Introduction to Clinical Trials
Introduction to Clinical Trials The history of drugs has never been a particularly attractive subject in medical education, and one reason for this is that it is so unbelievably deplorable…
Collecting and Interpreting Life Events Data in Clinical Trials
Collecting and Interpreting Life Events Data in Clinical Trials If you want to live a happy life, tie it to a goal, not to people or things. –Albert Einstein The…
Designing and Implementing a Clinical Trial
Designing and Implementing a Clinical Trial One doesn’t discover new lands without consenting to lose sight of the shore for a very long time. –Andre Gide (1869-1951). Discovery consists in…
Questions to Ask about a Clinical Trial Protocol
Questions to Ask about a Clinical Trial Protocol There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance. –Hippocrates (460-377 BC). Science is organized…
Creating a Clinical Strategy and Development Plan for a New Drug or Indication
Creating a Clinical Strategy and Development Plan for a New Drug or Indication It is a good morning exercise for a research scientist to discard a pet hypothesis every day…
Evaluating a Portfolio of Investigational Drug Projects
Evaluating a Portfolio of Investigational Drug Projects Trying to assess basic research by its practicality is like trying to judge Mozart by how much money the Salzburg Festival brings in…
Introduction
Introduction This section can only present a brief synopsis of selected issues regarding clinical trials. These chapters are not intended as a primer on how to conduct clinical trials, but…
Developing Standard Operating Procedures
Developing Standard Operating Procedures There is no more difficult art to acquire than the art of observation, and for some men it is quite difficult to record an observation in…
Productivity and Project Success
Productivity and Project Success Measures of productivity are like statistics on accidents: they tell you all about the number of accidents in the home, on the road, and at the…
Overview of Safety and Risk Management
Overview of Safety and Risk Management Drugs, like life, are not risk free. –Anonymous DEFINITIONS AND USES OF THE TERMS SAFETY AND RISKS Safety is a frequently used word in…
