Links
Digital Productivity
- Merlin Mann
- Mann's "Inbox Zero" Video
- Black Belt Productivity
- Matthew Cornell
- Lifehacker.com
- Lifehack.org
- David Seah
- Ruthless Email
- Mike St. Pierre
Organizations
Conferences
Info & Opinion
May 9, 2008
Nudging By FDA
FDA-Ready Graphs From Insightful
Inspired by Web 2.0 tools that foster sharing and collaboration, Insightful Software released new software to generate charts and graphs in a regulated setting.
Report Blames FDA
GAO: Elderly Trial Data Lacking
The GAO says the FDA and sponsors aren’t doing enough to analyze clinical trial data about the elderly.
Guidance On Schedule
FDA’s Wilson On Adaptive Paths
A prominent official talks about how to approach the regulatory aspects of adaptive designs.
Strategies from Pfizer & Pacific Bridge
RAPS 2007: Going To India & China
At the recent annual meeting for regulatory affairs professionals, there were two presentations on the right attitude for China and Brazil.
‘Enough--This Is The Label’
RAPS: CDER’s Kweder, Part II
Reading between the lines of a presentation by Sandra Kweder of FDA-CDER. How industry may have to adapt to an evolving review process at the agency.
For the all the excitement and anticipation around adaptive designs for clinical trials, there’s always been one pesky fly in the ointment. Do regulators actually bless adaptive approaches when sponsors propose them? Has hype inflated expectations for such a promising technique? Adaptive trials—which include a statistical regimen to use the… more...
Paying lip service to the woes of the investigative site is a time-honored hobby in the world of clinical trials. Doing something to really help the site? Rare. Boston patient diary company PHT is trying to change that. It has revamped its electronic patient-reported outcome (ePRO) software to run on… more...
From hundreds to thousands of pages, the trial master file (TMF) contains every last bit of data associated with a trial including, under Good Clinical Practice (GCP), the signatures of all the investigators. Many key pieces of the electronic common technical document (eCTD) are drawn from the TMF. Surprisingly, there… more...
It’s been coming for a long time. Now it’s here. The FDA and the pharmaceutical industry adopt new processes imperceptibly. Deliberately. But as the new year begins, 2008 has at least one stark shift. As of now, electronic regulatory submissions to the U.S. authorities must use the electronic common technical… more...
How fast can your company analyze its clinical data? If a medical journal says your data are incomplete on a Thursday morning, is the turnaround time for your response a) one month b) six months or c) “it depends”? In an era of withering scrutiny of clinical research, biostatisticians are… more...
Data about the elderly aren’t properly represented in clinical studies, and the aged may be at risk when they take prescription drugs. That was the upshot of Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials, a recent report by the Government Accountability… more...
Adaptive trials are very much on the minds of the clinical trial community, with a few big sponsors like Novartis and Merck plunging into the systems necessary to support them. Many other companies are wondering about just how much infrastructure (technologically) or process change (organizationally) will be necessary to implement… more...
