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

Clinical Research Conduct

• Protocol

• Recruit / Enroll

• Conduct Study Visits

• Analyze Data

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

PREPARING FOR LAUNCH

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

Full Launch 2012

• Searchable Listing of Recruiting

Studies

• Public Awareness Campaign

• Engage Patient Advocacy Groups & Establish Networks

• IDR Integration

• Recruitment Ethics &

Methodology Tools

• Full Recruitment

Services