the trial site & beyond! stuart redding, the mrn ltd
TRANSCRIPT
w w w . t h e m r n . c o . u k
THE MEDICAL RESEARCH NETWORK A ‘Clinical Trial Support Organisation’ (CTSO)
The Trial Site & Beyond!
Stuart Redding, Director
w w w . t h e m r n . c o . u k© Medical Research Network 2007
The Trial Site & Beyond!
Feasibility …
What
When
Why
w w w . t h e m r n . c o . u k© Medical Research Network 2007
The Trial Site & Beyond!
Key Stakeholders in Patient Recruitment ...
Sponsor / CRO Investigator Patients
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
The Patient’s Perception
w w w . t h e m r n . c o . u k© Medical Research Network 2007
Factors Influencing Patients
The Protocol & Study Design
• The Site Staff & Facilities
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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%
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
Factors Influencing Patients
The Protocol & Study Design
• The Site Staff & Facilities
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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
w w w . t h e m r n . c o . u k© Medical Research Network 2007
Protocol Site IDSite set
upRecruit Recruit Recruit Recruit RXRX
HTS set up2 to 4 months
Recruitment appears difficult
A B
Slow studies start to perform, but costs ‘add on’ to original budget
Site resources identified as poor
C D
Standard approach
Poor recruiting sites start to perform, but costs ‘add on’ to
original budget
Contingency
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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."
w w w . t h e m r n . c o . u k© Medical Research Network 2007
The Facts ...
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1975 1987 2001 2006
Development Costs ($Billions)
• Phase II Trials Take 31% longer than planned; Phase III Trials 30%
• 85-95% of days lost are due to recruitment issues
w w w . t h e m r n . c o . u k© Medical Research Network 2007
Protocol Site IDSite set
upRecruit Recruit Recruit RXRX
HTS set up
1 to 3 months
Recruitment appears difficult
A
Site resources identified as poor
B C
Cost neutralSpeed up by 25% (3 months)
Ideal approach
Sites have resources they need from the start, recruit on time,
Cost Neutral
Prophylactic Contingency
w w w . t h e m r n . c o . u k© Medical Research Network 2007
Additional Cost Benefit
Compound in Development for Treatment of Arthritis
Selecting sites that recruit >10 patients requires 221 less sites
Cost savings @ $20K** / site = $4.42M.
Select & Prepare
Sites Better
Hypothetical
Average Patients per Site: 23.3 (+56%*)
Number of Sites: 449
= Existing Sites
= Redistributed SitesNo.
Sites
150
300
450
Patients recruited / site
0
0–10 11-20 21-30 31-40 41-50 51-60 61-70 >70
Actual
~300 sites recruited 10
or fewer patients each
Average Patients per Site: 14.9
Number of Sites: 670
w w w . t h e m r n . c o . u k© Medical Research Network 2007
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!
w w w . t h e m r n . c o . u k© Medical Research Network 2007
Thank You!
Australia
USA
Canada
UNITED KINGDOM
France
Germany
Belgium
Portugal
Poland
Netherlands
Republic of Ireland
Czech Republic
Switzerland
Spain
Hungary
Thailand
Stuart Redding
+44 7764 965 039
The MRN Ltd - Global Site & Home Trial Support Specialists