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Tracking adverse events in RCTs: lack of agreement among regulatory institutions

- bmj.com [PDF] 
LM Santiago, SM Debanne, D Neuhauser - British Medical Journal, 2003 - qshc.bmj.com
Tracking adverse events in RCTs: lack of agreement among regulatory institutions
We need to do a better job of keeping track of potential side effects when
designing rand- omized clinical trials (RCTs). Consider an RCT for a new ...
Cited by 2 - Related articles - BL Direct - All 7 versions

Take Heart! A Guide to Coping with Cardiac Surgery for Patients and their Families


C Rayner - Quality and Safety in Health Care, 2003 - qshc.bmj.com
What patients? A statistician might complain that there is no evidence in these
pages of studies made by experts of carefully balanced statistically valid
groups (including control groups, of course), no elegantly designed charts ...
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[CITATION] American Thoracic Society. The ethical conduct of clinical research involving critically ill …


JM Luce, DJ Cook, TR Martin… - Am J Respir Crit Care Med, 2004
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Generic patient self-report and investigator report instruments of therapeutic safety and …


MND Lassere, KR Johnson, S Van Santen, K … - Journal of Rheumatology, 2005 - jrheum.org
ABSTRACT. A patient self-report instrument was designed as a patient event index
that maps to a parallel inves- tigator instrument. Event importance (a composite
of severity, frequency, and duration) was report- ed, but attribution was ...
Cited by 4 - Related articles - BL Direct - All 8 versions

Patient based method of assessing adverse events in clinical trials in rheumatology: the …

- stanford.edu [PDF] 
V Welch, G Singh, CV Strand, J Fries, M Boers … - Journal of rheumatology, 2001 - jrheum.org
From the Clinical Epidemiology Unit, Loeb Research Institute, Ottawa, Ontario,
Canada; Department of Medicine, Stanford University, Palo Alto, California, USA;
Department of Clinical Epidemiology, VU University Hospital, Amsterdam, The ...
Cited by 5 - Related articles - BL Direct - All 12 versions

Challenges and progress in adverse event ascertainment and reporting in clinical trials.


MND Lassere, KR Johnson, TG Woodworth, DE … - The Journal of Rheumatology, 2005 - jrheum.org
Toxicity, safety, and tolerability are integral facets of patient risk/benefit
decisions, yet the capacity to define, measure, and compare these aspects is
underdeveloped compared to aspects of efficacy. There are many reasons for ...
Cited by 5 - Related articles - BL Direct - All 7 versions

Swedish registers to address drug safety and clinical issues in Rheumatoid Arthritis


J Askling, M Fored, P Geborek, L Jacobsson, R … - British Medical Journal, 2006 - ard.bmj.com
Online First articles must include the digital object identifier (DOIs) and date
of initial publication. establish publication priority; they are indexed by
PubMed from initial publication. Citations to may be posted when available ...
Cited by 7 - Related articles - All 2 versions

[PDF] Bleeding during critical illness: a prospective cohort study using a new measurement tool


DM Arnold, L Donahoe, FJ Clarke, AJ Tkaczyk … - Clin Invest Med, 2007 - jps.library.utoronto.ca
1 Department of Medicine, McMaster University, Hamilton, Ontario, Canada 2
Canadian Blood Services, Hamilton, Ontario, Canada 3 Department of Clinical
Epidemiology and Biostatistics, McMaster University and St. Joseph's ...
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[CITATION] PROTECT Investigators; Canadian Critical Care Trials Group. Prophylaxis of …


DJ Cook, G Rocker, M Meade, GH Guyatt, W … - J Crit Care, 2005
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A critical appraisal of toxicity indexes in rheumatology.


PM Peloso, JG Wright, C Bombardier - The Journal of rheumatology, 1995 - ncbi.nlm.nih.gov
1: J Rheumatol. 1995 May;22(5):989-94. A critical appraisal of toxicity indexes
in rheumatology. Peloso PM, Wright JG, Bombardier C. ...
Cited by 8 - Related articles - BL Direct - All 2 versions


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