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.
Ron Keeney
At work and play, he?s devoted to children.
Clinical Research in Mexico: An Overview
The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
Good Clinical Practice: 10 Steps for Improving FDA GCP Inspections
European inspectors are doing a better job of implementing ICH GCP guidelines than their American counterparts at FDA. Here are 10 ways U.S. inspectors could improve their inspection process.
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.
Interpretation of Regulatory Requirements by Technology Providers: The Case for Electronic Source Data
The authors contrast two views on the regulations concerning electronic source data.
HIPAA Privacy Rule: Effect on Medical Research
An attorney who specializes in health law advises researchers and research organizations to study and put into practice the proposed changes in a rule that governs use and disclosure of protected health information.
Ethical Review and the Globalization of Clinical Trials
As clinical trials become global affairs, more effort should be devoted to the protection of research subjects. However, the question of consistency among ethics committees looms.
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.
Identifying and Documenting Adverse Events at Clinical Study Sites
Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.
Brian Koziol
Family man, educator, mentor, athlete--and a man on a quest with Amgen Inc for new and better oncology treatments.
A Model-Based Method for Improving Protocol Quality
A new method, based on hard-earned experience, can help you reduce the risk of protocol inconsistencies and ambiguities during the protocol development process.
A Multidisciplinary Approach to Data Standards for Clinical Development--Progress Update
The pharmaceutical industry spends more than $156 million each year to support data transfer, and all involved parties could benefit from common interchange standards.
When Process Improvement is Skin-Deep
Many re-engineering projects neglect the nuts and bolts that are needed to make strategies a reality.
Communicating in the Information Age: It?s Still All About Human Behavior
Technology can do only so much; understanding human behavior and psychology is the key to improving your communication skills.
Consider Geography When Choosing Investigative Sites
An essential aspect of selecting the location for an investigative site is the population surrounding it. Here is a method for determining how many potential subjects are available to your investigators.
Meet the Editorial Advisory Board Francis Crawley
Through open discussion and dialogue, and by promoting understanding and trust, Crawley?a longtime member of the European Forum for Good Clinical Practice?champions ethical research.
