clinical trials

I have been away from my desk for most of the week following my 17th course of chemotherapy. The day before the treatment I had a gruelling three hour session with two other CLL experts in a conference call reviewing cases from a clinical trial. WE are still using the 1996 Guidelines to judge the quality of remissions. It is extraordinarily difficult to make a judgment in these cases. In certain areas the Guidelines are imprecise and sometimes the local investigator has omitted a vital piece of evidence. Given that this is a multi-center study with Middle-European investigators as well as American ones, multiculturism raises it's ugly head and some of the language translations are comical. We sometimes refer to the 2008 Guidelines, but although they resolve some questions, they still leave vacuums where we get the wrong answer, even though our answer is correct.

When judging a new agent in a clinical trial, surely the right question is, "Has the treatment done the patient any good?" It is possible to achieve MRD negativity without benefiting the patient.