scholarly journals The importance of Good Clinical Practice guidelines and its role in clinical trials

2008 ◽  
Vol 4 (1) ◽  
Author(s):  
A Vijayananthan ◽  
O Nawawi
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Good Clinical Practice

scholarly journals Good Clinical Trials by removing defensive interpretation of Good Clinical Practice guidelines

2021 ◽  
Author(s):  
Jonas M. Heijer ◽  
Jules A. A. C. Heuberger ◽  
Hemme Hijma ◽  
Annelieke C. Kruithof ◽  
Jeroen Smeden ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Good Clinical Practice

Primary Stroke Prevention in Nonvalvular Atrial Fibrillation: Implementing the Clinical Trial Findings

1997 ◽  
Vol 31 (10) ◽  
pp. 1187-1196 ◽  
Author(s):  
Patricia A Howard ◽  
Pamela W Duncan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Cost Effectiveness ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Randomized Clinical Trials ◽  
Nonvalvular Atrial Fibrillation ◽  
Risk Patients

OBJECTIVE: To review the clinical trials evaluating warfarin for primary stroke prophylaxis in nonvalvular atrial fibrillation (NVAF), to discuss the relative benefits and risks of warfarin versus aspirin therapy, and to review the clinical practice guidelines and identify potential barriers to their implementation in clinical practice. DATA SOURCES: A MEDLINE literature search was performed to identify clinical trials of antithrombotic therapy for NVAF, clinical practice guidelines, studies evaluating physician practices and attitudes, cost-effectiveness studies, and pertinent review articles. Key search terms included atrial fibrillation, stroke, antithrombotic, warfarin, aspirin, and cost-effectiveness. DATA EXTRACTION: Prospective, randomized clinical trials were selected for analysis. Clinical practice guidelines from recognized panels of experts were reviewed. Comprehensive review articles were selected. DATA SYNTHESIS: NVAF is a common arrhythmia that is associated with a substantial risk for stroke. Seven prospective, randomized, clinical trials have conclusively demonstrated the efficacy of warfarin for stroke prevention. The greatest benefits are achieved in older patients and those with comorbidities that increase their risk for stroke. The potential benefits of preventing a devastating stroke, however, must be weighed against the potential for bleeding complications. Warfarin has been shown to be cost-effective in high-risk patients, provided the rate of complications is minimized. Nonetheless, many physicians remain hesitant to implement warfarin therapy in older, high-risk patients. The clinical data on aspirin are less consistent than those observed with warfarin. Aspirin appears to be most effective in younger individuals or those considered to be at low risk for stroke. CONCLUSIONS: In patients with NVAF, the personal, social, and economic consequences of stroke are often devastating. Clinical trials have provided definitive proof that the risks of stroke can be significantly reduced through the use of appropriate antithrombotic therapy. Despite this evidence and the recommendations of a number of clinical practice guidelines, variations in care exist that continue to place patients at risk. Additional outcomes research is needed to evaluate the impact of the clinical trial findings and practice guidelines on clinical practice and to develop methods for overcoming barriers to implementation.

Book review: Deadly medicines and organized crime

2016 ◽  
Vol 2 (2) ◽  
pp. 138-139
Author(s):  
Shankar PR ◽  
Alshakka MAM
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Pharmaceutical Industry ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Organized Crime ◽  
Healthcare Professionals ◽  
Meta Analysis ◽  
Degree Of Control

Clinical trials have attracted negative attention recently. The degree of control of the pharmaceutical industry over the design, conduct and analysis of clinical trials has been criticized. Healthcare professionals increasingly rely on data obtained from clinical trials and from meta-analysis and systematic reviews. The process of publishing clinical trials and framing clinical practice guidelines is being increasingly influenced by the pharmaceutical industry.

Good Clinical Practice: Guidelines and Requirements

2020 ◽  
pp. 117-129
Author(s):  
Najmeh Foroughi-Heravani ◽  
Mahdieh Hadavandkhani ◽  
Babak Arjmand ◽  
Moloud Payab ◽  
Fakher Rahim ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Good Clinical Practice
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