PMC61 MONITORING OF HEALTH ECONOMIC DATA IN CLINICAL TRIALS
โ Scribed by M Bharmal; S Viswanathan; E Gemmen
- Book ID
- 118614538
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 74 KB
- Volume
- 13
- Category
- Article
- ISSN
- 1098-3015
No coin nor oath required. For personal study only.
๐ SIMILAR VOLUMES
This article presents some real-life challenges faced by clinical trial Data Monitoring Committees (DMCs), with the aim of clarifying some of the controversial issues that relate to both statistical stopping boundaries and DMC decision-making. Specific attention is given to what constitutes a sensib
Many clinical trials organizations use regular interim analyses to monitor the accruing results in large clinical trials. In disease areas such as cancer, where survival is usually a major outcome variable, ethical considerations may lead to a stipulated requirement for data monitoring of mortality.
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecti