𝔖 Bobbio Scriptorium
✦   LIBER   ✦

EU Clinical trial regulation in the environment of rare diseases: time for a change

✍ Scribed by Martine Zimmermann

Book ID
120697015
Publisher
BioMed Central
Year
2010
Tongue
English
Weight
175 KB
Volume
5
Category
Article
ISSN
1750-1172

No coin nor oath required. For personal study only.

📜 SIMILAR VOLUMES

Interpreting the results of Parkinson's
Interpreting the results of Parkinson's disease clinical trials: Time for a change
✍ Nick H. G. Holford; John G. Nutt 📂 Article 📅 2011 🏛 John Wiley and Sons 🌐 English ⚖ 199 KB 👁 1 views

## Abstract Randomized clinical trials testing putative disease‐modifying agents in Parkinson's disease (PD) have yielded controversial results that have not influenced evidence‐based recommendations for the treatment of PD. We argue that the failure of these clinical trials may be linked to end po

Time for changes in the design, analysis
Time for changes in the design, analysis, and reporting of rheumatoid arthritis clinical trials
✍ David T. Felson; Jennifer J. Anderson; Robert F. Meenan 📂 Article 📅 1990 🏛 John Wiley and Sons 🌐 English ⚖ 910 KB

The randomized, controlled clinical trial has become the standard approach to evaluating the efficacy of slow-acting drugs in the treatment of rheumatoid arthritis (RA). Such trials, which were used as far back as the 1940s to evaluate antimalarial agents and gold and as recently as 1988 to evaluate

The ADAS-cog and clinically meaningful c
The ADAS-cog and clinically meaningful change in the VISTA clinical trial of galantamine for Alzheimer's disease
✍ Kenneth Rockwood; Sherri Fay; Mary Gorman 📂 Article 📅 2010 🏛 John Wiley and Sons 🌐 English ⚖ 184 KB 👁 2 views

## Abstract ## Background A minimum 4‐point change at 6 months on the Alzheimer's disease assessment scale‐cognitive subscale (ADAS‐cog) is deemed clinically important, but this cut‐point has been little studied in relation to clinical meaningfulness. In an investigator‐initiated, clinical trial o