1. Working in and career progression within an academic clinical trials unit Helen Thorpe Principal Statistician Clinical Trials Research Unit (CTRU) University of Leeds http://ctru.leeds.ac.uk h.c.thorpe@leeds.ac.uk 25 June 2010

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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)

8. 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

9. 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

10. 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

11. 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!

12. 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

13. 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)

14. Other work! Develop CTRU Standard Operating Procedures / Guidelines Comment on national/international guidance documents Line management Project management Involved in nationwide study/advisory groups

15. 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 …

16. The future Continue to expand our portfolios and build on expertise More methodological research opportunities More projects means more staff …

17. 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!

18. Working for the CTRU Away days Sports day Comic Relief Race for life Stats lunches The Fav!

19. Any questions?