Accrual StrategiesAccrual Strategies

The enrollment of study subjectsThe enrollment of study subjects

Presented byPresented byLena Marra ,MA HADLena Marra ,MA HADDirector of ResearchDirector of Research

Department of RadiologyDepartment of Radiology

Successful recruitment of participants for any Successful recruitment of participants for any clinical trial is a challenge.clinical trial is a challenge.

The majority of clinical trials are delayed due The majority of clinical trials are delayed due to low enrollment that can result in lost to low enrollment that can result in lost revenue.revenue.

The enrollment of subjects for your clinical The enrollment of subjects for your clinical trial is one of the most difficult and rate-trial is one of the most difficult and rate-limiting step for all studies.limiting step for all studies.

Steps to examine before Steps to examine before committing to a trialcommitting to a trial

Develop an understanding of the population being recruitedDevelop an understanding of the population being recruited Master a clear insight of the inclusion/exclusion criteriaMaster a clear insight of the inclusion/exclusion criteria Seek collaboration from other colleagues and commit to Seek collaboration from other colleagues and commit to

building a close working relationshipbuilding a close working relationship Make sure that the PI and staff can commit the time Make sure that the PI and staff can commit the time

needed to devote to the projectneeded to devote to the project Adhere to the mandates of NIH-sponsored research in the Adhere to the mandates of NIH-sponsored research in the

recruitment of under-represented populationsrecruitment of under-represented populations Be aware of the evolving HIPAA regulations of directly Be aware of the evolving HIPAA regulations of directly

contacting potential participantscontacting potential participants

Recruiting BasicsRecruiting Basics

Direct advertising represents the majority of Direct advertising represents the majority of recruitment tools used by investigators to recruitment tools used by investigators to identify potential research subjectsidentify potential research subjects

Subjects need to be given sufficient, and Subjects need to be given sufficient, and accurate information to make an informed accurate information to make an informed decision about their participation in a studydecision about their participation in a study

All subject recruitment materials must be All subject recruitment materials must be reviewed and approved by the IRB before reviewed and approved by the IRB before they are utilizedthey are utilized

Recruitment possibilitiesRecruitment possibilities

PI and Co-PI direct enrollmentPI and Co-PI direct enrollment Self-referralSelf-referral Radio/TVRadio/TV Printed materialPrinted material Direct mailDirect mail Internet Web sitesInternet Web sites Community OutreachCommunity Outreach Recruitment Advertising CompaniesRecruitment Advertising Companies

What makes a good advertisement?What makes a good advertisement?

Study descriptions should be written in plain language and easily understood Study descriptions should be written in plain language and easily understood by the general publicby the general public

Clearly state the condition or patient group under study and the purpose of the Clearly state the condition or patient group under study and the purpose of the trialtrial

The name of the investigator and the research facility should be visibleThe name of the investigator and the research facility should be visible

List contact numbers and e-mail if possible. Be certain the person answering List contact numbers and e-mail if possible. Be certain the person answering the phone is knowledgeable about the studythe phone is knowledgeable about the study

Be explicit about what is expected of participants Be explicit about what is expected of participants

Compensation should be stated without promise of benefit or inducement.Compensation should be stated without promise of benefit or inducement.

Flyers and brochures should be made available in different languages Flyers and brochures should be made available in different languages

To ensure subject retentionTo ensure subject retention

Schedule study visits at a convenient time Schedule study visits at a convenient time for subjectsfor subjects

Maintain close communication with subjects Maintain close communication with subjects and their familiesand their families

Return phone calls promptlyReturn phone calls promptly Explain compensation Explain compensation

SummarySummary

No single recruitment strategy may achieve No single recruitment strategy may achieve enrollment goals.enrollment goals.

The goal of any study should be to treat all The goal of any study should be to treat all volunteers in an ethical manner by volunteers in an ethical manner by respecting their decisions, protecting them respecting their decisions, protecting them from harm, and making every effort to from harm, and making every effort to secure their well-being.secure their well-being.