Large streamlined trials in cardiovascular disease

European Heart Journal

Volumn 35, Issue 9, 2014, Pages 544-548

  Calvo, Gonzalo ^a   McMurray, John J V ^b   Granger, Christopher B ^c   Alonso García, Ángeles ^d   Armstrong, Paul ^e   Flather, Marcus ^f   Gómez Outes, Antonio ^g   Pocock, Stuart ^h   Stockbridge, Norman ⁱ   Svensson, Anders ^j   Van De Werf, Frans ^k  

^a INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^d ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^e UNIVERSITY OF ALBERTA   (Canada)

^f UNIVERSITY OF EAST ANGLIA   (United Kingdom)

^g Parque Empresarial Las Mercedes   (Spain)

^h LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j F HOFFMANN LA ROCHE LTD   (Switzerland)

^k UNIVERSITY OF LEUVEN   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); COST; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; GOOD CLINICAL PRACTICE; HEALTH CARE COST; HIGH RISK PATIENT; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; JOINT VENTURE; METHODOLOGY; NOTE; OUTCOME ASSESSMENT; PATIENT EDUCATION; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RANDOM ERROR; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK MANAGEMENT; ROOT CAUSE ANALYSIS; SCREENING TEST; STUDY DESIGN; SYSTEMATIC ERROR;

CARDIOVASCULAR DISEASES; COSTS AND COST ANALYSIS; DATA COLLECTION; FOLLOW-UP STUDIES; HUMANS; PROFESSIONAL PRACTICE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84895890912     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/eht535     Document Type: Note

References (19)

1. Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 2006;3:496-502.
2. Eisenstein EL, Podesta O, Reid ED, Sandercock P, Shakhov P, Terrin ML, Sellers MA, Califf RM, Granger CB, Diaz R. Sensible approaches for reducing clinical trial costs. 2008;5:75-84.
3. Yusuf S, Bosch J, Devereaux PJ, Collins R, Baigent C, Granger C, Califf R, Temple R Sensible guidelines for the conduct of large randomized trials. Clin Trials 2008;5: 38-39.
4. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012;307: 1838-1847.
5. EMA. Guideline on Clinical Investigation of Medicinal Products for the Treatment of Acute Heart Failure (draft). http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2012/10/WC500133497.pdf (22 July 2013).
6. EMA. Guideline on Clinical Investigation of Medicinal Products for Prevention of Stroke and Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2012/08/WC500130941.pdf (22 July 2013).
7. Pocock SJ, Ariti CA, Collier TJ,Wang D. The win ratio: anewapproach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J 2012; 33:176-182.
8. Bakal JA, Westerhout CM, Cantor WJ, Fernandez-Aviles F, Welsh RC, Fitchett D, Goodman SH,ArmstrongPW. Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint. Eur Heart J 2013;34:903-908.
9. Anker SD, McMurray JJV. Time to move on from 'time-to-first': should all events be included in the analysis of clinical trials? Eur Heart J 2012;33:2764-2765.
10. Pogue J,Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials 2009;6:239-251.
11. Alexander JH, Levy E, Lawrence J, Hanna M, Waclawski AP, Wang J, Califf RM, Wallentin L, Granger CB. Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. Am Heart J 2013;166:559-565.e1.
12. EMA. Reflection Paper on Risk-based Quality Management in Clinical Trials. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2011/08/WC500110059.pdf (9 July 2013).
13. FDA. Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring (Draft Aug 2011). http://www.fda.gov/ downloads/Drugs/.../Guidances/UCM269919.pdf (9 July 2013).
14. Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, VerheugtFW, Gibson CM. Rivaroxaban in patients with a recent acute coronary syndrome. NEJM 2012;366:9-19.
15. FDA Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for Xareltow (Rivaroxaban) Oral Tablets; 2012. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM304755.pdf#page= 192 (9 July 2013).
16. ICH Topic E 6 (R1). Good Clinical Practice: Consolidated Guidance. http://www.ich. org/products/guidelines/efficacy/efficacy-single/article/good- clinical-practice. html (9 July 2013).
17. Clinical Trials Transformation Initiative. http://www. trialstransformation.org (17 September 2013).
18. Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC. http://ec. europa.eu/health/files/clinicaltrials/2012-07/proposal/ 2012-07-proposal-en.pdf.
19. HemminkiA, Kellokumpu-Lehtinen PL. Harmful impact of EU clinical trials directive. BMJ 2006;332:501-502.