« Return to News | Clinical Intelligence

Bert Spilker's Pharma Principles of The Week

Friday, February 9, 2007 04:08 PM

Posted by: Bert Spilker

  • Avoid procedure bloat, which occurs when a clinical trial protocol is prepared by taking the previous one and adding some additional tests. This is fairly common as a drug passes through the development path.
  • As soon as patient enrollment decreases below projections by a fixed number determined in advance of the trial, seek to learn the cause. Determine if this is evident at all or only some sites (i.e., is it site-specific or protocol-specific).  Either adjust the protocol or change the recruitment strategy. Do not simply add sites until you determine that that is a reasonable action and is likely to address the problem.
  • Monitors must understand the intensity and latitude they are allowed in their monitoring activities. Sometimes it may only be necessary to monitor the high enrollers, or a random group of sites in large trials.  In mega-trials it is impossible and not regulatoraly required to monitor these trials as extensively as pivotal trials.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.