XOMA. Bull or Bear? Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : XOMA. Bull or Bear?

XOMA 31.88

+0.2%

3:59 PM EST

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: Cacaito who wrote (14705)	9/17/2000 3:26:45 PM
From: manfredhasler	Read Replies (2) of 17367

Cacaito, Re: informed consent and logistical nightmare Pharmaceutical company sponsored clinical trials are by definition profit oriented. No question that a supervision of an "unbiased" Institutional Review Board (or Ethical committee) is warranted for study justification and control. No objections against a DSMB (data safety monitoring board) as well because one of their tasks and responsibility is to stop a trial if considered no more ethical. I mean I do not have any problem at all with the very basics of the logistics. By no means however all these committees are taking over responsibility for the study. Responsibility lies with the investigators. And by no means these committees can be taken to serve as shield for a failure in a study execution. Contrary to what you say I do believe that for real fundamental clinical research your logistic nightmare in mind is a complete non-issue. BPI in meningococcemia was a pivotal study design for a new treatment. And no rule exists anywhere in the world that prevents any form of progress in clinical medicine. If logistic or ethical problems arise (in our study for instance the administration of a drug before informed consent can be given in a life threatening situation) this needs a involvement of the clinicians in the study design. It needs some discussion and problem solving. Anything allowed that would prevent a proper execution of a study would be unethical. The study protocol just has to be negotiated with the supervisory committees to get it scientific sound. And now a very special point: if clinicians behave like whores prostituting themselves to the pharmaceutical industry and trying to reap a benefit out of anything they might get, and not caring about the study protocol, and pretending they are the big scientist in case of success or bound by logistics in case of failure, I would object the merit of clinical research as well. In this case I would be with Robert, GW and Bluegreen: clinical medicine would be wrong, the FDA would base the decisions on false premises. Probably this was hard for you. But no attack meant. Because actually I do not believe in such a system. I am sure, any objections to a study design can be discussed and solved within a sound study design. All, the investigators, the supervisory boards, the sponsoring company involved with their interest in mind have to find a way. Logistical nightmares excluded. A proper execution of a study in mind. The whole organisation is part of the scientific community. At the end controlled by the FDA (in the US). I am positive on the medical progress. And if our study in question was messed up I am interested for what reason. I tend to restrict the problem to the clinicians involved. I tend to think the whole problem in logistic was the problem of clinicians that did not care much about their responsibilities. I will take care of just that point in my further evaluation. Let us make a reality check: clinical studies are needed by the pharmaceutical industry but they are of use as well for the clinicians and the hospitals. The clinicians get some academic benefit as well as some of the funding along with the hospitals. Conflict of interest? Who cares about conflicts of interest if the execution is perfect. Regards, Manfred

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next