Best Practices inClinical Study Recruitment

Nariman A. Nasser, DirectorParticipant Recruitment Service

AGENDA

Recruitment Practices

Retention Practices

UCSF Participant Recruitment Service

RECRUITMENT PRACTICES

Performing Initial Analyses

Study DesignSite-specific protocols for study-specific and SOC

proceduresPlacebo arms, excessive inclusion/exclusion criteria

Site-specificStaff resourcesLocation(s): accessibility, interoperability, features /

disadvantages

Competing Trials

Planning & Budgeting

Screen Failure Rate

Budget for the unexpectedDesign revisions Increased production & shipping costs over timeProtocol revisions impacting recruiting

methods/materials

Implementing the Plan

Staged approach

Multiple simultaneous advertising efforts

Plan on changing your plan – analyze relatively often

Communication PlanSponsor/Site StaffPrimary contactsSecondary contacts

Identify screening appointment schedule workflow, tools and conflicts

Ensuring High-Quality Participants

Start by casting a wide netThink about a wide number of things or people when choosing the

thing or person you want*

Don’t skip the prescreening step

Ask the right questions at the right stage of the recruitment process

*Idioms by The Free Dictionary

Monitoring Progress

Set realistic expectations up front

Identify benchmarks for success/failure

Simple tracking tools go a long way

Receiving logs & reports is not enough – they have to mean something and be actionable

Managing Enrollment Underperformance

Create competition among sites, coordinators and investigators to increase momentum and foster enthusiasm

Communicate underperformance before it becomes insurmountable

Be supportive in providing possible resources and solutions

Ensure nonperformance consequences are communicated prior to starting recruitment

Have a backup plan/resource

RETENTION PRACTICES

Ensuring Participants Are Well-Informed

Public opinion drives policy

Passionate advocates are essential“If you have more than 50

percent of patients saying their chances are better than

average of avoiding some harm or obtaining some benefit, they are being

unrealistically optimistic because you can’t say that

most people are above average.”

Parker-Hope, Patients with Unrealistic Expectations, The New York Times, March 7 2011

Understanding Participant Needs

Work/family obligations

Travel constraints

Financial incentives

Desire for information/sense of community

Expectations of coordinated care

Lack of insurance/comparison to SOC

Keeping Communication Open

Press releases

Local media

Patient newsletters

Direct patient/study staff communication via email or telephone

Post-study satisfaction surveys, newsletters, study drug updates

PARTICIPANT RECRUITMENT SERVICE

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

Recruitment Analysis and Planning

Robust recruitment planAnalysis of recruitment landscape

Protocol complexities, procedures, SOCCompeting studiesGeographic/demographic populationMarketing & Outreach methodologies

Suggested strategiesTimelinesBudgets for suggested strategies

Cohort ID and Direct Mail

Identify cohorts from inpatient medical records (UCare and ThREDS)ICD-9 codesDemographics

CHR modification

Coordinate data extract services from ARS

Print and mail direct mail letters to cohort

Other Resources

Research Participant Registry

Recruitment Materials Toolkit

Future Services/Resources

Recruitment Plan ImplementationCentralized call center, text messaging, online

screenersMarketing & outreachReferral networks

Searchable database of actively recruiting studies – matching

Real-time recruitment from EMR

THANK YOU