Kirby Seminar - Mrs Dena Howard - "Incorporating Emerging Therapies into Ongoing Randomized Clinical Trials: Improving Efficiency and Relevance."

Image - Kirby Seminar - Mrs Dena Howard - "Incorporating Emerging Therapies into Ongoing Randomized Clinical Trials:  Improving Efficiency and Relevance."
Event type: 
Seminar
Event date: 
Monday, 14 September 2015 - 1:00pm to 2:00pm
Location: 

The Kirby Institute
Level 6 Seminar Room
Wallace Wurth Building
UNSW Australia
Sydney NSW 2052

Contact for inquiries: 
Rata Joseph +61 (0)2 9385 0900 rjoseph@kirby.unsw.edu.au
Booking deadline: 

The Kirby Institute is pleased to present:

Mrs Dena Howard-Principal Statistician & NIHR Doctoral Research Fellow, Leeds Institute of Clinical Trials Research, University of Leeds.UK

"Incorporating Emerging Therapies into Ongoing Randomized Clinical Trials:
Improving Efficiency and Relevance."

Abstract:
Adding a treatment arm to a trial that is already open to recruitment is desirable to researchers, regulators, funders and patients to ensure that new treatments are evaluated as quickly as possible and resources are optimized. However, this is not something that is commonly done in practice.
 
Two ongoing trials at the Leeds Institute for Clinical Trials Research, UK, have implemented or are planning to implement amendments to add new treatment arms at different stages of recruitment. These trials will be described and the benefits and challenges of this type of amendment discussed.
 
A comprehensive literature review was undertaken to assess the extent that this topic has been considered within publications. This included either statistical methodology or practical implementation within trials. There is currently very little literature regarding statistical methods and design considerations to ensure that the research integrity is not compromised when adapting a trial in this way. A small number of trials were identified to have added treatment arms, although they did not always address the statistical considerations to ensure that their research objectives could be fully met.
 
Key statistical considerations that are necessary to address when adapting a trial by adding a new treatment arm have been identified from the literature, research and practical experience, and will be discussed. 

Bio:
Dena Howard is a Principal Statistician at the Clinical Trials Research Unit, University of Leeds, UK. She provides statistical and methodological leadership for the Chronic Lymphocytic Leukaemia (CLL) portfolio of trials within the Cancer Research Division. In addition, she is undertaking a part time Doctoral Research Fellowship, funded by the National Institute for Health Research (NIHR), to investigate the statistical implications of adding an arm into an ongoing randomized controlled trial.  

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