Identifying High Performing Sites and Engaging Patients
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One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
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Identifying High Performing Sites and Engaging Patients
- 1. IDENTIFYING HIGH-PERFORMING SITES AND ENGAGING PATIENTS WELCOME TO THE WEBINAR
- 2. M A K I N G T H E C O M P L E X S E A M L E S S • Patient recruitment challenges • Using data sources for recruitment • Identifying and engaging the right sites • Effectively supporting patients AGENDA 2
- 4. M A K I N G T H E C O M P L E X S E A M L E S S THE CHALLENGE 4 CISCRP http://medrio.com/partners/wp-content/uploads/2015/11/Clinical-Trial- Awareness-968px.png
- 5. M A K I N G T H E C O M P L E X S E A M L E S S REASONS ENROLLMENT LAGS AT A SITE • Protocol too restrictive • PI and/or Study Coordinator not engaged • Within practice ‒ Too few patients ‒ Competing trials ‒ Do not know how to disseminate protocol knowledge across practice including satellites ‒ Not enough staff • Going outside practice ‒ Referrals are rare ‒ Sites do not have the resources, time or skills to market direct to patients effectively 5
- 6. M A K I N G T H E C O M P L E X S E A M L E S S The Leaky Pipe 6
- 7. M A K I N G T H E C O M P L E X S E A M L E S S DEDICATED RECRUITMENT AND RETENTION PLAN FASTER ENROLLMENT WITH FEWER DROPOUTS Strategic management Data-driven – experience refined Preferred sites Patient centricity Recruitment and retention tools Vendor Partnerships Develop strategies and support the clinical operations team Use of internal and external data Identify top performing sites for faster study start up and enrollment Enroll engaged patients for greater patient satisfaction Customized plans for each study Advertising, social media, big data partners, etc. 7
- 8. USING DATA SOURCES FOR RECRUITMENT
- 9. M A K I N G T H E C O M P L E X S E A M L E S S Refined, data-driven approach to align a target population with motivated and experienced Investigators to create a precise and effective recruitment strategy PATIENT RECRUITMENT STRATEGY DATA-DRIVEN. EXPERIENCE REFINED. 9
- 10. M A K I N G T H E C O M P L E X S E A M L E S S DATA DRIVEN EXTERNAL AND INTERNAL DATA SOURCES • Optimize external data: Use global health research platforms that offer ‒ Investigator insights ‒ Studies details ‒ Access to patient lives • Use internal sources: ‒ Clinical study history ‒ Central laboratories ‒ Electronic Data Collection ‒ Imaging core labs • Standard of care, country-specific regulatory, cultural considerations • Prior site performance in the indication – Internal – External • KOL and Investigator relationships 10
- 11. M A K I N G T H E C O M P L E X S E A M L E S S US and European maps illustrating the prevalence of the indication, with overlying heat maps based on global health platform data. EXPERIENCE CUTS THROUGH DATA LIMITATIONS EXAMPLE SCENARIO 11 Step 1: Heat maps based on epidemiological and global health data
- 12. M A K I N G T H E C O M P L E X S E A M L E S S EXPERIENCE CUTS THROUGH DATA LIMITATIONS EXAMPLE SCENARIO 12 Step 2: Data analysis provides a more precise localization of high-performing sites (gold cylinders) Close-ups maps illustrating site distribution. • Each cylinder indicates a site which has participated in a previous study in the indication, with height representing the number of studies. • Gold cylinders represent high performing sites in previous studies.
- 13. IDENTIFYING AND ENGAGING THE RIGHT SITES
- 14. M A K I N G T H E C O M P L E X S E A M L E S S • Identifying the right sites is critical to achieving overall study start-up and enrollment goals ‒ Feasibility is a critical touch point to assess a site’s ability to enroll the intended patient population. The feasibility questionnaire should be specific and well targeted ‒ Site’s responsiveness during the feasibility process is a good indicator of future dedication to trial success ‒ Qualification visits are key to ensure a site is able to conduct the trial as outlined in the protocol • Leveraging long-term site relationships will foster a more collaborative and engaging trial experience • Ensuring sites recruitment efforts are well supported allows them to focus efforts on identification and enrollment of the targeted patient population SITE SELECTION AND ENGAGEMENT BOLSTERING RECRUITMENT FOR FASTER ENROLLMENT 14
- 15. M A K I N G T H E C O M P L E X S E A M L E S S • Build a strong RAPPORT with study sites and referral sources • Serve as an EXTENSION of the site staff ‒ COLLABORATE to ensure that strategies are accepted and implemented ALLEVIATING BURDENS on staff and keep sites FOCUSED on enrollment SITE ENGAGEMENT STRATEGIES BOLSTER SITES’ RECRUITMENT EFFORTS TO MAXIMIZE ENROLLMENT AND MEET STUDY GOALS 15
- 16. M A K I N G T H E C O M P L E X S E A M L E S S PREFERRED SITES ADVANTAGES • Consider a program that strategically aligns your top performing sites • Benefits include: ‒ Dedicated contact that will focus on your studies ‒ Real-time feedback • Protocol development and study design • Recruitment and retention methods ‒ Strengthens your relationship for future study opportunities ‒ Typically first sites to be activated 16
- 17. M A K I N G T H E C O M P L E X S E A M L E S S PREFERRED SITE PROGRAM GOALS • Develop relationships with elite sites • Provide quality feedback for preliminary feasibility • Expedite start-up and enrollment timelines • Ensure fast and consistent enrollment • Produce high quality data 17
- 18. M A K I N G T H E C O M P L E X S E A M L E S S SITE NETWORKS GOALS • Similar to Preferred Site Program: ‒ Strategic relationships with site networks strengthen your capability to deliver study patients • Build trust and mutual professional respect within the networks for a seamless and effective study start-up process ‒ Put MSA in place to expedite the feasibility and contracting phase ‒ Understand the network’s operations model • Central contracting • Central logistics • Preferred networks are those that have sites in a variety of indications and can start up quickly • Consider monthly meetings with preferred network liaisons to discuss study needs and upcoming work 18
- 19. M A K I N G T H E C O M P L E X S E A M L E S S CASE STUDY EXAMPLE: SITE ENGAGEMENT FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY 19 Patients unknown to site staff, and therefore limited medical history of patient before scheduling screening visit Difficult I/E criteria, specifically the muscle strength required of the patient for enrollment Number of visits and study commitment RECRUITMENT CHALLENGES
- 20. M A K I N G T H E C O M P L E X S E A M L E S S STUDY ENROLLMENT 20
- 21. M A K I N G T H E C O M P L E X S E A M L E S S KEY TAKEAWAYS 21 Enrollment goal met earlier than projected Average Screens July – October 11.25/Month Average Screens April – June 7.5/Month
- 23. M A K I N G T H E C O M P L E X S E A M L E S S PROTOCOL DEVELOPMENT PATIENT-FOCUSED STRATEGIES Patient Advocates Understand the Patient Select the Right Tools Relationships can be key to success Engaged patients – fewer protocol amendments Higher recruitment and retention 23
- 24. M A K I N G T H E C O M P L E X S E A M L E S S FORMING LASTING PARTNERSHIPS RELATIONSHIPS MATTER • Early engagement increases likelihood of developing true partnerships • Ensure opinions and shared experiences are being heard in the development of new therapies • Actively engaged in protocol review ‒ Power of their voice • Examples of study awareness opportunities: ‒ Website listing on advocacy group websites ‒ Newsletter placements, informing members of the study ‒ Patient email blasts from advocacy group membership list ‒ Other "outside the box" places that the study population may be found and study information can be shared 24 Patient Advocates Relationships can be key to success
- 25. M A K I N G T H E C O M P L E X S E A M L E S S • Why should patients consider trial participation? ‒ Seek patient/caregiver buy-in by clearly stating why your clinical trial is their best option ‒ Listen to their questions and make sure they feel as if their voices are being heard • Don’t be afraid to use social influences to get your message to patients. This includes Facebook posts, blogs, articles and paid and free promotion KNOW THE KEY DRIVERS FOR THE PATIENT POPULATION ENGAGING PATIENTS EFFECTIVELY 25 Understand the Patient Engaged patients – fewer protocol amendments
- 26. M A K I N G T H E C O M P L E X S E A M L E S S ENGAGING PATIENTS IS MORE THAN JUST MATERIALS • Be pro-active, Create a plan to minimize risk of enrollment lagging and retention issues • Incorporate additional patient engagement strategies • Digital strategies such as online media and social media advertising • Training videos on protocol requirements • Participation support initiatives 26
- 27. M A K I N G T H E C O M P L E X S E A M L E S S PATIENT ENGAGEMENT OUTREACH • Network with key influencers and advocates within the community • Educate patient and/or caregiver support groups • Canvas community for additional venues to contact • Distribute and display study materials • Liaise at local therapeutic/community health presentations and events • Opportunities for coverage in local regular publications, newsletters, web sites, etc. 27 Raise Community Awareness Engage Referral Networks Optimize Sites Select the Right Tools Higher recruitment and retention
- 28. M A K I N G T H E C O M P L E X S E A M L E S S PATIENT RETENTION • Providing patient and caregivers with the appropriate support is critical for retention • Addressing needs such as travel and home health services eases the burden of study participation • Supplying items to sites which support long visits such as entertainment tablets allows for a better patient experience • Acknowledging when patients achieve study milestones shows appreciation for their time commitment and reinvigorates their commitment to continued study participation 28 Mitigate participation obstacles Reinforce study participation Engaged patient/caregiver Select the Right Tools Higher recruitment and retention
- 29. M A K I N G T H E C O M P L E X S E A M L E S S KEY TAKEAWAYS • Power of data coupled with thoughtful recruitment strategies • Leveraging relationships • Patient-centric focus 29
- 30. TM
Editor's Notes
- CISCRP http://medrio.com/partners/wp-content/uploads/2015/11/Clinical-Trial-Awareness-968px.png
- Approver: Maiesha
- Approved: Gina Steidle 3-22-2019 Data alone can lead to spurious conclusions IntelliPACE overlays patient-level data with : Prior site performance Internal and external KOL and Investigator relationships Standard of care, country-specific regulatory, cultural considerations Aligns the target population with motivated and experienced Investigators
- Approved: Gina Steidle 3-22-2019 Global Health Research Platforms: access to public data and private global health research platforms providing information for over 400,000 investigators, across 300,000 studies, and involving more than 135 million patients, to supplement our internal metrics. Medidata TriNetX Citeline DataMonitor Clinical Study History: Our proprietary study management system, ClinTrak®, provides years of Investigator start-up, enrollment, and quality performance metrics to enable identification of high-quality, reliable sites Central Laboratories: a global repository of laboratory data drives sound recommendations relative to key inclusion/exclusion criteria to target investigators with the correct patient population Electronic Data Collection: a wealth of information regarding inclusion/exclusion criteria and their effect on enrollment in similar studies can help to inform study design and recruitment Imaging Core Labs: Assists with the identification of investigators in key therapeutic areas with access to specialized equipment and the experience required to conduct some of the most complicated studies currently designed
- Approved: Gina Steidle 3-22-2019 The maps illustrate a search for sites with previous experience in a single indication. As a first step, Medpace utilized both epidemiological and global health research platforms to understand the location of patients throughout the US and EU. The epidemiology data show a high prevalence of the disease by state/ region in the US and EU, whereas the heat maps indicate pockets of patients surrounding sites conducting research. However, these data, in the absence of site performance metrics, could lead to erroneous conclusions regarding placement of the study.
- Approved: Gina Steidle 3-22-2019 An analysis of site location indicates large numbers of sites that have conducted studies in the target indication. Overlaying performance data in prior clinical trials allows a more precise localization of high performing, quality sites (gold cylinders) relative to target population. These data highlight the importance of analyzing site performance on previous studies to effectively position the study with sites who are motivated to perform and have demonstrated prior success.
- Provides sites with a dedicated Site Relationship Coordinator (SRC), acting as a single point of contact concierge service Ensures sites are given high priority preference for all Medpace study feasibilities Access to our resources thus improving patient access to innovative and cutting edge clinical studies Offers enhanced management and support to help sites achieve success PI involvement with protocol development and study design Access to our wealth of experience and expertise, aiding in speedy and consistent patient enrollment Strengthens industry partnership and provides industry insight, otherwise not available Flagship Sites are typically first to be activated with some of the fastest industry timelines What specific Medpace resources are they getting that they wouldn’t receive from being a non-Flagship site? Sub-Is? Experienced CRCs? Is this different than #4 or could we maybe combine the two?
- Primary Objective: To develop vital relationships with lead sites, across the globe and to strengthen existing relationships with excelling sites, enabling us to deliver studies effectively to our Sponsors
- Calls conducted with sites 18JUN-26JUL Follow-up calls for targeted sites 26JUL-2AUG
- Gathering patient feedback during the protocol development phase from patient advocates is a key ingredient in ensuring the study needs are aligned with advocacy efforts Understanding the nuances of patient needs, especially in the development of the schedule of events, means a more engaged study participant and potential for less protocol amendments by addressing these needs upfront Identifying study specific awareness and educational tools includes thoughtful insight into what’s important to the study subjects will lead to higher recruitment and retention rate
- Patient advocates need to feel that their opinions and shared experiences are being heard in the development of new therapies. By engaging patient advocates upfront, the likelihood of developing true partnerships is increased. Effectively building relationships with patient advocates means they are actively engaged in protocol review. Modifying your protocol based on their feedback will lend itself to positive word of mouth about the study in patient communities and potential referral networks The list below is an example of potential study awareness opportunities that cans be available as a result of these partnerships: Website listing under the clinical trial section of the advocacy group's website Newsletter placements, informing members of the study Patient email blasts from advocacy group membership list, directing members to learn more about the clinical trial opportunity Other "outside the box" places that the study population may be found and study information can be shared
- It is important to identify why patients would consider trial participation. Understanding these motivating factors are key to building a successful engagement program Seek patient/Caregiver buy-in by clearing stating why your clinical trial is their best option Listen to their questions and make sure they feel as if their voices are being heard They are living with the condition and have to feel important in the decision making process Don’t be afraid to use social influences to get you message to patients. This includes Facebook posts, blogs, articles and paid and free promotion
- By utilizing Google AdWords to craft keyword-driven campaigns, sponsors, CROs, and investigator sites can reach a more targeted audience in a more cost effective manner than traditional recruitment channels like TV, radio, and print media allow for. Keep in mind that most patients today remain unaware that clinical trials are a viable treatment option, so keywords should relate to the specific condition and treatment, rather than clinical trials themselves. Avg 5+ hours/day on mobile device 62% users report searching for medical information on smartphone Facebook’s user base has reached more than two billion users, in some cases representing 100% of a given population for certain chronic or rare conditions, including Parkinson’s and Alzheimer’s disease. Moreover, patients are becoming increasingly comfortable using Facebook to talk about their health conditions or meet people in similar circumstances. Clinical trials can use Facebook’s unprecedented targeting capabilities to place ads in front of niche audiences. Whether they want to target based on age, race, gender, location, or even likes and dislikes, trials can ensure that their ads are only being shown to the right audiences at the right time. These ads are remarkably effective, too; Facebook’s ad response rate for clinical trials can be four to five times higher than banner ads on other platforms. REF - https://www.mdconnectinc.com/medical-marketing-insights/new-clinical-trial-patient-recruitment-best-practices-for-2018