The PACE Trial

1
The PACE Trial

• Julia DeCesare
• Trial Manager
• PACE Trial Coordinating Centre (PTCC)
• Queen Mary University of London

2
The PACE Trial

• The challenges of setting up the PACE trial from
  a Trial Managers perspective in the current
  regulatory climate

3
The PACE Trial

• Short title of trial
• Pacing, graded Activity, and Cognitive behaviour
  therapy a randomised Evaluation
• Long title of trial
• A randomised controlled trial of adaptive pacing,
  cognitive behaviour therapy, and graded exercise,
  as supplements to standardised specialist medical
  care versus standardised specialist medical care
  alone for patients with the chronic fatigue
  syndrome / myalgic encephalomyelitis or
  encephalopathy

4
Trial design
600 patients in 6 UK secondary care specialist
chronic fatigue clinics
SSMC Alone
APT SSMC
CBT SSMC
GET SSMC
12 months follow-up
12 months follow-up
12 months follow-up
12 months follow-up
5
1. The challenges

• Ethics approval
• First approved 31 March 2003
• Final approval 02 February 2005
• Caught between two systems
• Process of piloting therapies
• Volume of trial materials
• Disease poorly understood

6
2. The challenges

• Staff recruitment
• Shortage of therapists
• AfC and manualised therapies
• Retention of staff (unusual career path)
• Compliance with manuals
• Therapy is not as easy to administer as a drug
  supply!

7
2. The challenges

• Freedom of information Act
• Controversy of trial
• Enquiries for sensitive documentation
• Clinical trial but not a drug trial
• Working within guidelines that dont always apply

8
3. The challenges

• Participant compliance
• Large number of visits for a fatigued population
• 5 research visits
• 15 therapy sessions
• 3 (minimum) sessions with a doctor
• Harder to judge compliance
• with therapy
• completion of homework (no pills to count!)

9
4. The challenges

• Measurement load
• Poorly understood syndrome
• Multiple possible contributing factors
• Perceptual process
• Many, many measurements, thousands of Case
  Report Forms and an enormous quantity of data
  points to check!

10
1. The Advantages

• No drugs!
• No QP
• No labelling
• No drug accountability
• No pharmacy contracts or audits
• SUSARs and side effects unlikely
• No MHRA registration
• No fees
• Less likelihood of inspection
• No EUDRACT database reporting
• Always new and interesting!

11

• Pacing, graded Activity, and Cognitive behaviour
  therapy a randomised Evaluation