1. THE MEDICAL RESEARCH NETWORK
A ‘Clinical Trial Support Organisation’ (CTSO)
The Trial Site & Beyond!
Stuart Redding, Director
www.themrn.co.uk

2. The Trial Site & Beyond!
Feasibility …
What
When
Why
© Medical Research Network 2007 www.themrn.co.uk

3. The Trial Site & Beyond!
Key Stakeholders in Patient Recruitment ...
Sponsor / CRO Investigator Patients
© Medical Research Network 2007 www.themrn.co.uk

4. The Trial Site & Beyond!
And their perception of clinical trials ...
Sponsor Investigator Patients
Each day a drug is
delayed from market,
sponsors lose up to $8
million
© Medical Research Network 2007 www.themrn.co.uk

5. The Patient’s Perception
© Medical Research Network 2007 www.themrn.co.uk

6. Factors Influencing Patients
The Protocol & Study Design
• The Site Staff & Facilities
© Medical Research Network 2007 www.themrn.co.uk

7. Factors Influencing Patients
• The Protocol & Study Design
– Visits
• Total Number – Overall Trial Commitment
• Frequency – Travel Cost, Distance, Time & Stress
• Length – Time Commitments
– Assessments
• Blood Draws – Necessity & Discomfort
• Infusions - Time & Discomfort
• QOL – Time & Repetition
– Drug
• Safety & AEs – Risk of Participation
• Placebo – How will Illness Progress
© Medical Research Network 2007 www.themrn.co.uk

8. What Can We Do - Protocol
• Keep It Simple!
– Limit Site Visits
– Limit Assessments
– ‘Steamline’ Endpoints
– Consider Home Care Visits
• Take The Trial to the Patient
• Reduce Visits to Site
• Make Trials More Appealing
• Can Account For Up To 50% of a Trial’s Visits
• Shown to Increase Recruitment Rates
Up to 60%
• Shown to Maintain Retention Rates At
Over 90%
© Medical Research Network 2007 www.themrn.co.uk

9. What Can Be Done In The Home
• Anything Not Requiring Medic or Bulky
Equipment!
– Drug Administration
• Tablet counts, injections, infusions,
compliance & accountability
– Blood Sampling
• Centrifuging, Courier collection,
POC devices
– Efficacy assessments
– Safety assessments
– QOL, Health Economics
– ECG
© Medical Research Network 2007 www.themrn.co.uk

10. What Can Be Done In The Home
• Ideal Protocols
– Multiple Repetitive Visits
• Safety Bloods
• Infusions
– Subject Population
• Elderly
• Immobile
• Working
– Geography
• Increases catchment
• Potential Decrease Sites
© Medical Research Network 2007 www.themrn.co.uk

11. Service Set Up
– Nursing Manuals
• Detailed Home Care Instructions
• Source Documents
• Training Material
– Team Collation
• Per Study, Per Country
• Patient Dependent
• Just in Time Trained
– F2F, Webex
– Protocol
– Assessments
– ICH
– SAEs
© Medical Research Network 2007 www.themrn.co.uk

12. How Does It Work
• Site ID & Consent Patient
» Site Complete
CRF
Site Refer Patient to
Home Care Provider
Source
Document Completed
Nurse Completes
Visit In Home
© Medical Research Network 2007 www.themrn.co.uk

13. How Does It Work
• Site ID & Consent Patient
» Site Review
» Data
Site Refer Patient to
Home Care Provider
Data Recorded Via
Digital Pen
Nurse Completes
Visit In Home
© Medical Research Network 2007 www.themrn.co.uk

14. Factors Influencing Patients
The Protocol & Study Design
• The Site Staff & Facilities
© Medical Research Network 2007 www.themrn.co.uk

15. Factors Influencing Patients
• Site Staff
– Availability & Time
• Who is doing what – Who will you see
• When - Flexibility
• For how long – Speed of visit
• Patient Identification
– Knowledge
• Protocol – To conduct visits
• IB – Safety issues
• PIS – To explain the trial
– Interest
• Are they motivated
© Medical Research Network 2007 www.themrn.co.uk

16. What Can We Do? – Site Staff
• Increase Time Assessing Resource
– Patient Numbers - Qualified
– Review Inclusion Criteria
– Patient Numbers
– Assessments & Time
– Staff Availability & Experience
• Responsibilities
– Patient Numbers
– Clinic Space & Facilities
– Patient Numbers
© Medical Research Network 2007 www.themrn.co.uk

17. What Can We Do? – Site Staff
• Outcome ... Terrible PI, No Patients
– Drop Site!
• Outcome ... Good PI, Loads Patients ...
– Inadequate Resource
• Research Nurse
• Recruitment Nurse
• Infusion Nurse
• CTA – Data Transcription
– Consider Home Care
• Reduce On site Nurse & Clinic Time
© Medical Research Network 2007 www.themrn.co.uk

18. Contingency Planning
• Plans to Fix Problems ... When They Occur
– Increase Sites
– Increase Visits – PM, Sponsor
– Increase Countries
– Review Protocol & Issues
– Add in Site Resource
– Consider Homecare options
© Medical Research Network 2007 www.themrn.co.uk

19. Contingency
Standard approach
Site resources identified
as poor
Poor recruiting sites start to
C D perform, but costs ‘add on’ to
original budget
Site set
Protocol Site ID Recruit Recruit Recruit Recruit RX RX
up
A B
Recruitment
HTS set up
appears
2 to 4 months
difficult
Slow studies start to perform, but costs
‘add on’ to original budget
© Medical Research Network 2007 www.themrn.co.uk

20. To Quote ...
• Murphy’s Law
– "Anything that can go wrong will go wrong.”
• Finagle’s Law
– "Whatever can go wrong will go wrong, and at
the worst possible time, in the worst possible
way."
© Medical Research Network 2007 www.themrn.co.uk

21. The Facts ...
Development Costs ($Billions)
1.6
1.4
1.2
1
0.8
0.6
0.4
0.2
0
1975 1987 2001 2006
• Phase II Trials Take 31% longer than planned; Phase III Trials 30%
• 85-95% of days lost are due to recruitment issues
© Medical Research Network 2007 www.themrn.co.uk

22. Prophylactic Contingency
Ideal approach
Site resources identified as poor
Sites have resources they need from
B C the start, recruit on time,
Cost Neutral
Site set
Protocol Site ID Recruit Recruit Recruit RX RX
up
A
Recruitment HTS set Cost neutral
appears difficult up Speed up by 25% (3 months)
1 to 3
months
© Medical Research Network 2007 www.themrn.co.uk

23. Additional Cost Benefit
Compound in Development for Treatment of Arthritis
Actual Hypothetical
~300 sites recruited 10 Select & Prepare
or fewer patients each Sites Better
450
Average Patients per Site: 14.9 Average Patients per Site: 23.3 (+56%*)
Number of Sites: 670 Number of Sites: 449
300
= Redistributed Sites
No. = Existing Sites
Sites
150
0
0–10 11-20 21-30 31-40 41-50 51-60 61-70 >70
Patients recruited / site
Selecting sites that recruit >10 patients requires 221 less sites
Cost savings @ $20K** / site = $4.42M.
© Medical Research Network 2007 www.themrn.co.uk

24. In Summary
• Patient’s Perception Is Critical To Success
– Keep It Simple
– Ensure Adequate & Appropriate Resource
– Take The Trial To The Patient
• Implement Strategy Early!
– Speed Up Recruitment
– Potentially Reduce Site Requirements
– Potentially Reduce Patient Numbers
– Offer Ultimate Cost Neutrality or Saving!
© Medical Research Network 2007 www.themrn.co.uk

25. Thank You!
Netherlands Germany
UNITED KINGDOM Belgium
Poland
Republic of Ireland
Hungary
Canada
France Czech Republic
USA
Portugal
Spain Thailand
Switzerland
Australia
Stuart Redding
Stuart.Redding@themrn.co.uk
+44 7764 965 039
The MRN Ltd - Global Site & Home Trial Support Specialists
© Medical Research Network 2007 www.themrn.co.uk