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Learning to run Cancer Clinical Trials article on Sci Careers website

PostPosted: Fri Mar 25, 2011 10:25 am
by D.X.
Hi all,

just wanted to direct attention to the "running Cancer Clinical Trials" article on Science Careers page.

They refer to a couple courses there on how to write protocols and execute phase II and phase III studies. I think this is important to for those considering more clinically-oriented careers and are looking for formal training. They refer to a Cancer setting here, but the fundamentals are the same accross indications.

In my job, I review and approve from a Medical Affairs perspective phase II through phase IV protocols, I have never had formal training on this, so I've learned via experience, I still have many gaps in my knowledge. Something like this would be valueable to me (despite my current job function) and thus I would expect be valueable to others. I have only been trained in Good Clinical Practice (ICH-GCP) which is mandatory in all companies.

I'm not sure if these courses described in these articles are available to non-physicians, but do consider many non-physicians are involved in the protocol writing process and alot of Ph.D.s work in Clinical Development in Pharma.

Not only that, but I think these courses appear to give insight into the logistical needs of running a trial (sample size determination, blood sample handling, resources, ethicial sign-offs etc.) which is something, I am still getting a grasp on (usually I handling by asking the submitting Country Medical Directors to explain how all the resources are provided for etc.). Once I think everything is accounted for I give my MA sign-off, I let the guys/girls in Clinical Development and Operations fight over the nitty gritty.

So, anyway, I point to this as to what I think is a great "formal" education opportunity that one may wish to investigate at their respective universities for those who have interest in developing some clinical accumen (especially as it relates to end-point determination etc). Perhaps its part of a course to residents? Maybe you can get your deans to get you access to something like this as part of your individual development/interest area.

Anyway, thought it was interesting and worth attention.

Good luck!