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Hayley Timmins

Trial Manager

Overview

I have worked within Cancer Clinical Trials for over 15 years. I began my time in trials working at Velindre Cancer Centre Trials Unit. I gained valuable experience in setting up oncology trials within the hospital environment whilst liaising with local R & D departments and Oncologists as well as supporting the Research Nurses within the Team.

I now work at the Centre for Trials Research as a Trial Manager and have worked across a variety of studies at different stages of their development including both CTIMPs and Non-CTIMPs.

In more recent years I have been more heavily involved with promoting and setting up one of our Phase III trials, PATHOS, internationally which involves communicating well with international teams and adapting to their way of working. I have also worked closely with the European Organisation for Research and Treatment of Cancer (EORTC) over the past 3 years as an International Sponsor to progress the Best-Of trial in order to maximise its potential for opening sites and recruitment of patients here in the UK.

Biography

Trial Manager, CTR 2008 - current

Data Manager, WCTU 2007 - 2008

Research Administrator, Velindre NHS Trust 2005 - 2007

Research Assistant in Evidence-Based Medicine Aug 2004-Sept 2005

Publications

I am currently working on the following studies:

OPEN

PATHOS - A Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)-positive oropharyngeal cancer. The aim of the study is to assess whether swallowing function can be improved following transoral resection of HPV+ OPSCC by reducing the intensity of adjuvant treatment protocols, without resulting in inferior survival outcomes.

Best-Of - Phase III study assessing the “best of” radiotherapy compared to the “best of” surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma. The main aim of the study is to assess and compare the patient-reported swallowing function over the first year after randomisation to either IMRT or TOS among patients with early stage oropharyngeal (OPSCC), supraglottic squamous cell carcinoma (SGSCC), and hypopharyngeal squamous cell carcinoma (HPSCC).

IN DEVELOPMENT

ABC-12 - Exploring the microbiome in patients with advanced biliary tract cancer in a first-line, randomised study of durvalumab (MEDI4736) in combination with cisplatin/gemcitabine versus placebo in combination with cisplatin/gemcitabine. Th aim of the study will be to determine the difference in baseline alpha diversity (number of species present in microbiome samples) between “responders” (partial and complete response) and “non-responders” measured at 18 weeks (by RECIST 1.1) in patients treated with durvalumab (ARM A).