Workshop on single-arm trials in oncology

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Date: Ceturtdiena, 30 Jūnijs 2016, Visu dienu
Vieta: European Medicines Agency, Amsterdam, the Netherlands

Situations 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.

Documents

Agenda - Workshop on single-arm trials (SAT) in oncology

Draft Reference Number: EMA/328790/2016

English (EN) (73.85 KB - PDF)

Pirmo reizi publicēts: 20/05/2016 Pēdējo reizi atjaunināts: 23/06/2016

Presentation - Single-arm trials in cancer drug evaluation - Problem statement (Francesco Pignatti)

English (EN) (513.96 KB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Crizotinib in patients with ROS1+ non-small cell lung cancer: rationale and results (Mace L. Rothenberg)

English (EN) (1.48 MB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Use of single arm cohorts/trials to demonstrate clinical benefit for breakthrough therapies and results (Eric H. Rubin)

English (EN) (737.27 KB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Uncontrolled evidence in rare cancers (Paolo G. Casali)

English (EN) (5.08 MB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - The role of single arm trials in Oncology drug development(Gideon Blumenthal)

English (EN) (1.38 MB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - How to improve the reliability of single arm trials (Paolo Bruzzi)

English (EN) (1.2 MB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Project Data Sphere®: Progress & Promise - Single-arm trials in cancer drug evaluation workshop (Martin J. Murphy)

English (EN) (1.51 MB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Single arm trials in the context (era) of platforms (R. Kaplan)

English (EN) (967.2 KB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Clinical trial design- the patient standpoint (Bettina Ryll)

English (EN) (869.69 KB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Clinical research in small patient populations: the investigator point of view (Jordi Rodon)

English (EN) (9.65 MB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Presentation - Single-arm trials a good step towards faster access/reimbursement of drugs? (with an added value for ‘all’ patient…) (Mattias Neyt)

English (EN) (881.78 KB - PDF)

Pirmo reizi publicēts: 15/08/2016 Pēdējo reizi atjaunināts: 15/08/2016

Multimedia