Embed Size (px)
DESCRIPTION
For years, compounding pharmacists have specialized in customizing medications when mass-produced products just won’t do. This personalized approach to treatment requires therapeutic understanding, deep and relevant experience, and the flexibility to adapt clinical formulas for success. Likewise, as clinical trial protocols become more complex and targeted, the industry is discovering that cookie-cutter strategies for finding and supporting investigative sites with patient recruitment are insufficient. Topics Include: Leveraging big data to identify sites with the highest probability of enrollment success Applying a recruitment mindset to the site feasibility questionnaire and interview process Developing and nurturing strong relationships with investigators and study coordinators to improve enthusiasm and dedication to enrollment excellence FOR MORE INFORMATION, VISIT WWW.IMPERIALCRS.COM
Citation preview
Site Performance Compounding: Finding the
Right Formula for Planning to Prevent Poor
Patient Enrollment at Investigative Sites
Dan McDonald
DAC Patient Recruitment Services
August 12, 2014
1
Question & Answer
• We will be using the chat feature for question and answer.
• During the presentation, please type in your question in the chat box at that bottom of the control panel on the right hand side of the screen.
• At the conclusion of the presentation, Dan will answer your questions.
2
3
Speaker Introduction
Dan works from DAC’s Boston office identifying income opportunities, building strategic
partnerships, and managing contract negotiations. He re-joined the team in 2013, having previously served in the area of strategic and business development under DAC’s former brand moniker, D. Anderson & Company, from 2006 to 2007. Dan has authored many articles for industry publications, is a popular presenter at industry conferences, and has conducted numerous workshops on patient recruitment for clinical trials.
4
Setting the
Stage
5
6
When to
Plan?
Answer – At Inception
7
What can go wrong, very well may without proper planning (which includes contingencies)!!!
Unreasonable and under-vetted protocol design
Incomplete and/or inaccurate feasibility data
Patient pools dry up after study start
Poor communication channels with sites
Cultural differences and communication gaps
Lack of customized patient recruitment plan;
Lack of risk mitigation strategies
Scope and budget creep
Unmotivated or angry investigators
Delays, delays, delays
Sure, go ahead, leave it to chance!
Lions, Tigers & Bears ─ Oh My!
Protocols are designed to satisfy FDA scientific
requirements and advance science:
What about the reality of conducting the
study?
Does the target patient population exist?
Invite ―operators‖ to evaluate the protocol
Leverage ―big data‖ when available.
Who will be involved in the decision to
participate? Caregiver support required?
Protocol Design
9
66% of sites only conduct one study. Why?
What questions should we ask?
Openness; flexibility; attitude:
A Recruitment Mindset for the Feasibility Process
Responsiveness
Openness to Training
Willing to Implement Recruitment Procedures
Acceptance of Outside Support
A Recruitment Mindset for the Feasibility Process
• Ensure mix of KOLs with lesser-known, competent, enthusiastic PIs
• Consider location in a country:
• PI’s in Tier 2 and 3 cities often perform better
• Capture metrics on past performance for similar studies
• Ensure no participation in competing studies
• Determine catchment area around site and referral patterns
• Consider accessibility and convenience factors for subjects
Data-Driven Approaches Impactful Highest % Areas Are Red or Hot; Lowest Are Blue or Cold
12
Rank the best
geographic
areas based on
prevalence,
Patient
Definition
Raw
Patient Count (Insured, & Medicare)
Projected
Patient Count (All Patients, Inc.
Uninsured)
Investigator
Count (w/ Matching
Patients
Physician Count (w/ Matching Patients)
Cardio-
pulmonary
Bypass
4,498 62,789 369 1,564
Also…..
If a 3+ month lag occurs, re-
evaluate competitive
market and conduct a 2nd,
small scale feasibility with
previously selected sites.
Minimize lag time
between site feasibility,
investigator meeting and
study initiation.
14
Enroll within 90+ days <10% chance of success
Enroll within 60 days 50% chance of success
Enroll within 30 days 90%+ chance of success
Typically, Enrollment Timelines Drive Success
Answer – A plan
15
What to Plan?
Critical to develop expertise with regards to the recruitment landscape
Consider developing a proactive recruitment plan for each site
The ways in which patients can be engaged at the investigative site
Which types of initiatives prove successful when supporting sites
Typical utilization rates for the various recruitment strategies by sites
Which recruitment materials require EC approval & approval timelines
Understand how patients first learn about clinical trials
Identify common stakeholders in the consent decision process
Engage CRAs, as they provide a critical link with the investigative site
Involve local expertise and networks to cast a wider net
Patient Recruitment Planning
Plan upfront to utilize external
recruitment and/or retention support whether implemented or not.
Plan a Plan
17
“Success is when everything that goes wrong, fits in your plan.” ― Gary Rudz.”
Establish a line item for recruitment and retention in each study budget
Recruitment cost per patient: $1,500–$10,000+ (depending on factors)
Consider allocating 5% of site per patient grants for retention.
90% of sites have no formal plan/funds to address retention.
Increase allocation based on TA or long-term safety study.
Common Contingencies for Slow Enrollment
Hire new CRO
Addition of sites – avg. $20–$30K/site in the U.S.
Protocol amendments – avg. $1M/protocol
Extend timeline – avg.
Out of Pocket Costs: $100-150K (day)
Opportunity Costs: $1M (day)
Effective contingency planning requires proper support.
Contingency Planning
18
Answer – Listen
19
How to Engage
Sites in Your
Plan
Establish forums that allow CRCs to have a ―voice.‖
Study-specific trainings
Face-to-face
Web conference
Advisory committee
CRCs are their own best advocates.
Engaging CRCs has a proven direct impact on
lagging enrollment.
20
CRCs are the Backbone of Sites – Give Them a Voice!
Consider Factors for Strong Investigator Relations
Proactively address investigator concerns with protocol.
Consider need for local representation.
CTAs should be milestone driven.
Ensure fair allocation of site grant to PI.
Be sensitive to regional compensation differences.
In-person sponsor visits have many benefits.
Consider critical site support personal availability.
Determine availability of onsite CRC or through contract.
Be wary of investigator leveraging and strong-arming.
Set aside funds for investigator recognition.
Consider mid-study rejuvenation meetings.
Have backup sites contracted, approved and ready.
It’s 2014– Investigators the world over can easily communicate with each other and often do. Avoid unfair and unjustified compensation differences
Answer – Planning!
22
Planning vs….
That Other
Thing
After six months, enrollment is lagging.
Decision is made to amend the
protocol and replace 30 sites.
Amended protocol cost estimate = $1M
Site replacement cost = $900K
Total amended project cost — $11.9M
(19% budget increase)
Rescue Costing Scenario
23
After six months, enrollment is lagging.
Decision made to add a centralized
recruitment campaign:
Start-up timeline (2–3 months)
Costs of delays for program
implementation (~$250K)
Recruitment campaign — $1M
Total amended project cost — $11.3M
(13% budget increase)
Rescue Costing Scenario
24
Implement a proactive
recruitment program
Recruitment campaign — $500K
Total amended project cost —
$10.5M (5% budget increase)
Proactive Costing Scenario
25
Rescue
Total amended project cost — $11.9M
(19% budget increase)
Total amended project cost — $11.3M
(13% budget increase)
Proactive
Total amended project cost — $10.5M
(5% budget increase)
Cost savings with PROACTIVE planning
160%–280%
Proactive vs. Rescue Cost Savings
26
Consider expanding your protocol review team.
Apply a recruitment mindset to the feasibility process.
Sites are a critical partner in the success of your study – treat them like it.
If nothing else, develop a proactive recruitment and/or retention plan.
Establish recruitment/retention line items in your study budgets.
Follow-through
And, enjoy study success!!!
In Summary….
27
Rescue Training Can Jumpstart Enrollment…..
78 Sites Attended August Meeting or Webinar
42 Sites have Pre-Screened 82 Patients
28 Sites Consented 38 Patients
19 Sites have Randomized 24 Patients
29
Expected Randomization as of December 2, 2013 = 43
Actual Randomization as of December 2, 2013 = 65 – A 51% increase over expected!!
Investment - $6,175 vs. rescue = 300% cost savings and enrollment is ahead of schedule!
30
Study Enrollment
…But, Proactive Training Can Ensure that Projected
Enrollment Timelines are Achieved or Exceeded
