Evaluating the risk management strategies for patient ... the risk management strategies for patient...
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Evaluating the risk management strategies for patient recruitment to meet your timelines By Nikki Christison Project Manager, PSI CRO
Transcript of Evaluating the risk management strategies for patient ... the risk management strategies for patient...
Evaluating the risk management strategies for patient recruitment to meet your timelines
By Nikki Christison
Project Manager, PSI CRO
Slide 2
OBJECTIVES
Review the CROs rationale for site selection and recruitment goals to ID risk factors upfront and accurately
Discuss a strategic analysis of sites during the initiation stage to discover the sites potential for effective recruitment
Redefine the traditional site selection process and conventional recruitment forecasting to solve the patient recruitment conundrum
Assess best practices in patient recruitment to avoid study delays
Slide 3
POOR PATIENT ENROLLMENT IS
THE INDUSTRY‘S BIGGEST
PROBLEM
85% of trials are behind schedule and the main reason is slow enrollment (CenterWatch)
Possible reasons
Investigators, Project Managers, or Senior Management, are not realistic about patient enrollment at the study start
Competition is fierce and many indications are getting even more saturated with clinical trials
We don’t select the right sites
Slide 4
CLINICAL TRIAL PARTICIPATION RATES
Ranges from 4-12% of eligible patient populations despite a nearly doubling of industry spending on patient recruitment which rose from $275 million in 2000 to more than $530 million in 2004.
Source: Parexel’s Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008
Slide 5
TYPICAL SITE RECRUITMENT PATTERN
Sources: Tufts CSDD, 2007; McKinsey & Company, 2004
30%
30%
20%
20%
Slide 6
WHAT CHALLENGES ARE THERE
Sites
Start-up
Protocol Poorly Designed or
Challenging Protocol
Poorly Designed Contracts/Proposal
under scope or budget
Protocol Amendments
Poor Feasibility Unrealistic Timelines
Costly change orders
Delay in study start or enrollment
Slow Enrollment
Slide 7
IMPACT OF CURRENT STATE
90% of studies fail to meet enrollment targets
20% of sites fail to enroll one patient
Only 7% of sites deliver what they say
So how do we increase that 7% to 95%?
Source: Tufts CSDD, 2010
Slide 8
TIME FOR CHANGE
Investing in a proper assessment at the start pays big
dividends later in both time and money
The key is to obtain a real-world assessment without
paying the real-world price of midcourse delays and
corrections during the study
Feasibility assessment is more than an opportunity to
determine whether a study is, or is not, feasible. It is
also an opportunity to make infeasible studies feasible
and to make feasible studies even more successful.
Slide 9
WHAT DOES THE SPONSOR NEED
TO DO?
Determine study start date and work backwards to determine RFP timelines and protocol development
Develop detailed protocol (or synopsis)- early enough to allow site “buy in”
Contact potential vendors Meet with short list and require key members of proposed team participate
Discuss experience, feasibility, enrollment estimates, competing studies, SOC, assumptions, budget (what is and is not included)
Agree timelines, scope and budget with CRO and communicate them to all interested parties
Ensure that Sponsor meets deliverable timelines – protocol, IB, manufacturing, sub-contractors etc.
Help define the feasibility process and expectations !!!
Slide 10
WHAT DOES THE CRO NEED TO
DO?
Invest time and resource in proposal process Feasibility, feasibility, feasibility
Pressure test assumptions- real world evaluations
Proposal/budget detail and accuracy
Buy-in and accountability from Project Team
Discuss and defend proposal with client- how sites are assessed for real world deliverables
Include time for detailed site evaluation and development of appropriate process
Deliver
Slide 11
ADDRESSING RECRUITMENT
Identify the number of
patients needed at a
site in order to meet
the target enrollment
and subject
completion
So, what is the
formula???
CPP, Inc.
Slide 12
RECRUITMENT CHALLENGES- ROOT CAUSE ANALYSIS
Prevent the Problem!
Fix the Problem- Address the Cause
Identify the Problem- Ask Why
Slide 13
WHAT KIND OF SITES DO WE WANT?
13
Investigator Interest , Capability & Willingness
Hi Low
Availability & Enrollability of
Patient Population
Hi
Low
Higher likelihood of success
May be able to support with training, resources, recruitment assistance, etc.
Will be harder to engage but may be able to leverage available patients
All the resources, motivational efforts, and support will likely not yield expected results
CPP, Inc.© 2009
Slide 14
FEASIBILITY GUIDELINES
Who
What
When
How
Slide 15
WHO
Design the questionnaire to obtain participation from key members of the study team.
Ask the investigator, study coordinator, pharmacist, etc., to answer questions that pertain to their expertise.
Carefully pre-screen sites- sponsor recommendations, CRO recommendations, other sources
Communicate (truthfully) to sites that they have been carefully pre-screened, so their input is extremely valuable
Slide 16
ASK THE RIGHT QUESTIONS
Ask the “right” question
Of the “right” people
In the “right” way
At the “right” time
Slide 17
WHAT
Provide sites with adequate information to perform a thorough feasibility analysis, focusing on red flags, must-haves, and potential operational issues.
Include open-ended questions that help sites think through the issues
e.g. “Given the geriatric study population, how will you contact them about the study?” and “What, if anything, excites you about this study?”
Slide 18
WHEN
Give sites adequate time to complete a thorough feasibility assessment, including an enrollment validation assessment
Ask for real numbers to support their enrollment predictions (consider including small stipend in the budget to support site time)
Current database
Performance of previous studies
ICH GCP 4.2.1
Slide 19
HOW
Consider compensating sites for: conducting a database review/chart review assessment contacting a few likely subjects, to confirm enrollment potential
Encourage sites to review previous, similar studies especially comparing their feasibility assessments to their actual performance and give the reasons for any shortfalls
Encourage sites to “just say no” if the study is not a good fit, preferably with some explanation and suggestions.
Train promising sites in how to conduct feasibility assessments to make better informed study selection decisions
Avoid checklist questions in the questionnaire
Slide 20 20 CPP, Inc. © 2009
Slide 21
SUMMARY
CROs rationale for site selection and recruitment goals to ID risk factors upfront and accurately
Determine the minimum number of patients needed to meet enrollment
Conduct RCA for identified challenges- Address the cause, not the result
Strategic analysis of sites during the initiation stage to discover the sites potential for effective recruitment
ICH GCP 4.2.1
Redefine the traditional site selection process and conventional recruitment forecasting to solve the patient recruitment conundrum
Feasibility Approaches- who, what, when, how
Assess best practices in patient recruitment to avoid study delays
Realistic goals
“Fill the funnel”
