UCSF Participant Recruitment Service: Preparing for Launch!
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Transcript of UCSF Participant Recruitment Service: Preparing for Launch!
PRS – Preparing for Launch
Nariman A. Nasser, DirectorParticipant Recruitment Service
Clinical & Translational Science InstituteUniversity of California, San Francisco
AGENDA Participant Recruitment in the Clinical
Research Paradigm
Addressing the Needs
Participant Recruitment Service Model
Preparing for Launch
Poor Recruitment Experience• Lack of Momentu
m
• Forgotten Study
Procedures
• Data Deficiencies /
Loss of Integrity
• Breach of Ethics
• Inconclusive Study
Outcome
• Fewer Publications
• Reduced Funding /
Sponsorship
Challenges
Coordinators have limited time and are not properly equipped to conduct recruitment
Recruitment efforts across units, departments and institutions are uncoordinated and costly
More than 80% of clinical trials are delayed due to recruitment
Lack of diversity in clinical trials can lead to disparities in effectiveness in the marketplace
Create a centralized service to facilitate the enrollment of research participants into UCSF clinical studies
Assume a large part of the burden of recruitment efforts
Provide expertise in recruitment materials development
Ensure materials meet regulatory guidelines and requirements
Offer an economy of scale for many recruitment activities
Use established vendor relationships
Increase the volume of high quality volunteers
Facilitate a wider catchment and more robust networks
Soft Launch Q2 2011
1. Recruitment Materials Toolkit
2. Pilot Recruitment Services (4 studies)
3. Pilot Participant Registry
4. Pilot Passive Database Recruitment???
Recruitment Materials Toolkit
Professionally developed by graphic designer
CHR pre-approved with accompanying guidance
Accessible from PRS Virtual Home at no cost
Printable via Documents, Media & Mail portalLink to CTSI-branded DMM portal from VHSelection of 5 designs with custom color palettesUse fund/dpa for payment direct to DMM
Recruitment Materials Collateral
Poster
Postcard
Brochure
Newspaper advertisement
Referring Health Care Professional Notice
Design selection accommodate a wide variety of clinical studiesObservational/non-interventional studyInterventional clinical trialPediatric study or clinical trial
Pilot Recruitment ServicesChemotherapy-induced neuropathy
PI: C Miaskowski, Dean SON N=600 (200 non-neuropathy) post-chemotherapy Longitudinal, QOL with genetics, single study visit Sizable recruitment budget, includes major media
Anticoagulation therapy dosing – Warfarin PI: M Fang, Anticoagulation clinic director N= 117, 19 enrolled after 11 months Dosing of warfarin by genetic marker vs. weight No recruitment budget, part-time coordinator
Pilot Recruitment ServicesAzithromycin to Prevent LRI
PI: M Cabana, Chief General Pediatrics N= 67, 12-71 months old, recurrent wheezing Lots of exclusion criteria
Vitamin D in Asthma PI: H Boushey, Chief Allergy & Immunology N= 125, vitamin-D deficient asthmatics Placebo-controlled Phase III efficacy Sophisticated research group with resources
Pilot Services
Experienced recruitment specialists provide:Analysis of past & current recruitment methods,
degree of success and associated costsFull cohort/competing study/recruitment analysis and
recruitment planRecruitment plan implementation
Call center (internal & external) Study-specific advertising & presentation materials Ad placement OmniScience mobile partnership
Study-specific recruitment metrics and tools
Pilot Participant Registry
Database of potential research participants who have actively registered
Includes brief health history
Excellent source of “healthy” volunteers
Developed on SalesForce platform
Populated from 2 sources Study-specific advertisements for pilot services
studies Mailing list from existing research volunteer
databases
Pilot Passive Database Recruitment
• Source = Integrated Data Repository (IDR)
• “Passive” waiver of consent on admission
• Use ICD-9 codes, Rx, demographics to identify aggregate cohorts
• PRS will act as HIPPA broker to obtain de-identified data and contact information
• Contact potential participants via letter