Introduction to the Clinical Trials Research Unit Professor Julia Brown, Director Clinical Trials Re

1
Introduction to the Clinical Trials Research
UnitProfessor Julia Brown, Director Clinical
Trials Research Unit
2

• Set up 20 years ago as a cancer trials unit
• Core funding from NHS R and D since 1998
• Current Department of Health Core Programme Grant
  2006-2010
• In 1992 extended remit to non cancer
• In 1998 CTRU joined University of Leeds
• In 2004 LTHT collaboration joint posts for QA,
  Statistics, NIHR Programme building (2007)

3

• Clinical trials are the gold standard
  methodology for the evaluation of treatments or
  interventions in healthcare, designed to compare
  efficacy and safety/toxicity
• Phased approach
• Phase I
• First in man
• Phase II
• Initial clinical investigation for clinical
  effect
• Small numbers (20-30 patients)
• Minimum effective dose, screening process,
  feasibility issues
• Phase III
• Full scale evaluation of treatment
• Large number of patients
• Long term follow-up
• Used for drug licensing application in industry
• Phase IV
• Post marketing surveillance
• Long term monitoring
• Marketing

4
Areas of expertise and interest

• Clinical Trials Portfolio
• Complex interventions
• Complex designs
• Trials requiring multidisciplinary input
• Trials involving a range of health care
  professionals ( link with health economics,
  health sciences)

5
Current clinical trials research

• Cancer (breast, haematological, colorectal),
  cardiovascular disease, older people
• 27 Multi-centre clinical trials (phase 2-phase 4)
• Bolt on studies (genomics, proteomics)
• National/international recruitment
• In 2003 National Cancer Research Institute
  Accredited

6

• Specific industry collaboration section 8 phase
  II/III trials
• Established in 1997
• Good reputation- studies to time, on budget
• ATAC Trial - risk reduction of 14 in time to
  distant recurrence for post-menopausal breast
  cancer patients treated with anastrozole as
  opposed to tamoxifen

7
Methodological research

• 11 methodological studies
• Qualitative and quantitative approaches
• psychosocial research
• informed consent
• meta analysis
• statistical methodology
• National/international collaboration

8
Project Grant funding

• All staff on project grant funding
• Department of Health
• MRC
• CRUK
• Wellcome Trust
• Smith and Nephew Foundation
• Industry
• NHS HTA, SDO, Methodology Programme

9
Expertise staff

• Clinical trial methodologists
• Information Systems 24 hour automated
  randomisation service, electronic remote data
  capture systems
• Site Monitoring
• Statistics
• Systematic reviews
• Trial management
• Quality assurance
• Qualitative research

10
CTRU Activity 2001 -2006
11

• Any questions?

12
Musculoskeletal Interventions and outcomes

• Not my research area !
• Area with strong track record in clinical trials
  research
• Series of individual grants
• Brainstorming re key issues to resolve
  components required to build programmes