Subject Recruitment
The consumer press has its spotlight on clinical research again, and some commentators are focusing on subject recruitment.
European Regulatory Agencies
With 2003 fast approaching, all we know for sure about the EU?s legislative changes is that nothing is final yet.
Cross-over Trials in Clinical Research
The reviewer calls the second edition of Stephen Senn?s text ?well structured and easy to read.?
Directory of Professional Societies and Associations
Wherever they live and whatever their area of interest, clinical trials professionals can probably join a group of professional peers.
Glossary of Acronyms, Abbreviations, and Initials
Abbreviations don?t always mean the same thing to everyone everywhere, but these translations can help make sense of initials commonly used by clinical researchers.
DHHS, FDA, NIH Locator
A former White House advisor on health policy, Mark McClellan, is FDA's new commissioner.
Informed Consent Process
The results of a Web-based survey of some subjects in recent clinical trials suggest ways to improve the consent process.
Pediatric Clinical Trials in Germany
A survey of pharmaceutical manufacturers reveals that pediatric trials are widespread across Germany.
Update 2002 IT Solutions Directory
Our 10th annual guide to applications highlights software, Web-based solutions, and more.
Building a Home Network
Paul Bleicher examines the pros and cons of broadband Internet technology and explains how to build a home network and make it secure.
Learn Before You Leap
Putting staff training at the bottom of your list of important tasks is a self-defeating attitude in the business world.
Using IVRS in Clinical Trial Management
Integrating IVRS with in-house clinical trial management solutions can provide a powerful project management tool.
Bert Spilker
Bert Spilker has been involved in clinical trials for 30 years. He?s written books, founded companies, and helped steer regulatory agencies. Now he wants to change how drugs are developed.
The Virtual Training Process
Some companies prefer live training for PIs; some are moving toward virtual training. Two Lilly authors advocate a combination of the two methods.
Adding Centers to Boost Subject Accrual
Careful attention to geography can help sites enlarge their catchment areas and increase subject accrual rates without negative consequences.
Changing Current Practice
A set of trials carried out by the Collaborative Ocular Melanoma Study Group at eye centers throughout the United States and Canada led to improvements in the care of patients with choroidal melanoma.
EORTC's Regulatory Affairs Unit
The European Organisation for Research and Treatment of Cancer is dedicated to improving cancer treatment in Europe. Its Regulatory Affairs Unit provides important services to researchers.
Using Adaptive Interim Analysis to Calculate Sample Size in a Trial of a Treatment for Erectile Dysfunction
Adaptive interim analysis may allow smaller sample sizes when a drug?s clinical effect is unknown.
Building and Maintaining Monitor-Coordinator Relationships
Readers like Lynn Sadowski, a senior clinical research associate at Sention Inc., share their experiences.
Cross-(Dys)Functional Teams
Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.
Letters to the Editor
Readers write in with questions and comments about articles and editorials.
Developing New Drugs in 1000 Days
Everybody wants faster cycles and and quicker turnarounds with NDAs. In the U.S., will it soon be possible to go from testing to approval in 1000 days?
Paper vs. Electronic Diaries
Studies show that electronic diaries get better results than paper diaries. These authors explain why.
Letters to the editor
Readers respond to articles and editorials.
Ron Keeney
At work and play, he?s devoted to children.
Nobody Knows the Costs They?ve Seen
To judge the value of process improvement, companies need to understand the cost of doing business. The problem is: they don?t.
Measuring Investigator Satisfaction
In a global survey, Roche asks investigators how to go about getting the best clinical trial sites.
European Guidelines for Auditing Independent Ethics Committees
The European Forum for Good Clinical Practice (EFGCP) put together these guidelines as a push toward quality and efficiency in ethical review practices.
Strategies for Placing CRO Offices in Europe
In Europe, U.S. CROs aren?t doing as well as they could. Where they locate their offices could make the difference.
