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?