COURAGE trial

Shaw LJ, Berman DS, Maron DJ, et al. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation 2008 Mar 11 117(10) 1283-91. 

We dedicate this book to the students from whom we continue to learn, to the patients who have had the courage to participate in early gene therapy clinical trials, and to the fellow colleagues who help keep up the pace. 

This is a political trial of a very peculiar nature , the courageous Viennese attorney threw at the judge and State Attorney. For the reason that it deals with a crime of opinion, where there was no violence. 

Unfortunately, the actions of Federal German - as they are graphically demonstrated by Manfred Kohler and borne out by the experiences of many defense counsels in such trials - allow only the opposite conclusion, namely that the trial of Gottfried Weise is nothing short of a model for thousands of other cases. Only the facts that Herr Weise had many courageous friends who helped him every minute of their spare time and that his trial continued into a time where new evidence has... 

It needs compassionate, courageous, scientifically well-trained clinicians to do clinical trials. Not all physicians are willing to take part in a trial because there are many potential risks in agreeing to be involved and few, if any, benefits except the rare outcome of the physician then becoming an opinion leader in his or her field of medicine. 

One needs conviction to move forward in clinical development. It bears emphasizing that one needs compassionate, courageous, and scientifically well-trained clinicians to do your clinical trials, and the strength of their conviction will help in determining how to proceed. Even if you are working through a CRO it is good to have some direct access to the physicians. The better you know them, the better chance of success. 

All of which is okay, because about 60 percent readiness for independence is about the best parents can hope for. The late adolescent has to pick up the balance from the Big RRealitythrough the trial-and-error learning that opportunity and adversity provide. If parents and the late adolescent wait to separate until he or she is entirely ready for independence, separation will never begin. For the young man or young woman, the courage of late adolescence is to... 

Confusion arises when lack of direction creates fear of an undetermined future. Courage is going forward when you don t know which way to go. Parents need to avoid the double message "We want you to make your own choices, but we don t want you to make the wrong ones." Instead, acceptance of uncertainty would help "It takes exploring, and trial-and-error learning, for people to figure out what they want to do in life."... 

None of the research described in this chapter could have been performed without the selfless, courageous, and generous participation of the numerous lymphoma patients who volunteered for the initial clinical trials. This is particularly true of those who participated in our Phase I trials, at a time when the efficacy and safety of the antibody were unknown. They had hope, faith, and courage. They trusted us with their lives. Without these heroes, Rituxan would not exist today. We (the researchers), and the many patients who will benefit from their participation in these studies, owe them a debt of gratitude. 

The general pharmaceutical physician cannot be expected to be able to generate Bayesian statistical plans for him/herself. These require an experienced statistician and, it may be added, a statistician who is not, him/herself, philosophically opposed to Bayesian rather than frequentist thinking. The decision to employ a Bayesian design for a clinical trial will be viewed as courageous in most companies, and there will be many clinical trials for which an orthodox, frequentist approach will be selected, for several good reasons. Overall, the gen-... 

A courageous citizen, Halle, read a detailed account of Lavoisier s discoveries and his services to his country before the Tribunal, but without result. Many legends soon appeared about his trial, e.g. that Coffinhal, presiding over the Tribunal, when asked to spare a man of science said The Republic has no need of savants justice must take its course. These stories are probably apocryphal. ... 

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