OCRe): an informatics foundation for the science of clinical research.

Sim I, Tu SW, Carini S, Lehmann HP, Pollock BH, Peleg M, Wittkowski KM.

J Biomed Inform. 2014 Dec;52:78-91. doi: 10.1016/j.jbi.2013.11.002. Epub 2013 Nov 13.

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