منابع مشابه
Registration of clinical trials--a regional perspective.
The birth of the scientific clinical trial is often cited as an experiment by James Lind. On 20 May 1743, Lind compared the effect of a few supposed nutritional remedies against scurvy. The research subjects, 12 sailors suffering from scurvy on board the ship HMS Salisbury, were divided into 6 groups. In one group, each patient was given 2 oranges and 1 lemon every day, to eat upon an empty sto...
متن کاملChallenges from Variation across Regions in Cost Effectiveness Analysis in Multi-Regional Clinical Trials
Economic evaluation in the form of cost-effectiveness analysis has become a popular means to inform decisions in healthcare. With multi-regional clinical trials in a global development program becoming a new venue for drug efficacy testing in recent decades, questions in methods for cost-effectiveness analysis in the multi-regional clinical trials setting also emerge. This paper addresses some ...
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 کاملBayesian Modeling and Prediction of Patient Accrual in Multi-Regional Clinical Trials
SUMMARY With advances in medical research, effective treatments are becoming standard of care for many diseases. Consequently, when testing a new treatment, the sample size in a clinical trial is on the rise in order to demonstrate a moderate, yet clinically meaningful, improvement in therapeutic effect (compared to an active control), which often makes it impossible to enroll all patients from...
متن کاملRegional pathologies and globalization of clinical trials: has the time for regional trials arrived?
Trials: Has the Time for Regional Trials Arrived? To the Editor: We read with great interest the series of articles written by Drs Califf and DeMets1,2 regarding the lessons learned from cardiovascular clinical trials performed during last 2 decades. Indisputable evidence obtained from several large clinical trials conducted mostly in white populations with chronic heart failure (CHF) clearly d...
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ژورنال
عنوان ژورنال: Folia Pharmacologica Japonica
سال: 2012
ISSN: 0015-5691,1347-8397
DOI: 10.1254/fpj.139.22