منابع مشابه
Monitoring clinical trials.
Editor—Lilford et al make a case that interim analyses from randomised trials should be shared with participants and doctors and patients. These analyses should be shared for the sake of freedom of information and properly informed consent, as a counterweight to paternalism, for the better public understanding of uncertainty, and regardless of drug regulatory or financial considerations. But th...
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Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. A...
متن کاملElectrophysiological Monitoring in Clinical Trials
Electrophysiological testing remains an important efficacy parameter in clinical neuropathy trials. The quality of nerve conduction studies in reported trials varies greatly, and may be responsible for negative results. We report the utilization of an expert core lab for electrophysiological testing. With the core lab, the variability of repeat testing is comparable to that of a single, excelle...
متن کاملEvaluation of Clinical Trials
In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...
متن کاملEvidence Based Medicine: Clinical Trials
Evidence based medicine is very important for success of modern medicine. It is the ongoing process of using the most reliable evidence from clinical studies, scientific understanding and medical practice to make the best possible medical choice for patients. Evidence based medicine is how medicine advances and how we get improvements in life expectancy and quality of life. It not only identifi...
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ژورنال
عنوان ژورنال: BMJ
سال: 2001
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.323.7326.1424