Workshop on single-arm trials in oncology

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TitleWorkshop on single-arm trials in oncology
Date30/06/2016 - 30/06/2016
LocationEuropean Medicines Agency, London, UK
SummarySituations in which a medicine shows significant anti-cancer activity in an area where patients have no treatment option or where the conduct of standard trials with a comparative arm is difficult, such as in rare cancers or selected populations for example, will be considered. Workshop participants will discuss experience gained so far with marketing authorisations based on single-arm trials data, the strengths and weaknesses of different approaches, and opportunities from data sharing initiatives. They will also explore the views of various stakeholders groups and discuss the need for further regulatory guidance with the ultimate aim of optimising the development of new cancer treatments in these situations.

All documents

Name Language First published Last updated
Agenda - Workshop on single-arm trials (SAT) in oncology (English only) 2016-05-20 2016-06-23
Presentation - Single-arm trials in cancer drug evaluation - Problem statement (Francesco Pignatti) (English only) 2016-08-15  
Presentation - Crizotinib in patients with ROS1+ non-small cell lung cancer: rationale and results (Mace L. Rothenberg) (English only) 2016-08-15  
Presentation - Use of single arm cohorts/trials to demonstrate clinical benefit for breakthrough therapies and results (Eric H. Rubin) (English only) 2016-08-15  
Presentation - Uncontrolled evidence in rare cancers (Paolo G. Casali) (English only) 2016-08-15  
Presentation - The role of single arm trials in Oncology drug development(Gideon Blumenthal) (English only) 2016-08-15  
Presentation - How to improve the reliability of single arm trials (Paolo Bruzzi) (English only) 2016-08-15  
Presentation - Project Data Sphere®: Progress & Promise - Single-arm trials in cancer drug evaluation workshop (Martin J. Murphy) (English only) 2016-08-15  
Presentation - Single arm trials in the context (era) of platforms (R. Kaplan) (English only) 2016-08-15  
Presentation - Clinical trial design- the patient standpoint (Bettina Ryll) (English only) 2016-08-15  
Presentation - Clinical research in small patient populations: the investigator point of view (Jordi Rodon) (English only) 2016-08-15  
Presentation - Single-arm trials a good step towards faster access/reimbursement of drugs? (with an added value for ‘all’ patient…) (Mattias Neyt) (English only) 2016-08-15  

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