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.
Successful Subject Recruitment: One Size Does Not Fit All
Successful recruitment requires a good fit between the subjects, the sites, and the protocol. Here?s how to assess the necessary tailoring of procedures.
The HIPAA Privacy Rule Affects Subject Recruitment
A health care attorney clarifies how amendments to the HIPAA Privacy Rule bear on the recruitment of clinical trials subjects.
Planning Helps Project Managers and CRAs Meet the Challenges of: The Move to EDC
Good organization and technological support are needed to bring the benefits of electronic data capture to a clinical trial.
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.
Radiology in Oncology Trials: Critical Success Factors
Modern radiological techniques and digital analysis technologies permit rapid evaluation of the efficacy of oncology drugs. Continual review of methods detects flaws promptly, creating the opportunity to take corrective steps.
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.
Electronic Diaries, Part 1: What Is a Subject Diary, and How Do Regulations Apply?
Experts discuss the use of subject diaries and the way researchers can comply with applicable regulations and guidelines.
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.
Scaling up EDC: How to Move Away from Paper Trials
After years of pilot trials, the pharmaceutical industry still sees EDC as something new. Here are two approaches toward making EDC into business as usual.
Supporting EDC in a Clinical Trial Environment
Support can be key to a successful EDC clinical trial. These suggestions may help your organization achieve a better experience with EDC.
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.
Why Aren't More Pediatric Trials Performed?
Successful pediatric research requires partnership between the pharmaceutical industry, investigators, ethics committees, and parents.
Letters to the editor
Readers respond to articles and editorials.
Practical and Ethical Issues in Pediatric Clinical Trials
Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.
Pediatric Clinical Studies in Japan: Regulations and Current Status
In Japan, pediatric clinical trials face obstacles, but new regulations give manufacturers incentive to conduct them.