Investigators and Sites: Answers to Questions about Good Clinical Practice
October 1st 2003Earlier this year, Applied Clinical Trials published "Clinical Monitoring: Answers to Questions about Good Clinical Practice," another excerpt from the book, Good Clinical Practice: A Question & Answer Reference Guide. Readers are referred to the July 2003 issue (pages 27-29) to read the full text of the reference guide introduction.
Forced Randomization: When Using Interactive Voice Response Systems
October 1st 2003Interactive voice response systems are commonly used in clinical trials to manage the flow of trial medication supplies to sites and to manage the allocation of these supplies to individual subjects. Other advantages and uses include access to real-time information for trial managers, collection of diary card data directly from subjects, and as an aid to subject recruitment.1
Biomarkers and Surrogate Endpoints in Clinical Drug Development
July 1st 2003Both large and small pharmaceutical companies have learned that the value of their development candidates increases once clinical research has demonstrated their proof of concept. Sponsor companies face the challenge of moving new blockbuster drugs to market as rapidly as possible.