Controversy Around Clinical Trials Approval Endpoints - US Regulatory History of Avastin at Optimising Clinical Development in Oncology



Pharma IQ News
01/05/2011

Gary Acton, CMO from Antisoma will explore the challenges the contemporary controversy around clinical trials approval faces at Optimising Clinical Development in Oncology, 15th-16th March 2011 in London.

Gary Acton will take the example of the US regulatory history of Avastin in metastatic breast cancer, running from 2001 to December 2010, to illustrate the contemporary controversy around clinical trial approval endpoint, the issue of quality life assessment and the potentially impossible hurdle of demonstrating survival advantages in the context of the complexities of current clinical management of the oncology patient. The entire concept of regulatory ''accelerated approval'' will be reviewed as well as the role of cost containment in the determination of the approvability of expensive new interventions.

Investigating the Avastin Case Study is one of the workshops taking place as a part  of the Optimising Clinical Development in Oncology conference. The meeting aims at investigating new trial design approaches, efficient application of biomarkers and patient recruitment strategies to drive oncology clinical development and speed time to market. 18 industry experts that will gather in March in London include: 

  • Prof. Dr. Karol Sikora, CancerPartners UK
  • Philip Murphy, Pfizer
  • Alun Beddong, GSK
  • Maria Orr, Astra Zeneca
  • Ekkehard Glimm, Novartis
  • Julian Howell,ProStrakan
  • Mika Mustonen, Orion Pharma

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Optimising Clinical Development in Oncology is co-located with Optimising Clinical Development for CNS as a part of Clinical Trials Summit. If you want to find out more, please go to www.oncologysummit.co.uk or www.clinicalcns.co.uk.