Advancing Clinical Trials in Oncology

Cambridge, United States (August 25-26, 2010)

Understanding the Effective Design and Execution of Oncology Clinical Trials

As I'm sure you're aware, the progression of drug candidates through the clinic is a double-edged sword. Get it right and your hardwork pays off, get it wrong in confirmatory studies and the financial implications can be enormous. Understanding optimal trial design strategies and the regulatory requirements is critical to clinical success.

Drawing on the experiences of the world's leading anticancer drug developers (including Novartis, Genentech, Johnson & Johnson, GlaxoSmithKline, Merck, Pfizer, EMD Serono, Bristol-Myers Squibb and many other pioneering biotechs) we developed an agenda that delivers practical value and clear coverage of the central topics right now.

What's being covered on the Agenda?

Key areas being focussed on include;

* Reducing attrition rates in oncology drugs in the clinic through better trial design

* Incorporating adaptive trial design into oncology trials

* Benefits of randomised controlled Phase II trials vs single-arm uncontrolled trials

* Importance of the Independent Review

* Understanding what constitutes a ‘result’ in patient response

* Assessment of clinical endpoints in oncology       o How to implement the latest FDA guidelines on Progression-Free Survival (PFS) endpoints

* Effective Strategies to develop successful companion diagnostics       o Translating preclinical biomarkers into the clinical setting       o Trial design strategies to identify biomarker subpopulations during ongoing clinical trials

* Challenges and opportunities for global oncology operations

* Streamlining operational protocols to identify and remove process bottlenecks       o Maximising patient recruitment and retention through international collaborative groups       o Building effective partnerships with CROs and clinical research groups

* Improving communication in comparative effectiveness research in clinical trial design       o Understanding decision critical data for reimbursement appraisals       o Integration of requirements into effective trial design

Why Attend?

* Understand the latest research efforts in oncology clinical trial design to streamline drug approval success

* You will leave the meeting with a variety of new ideas and contacts to take back to your research organisation

* The Biorbis Advancing Clinical Trials in Oncology conference focuses on delivering practical value, accelerating progress of drug candidates through the clinic and maximising the speed to market for your cancer therapy

Více: http://www.hansonwade.com/events/advancing-clinical-trials-in-oncology