Articles
Commentary; Adaptive Trials in Practice
A clear understanding of practical and operational issues is equally critical for successful use of any adaptive technique, whether for strategic (design) or tactical (operational, such as enrollment) aspects. I will address some of the more common confusions encountered when implementing adaptive processes.
Article posted: Monday, November 19, 2007
The Systems that Enable an Adaptive Approach
The true test of the suitability of data collection and processing systems for adaptive studies is more than a measure of discrete activities at the input stage, says Michael Rosenberg, CEO of Health Decisions.
Article posted: Wednesday, October 31, 2007
Decisions, Decisions: Michael Rosenberg on Adaptive Research
Knowing adaptive trials require fast decision-making by study sponsors and research teams, Michael Rosenberg, MD, MPH, built a clinical research organization 18 years ago to help them do it.
Article posted: Thursday, September 6, 2007
Adapting to Adaptive Designs
Out with the old, and in with the new for clinical development. Michael Rosenberg discusses the importance of moving towards adaptive trials.
Article posted: Sunday, April 1, 2007
Adapting to Adaptive Studies
Michael Rosenberg reviews the organisational foundations for conducting adaptive studies most productively and explains why web-based EDC systems are not up to the task.
Article posted: Sunday, April 1, 2007
A Faster, Less Costly Route to New Drugs
An op-ed piece by Health Decisions CEO Michael Rosenberg.
New data from the Food and Drug Administration and a December report from the Government Accountability Office leave no room for doubt: the pharmaceutical industry is experiencing a productivity meltdown of historic proportions...
New data from the Food and Drug Administration and a December report from the Government Accountability Office leave no room for doubt: the pharmaceutical industry is experiencing a productivity meltdown of historic proportions...
Article posted: Friday, March 2, 2007
Electronic Clinical Trials: The Way Forward in Clinical Development
Web-enabled clinical trial technology is undoubtedly changing the way that drug development is performed. The key to success is recognition that improved efficiency and reduced cycle times will not be achieved through technology alone…
Article posted: Thursday, January 25, 2007
CenterWatch Weekly Profile: Health Decisions
An interview with Health Decisions founder and chief executive officer, Michael Rosenberg.
Article posted: Monday, January 22, 2007
Re-Thinking EDC
We thought we were done. We thought the controversy about electronic data capture (EDC) was resolved. Once again, we were wrong.
Article posted: Tuesday, September 19, 2006
Pharma Has the Data But Not the Information: Why Process Matters
Are you involved with Clinical research? If so, take a moment to imagine what if every clinical research assistant, monitor and project manager working with a study were given a personal assistant to be at their sides at all times, watching everything, and keeping track of all the details of the study...
Article posted: Friday, September 1, 2006

