• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Meeting Enrollment Goals in a Competitive Environment
 

Meeting Enrollment Goals in a Competitive Environment

on

  • 2,222 views

Challenges in patient recruitment continue to be the number one cause in clinical trial delays. Through involvement in this workshop, participants will become familiar with how to develop, implement, ...

Challenges in patient recruitment continue to be the number one cause in clinical trial delays. Through involvement in this workshop, participants will become familiar with how to develop, implement, manage and track site enrollment plans. This will include understanding the core elements that constitute an enrollment plan as well as understanding how the development of strategic tools and tactics can aid sites in the successful implementation, monitoring and tracking of results. Both project management and site perspectives on enrollment and recruitment plans will be discussed.

Statistics

Views

Total Views
2,222
Views on SlideShare
2,221
Embed Views
1

Actions

Likes
0
Downloads
20
Comments
0

1 Embed 1

http://health.medicbd.com 1

Accessibility

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    Meeting Enrollment Goals in a Competitive Environment Meeting Enrollment Goals in a Competitive Environment Presentation Transcript

    • Meeting Enrollment Goals in a Competitive Environment: Development, Implementation & Monitoring of Site Patient Recruitment & Enrollment Plans Presenter Jacqueline Zarro, Ph.D. Vice President Clinical Project Management - US Premier Research Group Limited United States
    • Disclaimer • The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. • These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 46th Annual Meeting Washington, DC - 2010 2
    • Topics • Basis for Meeting Enrollment Goals – Foundation and Tools • Recruitment and Enrollment Plan – Site Specific • Maximize Enrollment – Tracking and Additional Tools 46th Annual Meeting Washington, DC - 2010 3
    • Enrollment Statistics Statistics show most clinical trial delays are a result of poor enrollment: • More than 70% of U.S. and 55% of European clinical sites reported delays of more than one month beyond contracted enrollment timelines • Only 7% of U.S. and 18% of European sites reported meeting enrollment timelines (U.S. down from 10% in 2005) • Delays also occurring at high rates in other regions of the world * 2007 CenterWatch Survey Results 46th Annual Meeting Washington, DC - 2010 4
    • Basis for Meeting Enrollment Goals: Foundation to Enrollment Success Regular review Status updates Roll-out of enrollment plan Communication Study enrollment planning Inclusive site qualification Feasibility Thorough site feasibility 46th Annual Meeting Washington, DC - 2010 5
    • Basis for Meeting Enrollment Goals: Tools Single Site Feasibility Study Specific Site Enrollment Enrollment Study Analysis Qualification Target Plan Enrollment Plan 46th Annual Meeting Washington, DC - 2010 6
    • Recruitment and Enrollment Plan: Single Site Specific Study Enrollment Plan 46th Annual Meeting Washington, DC - 2010 7
    • Recruitment and Enrollment: Site Specific Plan Definition • Template tailored to indication, study design • Includes recruitment resources / approach and targets for enrollment • Written hard-copy document • Site specific • „Agreement‟ signed by site staff 46th Annual Meeting Washington, DC - 2010 8
    • Recruitment and Enrollment Plan: Site Specific Plan Content • Site‟s: – Enrollment target – Timeframe – Recruitment sources • E.g.: database, advertising, referrals, outreach – Subject identification activity to date – Barriers to recruitment and enrollment 46th Annual Meeting Washington, DC - 2010 9
    • Recruitment and Enrollment Plan: Site Specific Plan Implementation Ongoing Communication Template Tailored to be Signed by developed Review site specific PI and SC by PM 46th Annual Meeting Washington, DC - 2010 10
    • Recruitment and Enrollment Plan: Site Specific Plan Implementation • Sample template plan, tailored by Site Study enrollment expectations Site enrollment expectations 46th Annual Meeting Washington, DC - 2010 11
    • Recruitment and Enrollment Plan: Site Specific Plan Implementation • Proactive identification of pitfalls • Signed by PI and Study Coordinator Identification and review of challenges to enrollment • Past study challenges Recruitment • Challenges unique to current protocol challenges • Creative approaches to proactively addressing Site signatures 46th Annual Meeting Washington, DC - 2010 12
    • Maximize Meeting Enrollment Goals: Tracking Cumulative Enrollment Graph 450 Number of Patients Enrolled 400 350 300 250 200 150 100 50 0 Projected Enrollment per Plan Actual Patients Enrolled 46th Annual Meeting Washington, DC - 2010 13
    • Maximize Meeting Enrollment Goals: Additional Tools • Study Coordinator teleconferences • Outreach – Advertising • Flyers/brochures in office – Local resources • Health Fairs • Community Groups – Hospital / health community newsletters – Clinical study postings on websites 46th Annual Meeting Washington, DC - 2010 14
    • Maximize Meeting Enrollment Goals: Additional Tools • On-going communication – Regular site calls (e.g., weekly, bi-weekly) • Scripted and non-scripted dialogue – Site teleconferences – Enrollment metrics • Screened, enrolled completers – Projected – Actual – Total active / eligible sites 46th Annual Meeting Washington, DC - 2010 15
    • Conclusions • Proactive approach – Thorough site feasibility and qualification • Enrollment plan – Introduction, development of study-specific template; implementation of individualized plans • On-going review of plan and tracking • Maximize knowledge and creativity • Contingency planning 46th Annual Meeting Washington, DC - 2010 16