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.
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.
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.
9th ACT European Summit
Selecting Sites and Investigators
The system is an important part of the selection equation in CEE nations where sponsors must contract with institutions rather than investigators. Examples from Hungary offer guidelines for improving selection SOPs.
Data Delivery During Crisis
Eli Hauser and Paul Bleicher No matter how much a company spends on risk management, it can never prevent all loss. But setting priorities and establishing a risk management strategy can minimize the potential consequences.
Diamonds May Be Forever, But Data?
Future retrieval of vital clinical data depends on having a strategy to deal with the rapid obsolescence of computer software and hardware.
EDC, RDE, OCR: We speak the same language–or do we?
Readers share their experiences