Post on 01-Apr-2015
Working in and career progression within an
academic clinical trials unit
Helen Thorpe
Principal StatisticianClinical Trials Research Unit (CTRU)
University of Leeds
http://ctru.leeds.ac.uk h.c.thorpe@leeds.ac.uk
25 June 2010
CTRU background• National Cancer Research Institute (NCRI) accredited
and UK Clinical Research Collaboration (UKCRC) registered clinical trials unit
• Conduct national and international RCTs in a variety of clinical fields across NHS priority areas– Cancer Research Division – breast, colorectal, haematological
oncology, ‘other’– Health Sciences Division – mental health, stroke, obesity, care
of the elderly– Comprehensive Health Research Division – cardiovascular
disease, skin, oral health, musculoskeletal disease
• Associated methodology/research portfolio– PhD opportunities
• Collaborate with the pharmaceutical industry, NHS partners, University colleagues, clinicians, health economists, other trialists and methodologists
CTRU studies, grants and staff
• Currently ~64 trials and 13 methodological studies
• Grant income ~£2 million per year– Public funding: MRC, Cancer Research UK …– Industry funding: Novartis, Amgen, AZ, GSK …
• Currently ~90 staff members– Trial Co-ordinators / Managers– Data Managers– Statisticians– IT– Clinical Trial Associates (monitors)– Quality Assurance– Data Entry Clerks
CTRU statistics team
• Currently 15 statisticians
• Trainee Medical Statistician (1)– BSc with major statistical component
• Medical Statistician (6)– MSc and up to 2/3 years experience
• Senior Medical Statistician (2)– MSc and >2/3 years experience
• Principal Statistician (2)– MSc and >7/8 years experience
• Statistical Director of a Division (4)– MSc and >10 years experience– Management experience
Career development
• Medical Statistician– Assisting in the development and implementation of
well planned clinical trials by providing a comprehensive statistical service for the research projects undertaken by the CTRU
• Senior Medical Statistician– Develop and implement well planned clinical trials,
at a senior level, by providing a comprehensive statistical service for the research projects undertaken by the CTRU
• Principal Statistician– Working with the Director of the relevant Division,
provide statistical strategic lead and statistical supervision during the design and implementation for a number of complex trials within a specified portfolio
What does the CTRU do?
• Input into all aspects of trials activity– Grant application– Statistical design– Protocol development– Randomisation – Database design– Development of outcome measures– Data management– Compliance with research governance– Logistical issues– Statistical analysis– Interpretation of results– Publication
Trial process – part 1
• Approached by health care professional with research question OR reply to a ‘themed call’ from a research funding body
• Involved in ensuring correct trial design, endpoints, analysis etc are used in addition to sample size calculation
• Grant application with peer-review and often with 2 rounds (outline and full)
Trial process – part 2
• Once funded– Finalise protocol– Develop forms and database– Develop randomisation system– Involved in submitting ethical /
regulatory applications– Write statistical analysis plans
Trial process – part 3
• Statistical advice and monitoring during recruitment
• Involved in potential trial re-designs
• Attend various trial meetings
• Interim data monitoring reports– Safety and trial monitoring– Efficacy interim analyses
Trial process – part 4
• Programming and analysis
• Write statistical report
• Prepare abstracts, posters and oral presentations
• Present results at trial meetings, national/international conferences etc
• Involved in writing publications
Trial spin-off work
• Statistical / trial-related– Clinical sub-group analyses– Exploratory analyses– Meta-analyses– Research into new/evolving statistical
analysis techniques
• Opportunity for more publications!
Methodological research
• Involved in research outside of trial-related work– Minimisation simulations
• Opportunities for PhDs– Phase II designs and methodology– Interpretation of quality of life results
Statistical consulting
• Statistical consulting to health-care professionals
• Journal statistical refereeing
• Present internal/external statistics and clinical trial training courses
• External randomisation requests
• Research Design Service (RDS)
Other work!
• Develop CTRU Standard Operating Procedures / Guidelines
• Comment on national/international guidance documents
• Line management
• Project management
• Involved in nationwide study/advisory groups
Professional development
• Work shadow experienced statisticians
• Attend internal training courses
• Attend statistical / trial-related conferences, meetings, courses, seminars
• Membership of statistical societies e.g. PSI, RSS, ISCB, ISOQoL …
The future
• Continue to expand our portfolios and build on expertise
• More methodological research opportunities
• More projects means more staff …
Working for a university
• 25 days annual leave plus 6 days flexi leave plus additional days around bank holidays
• Flexi-hours
• University-pension
• Student Union facilities!
Working for the CTRU• Away days• Sports day • Comic Relief• Race for life• Stats lunches• The Fav!
Any questions?