RECRUITMENT STRATEGIESRECRUITMENT STRATEGIES: WAYS TO FACILITATE RESEARCHWAYS TO FACILITATE RESEARCH

PARTICIPANT ENROLLMENT AND

RETENTION

Rosleen Mansour, M.A.Research CoordinatorResearch CoordinatorDepartment of Psychiatry and Behavioral SciencesSeptember 25, 2012

RECRUITMENT ISSUESRECRUITMENT ISSUES (SOURCE: MARITHEA GOBERVILLE, PH.D) 

Patient recruitment is the leading barrier in conducting studies50% of sites enroll 1 or 0 patientsp6% of clinical trials are completed on time“Time to market” is key concern for sponsorTime to market  is key concern for sponsorCan cost up to $1 million/day for delays in tti d t k tgetting drug to market

STEP 1: STUDY DESIGN/REVIEW/CONTRACTSTEP 1: STUDY DESIGN/REVIEW/CONTRACTReviewing the protocol/contract: N=???What is the target enrollment?   

Expected recruitment rate? Maximum N, minimum N?

N

Multi‐site trials: Is enrollment competitive?

Will the study be terminated once enrollment met?

Ideal to have flexible target enrollment

What are the recruitment milestones/timelines?Target population: review of inclusion/exclusion criteriaWhat is the expected screening failure rate?What is the design of the study (e.g., Open Label vs. g y g pPlacebo‐controlled), risks, potential benefits?

SAMPLE CONSIDERATIONS (CPHS)SAMPLE CONSIDERATIONS (CPHS)Cultural diversity is strongly encouragedY li i l t i l l h ld b t ti fYour clinical trial sample should be representative of the local population affected by the condition in terms of: 

Ethnicity/RaceGenderAgeAge

Economically disadvantaged subjects: costs related to research should not preclude participation and p p pfinancial remuneration, reward, or reimbursement  for expenses must not be coercive to potential participantsparticipantsExclusion of a particular group may only be justified in certain cases (see CPHS Recruitment guidelines)

STEP 2: RECRUITMENT PLANSTEP 2: RECRUITMENT PLAN1. What strategies have been successful in the past?2. What resources do you need?2. What resources do you need?3. How will you recruit?

DatabasesApproaching existing patients in clinicAdvertising (tv, radio, newspaper)Sponsor referralsCommunity outreachExternal clinics/schools/facilitiesWebsites/internetAdvisory board/focus groups/surveys on patient sources and needs?

4. How will you ensure diversity? 5. When can you start to recruit??? What do you  need to accomplish before 

you can recruit?Contract/budgetIRBTrainingSite Initiation visitOrdering of supplies

6 Subject renumeration compensation reimbursement?6. Subject renumeration, compensation, reimbursement?

STEP 2: RECRUITMENT PLAN: COMPENSATION?STEP 2: RECRUITMENT PLAN: COMPENSATION?1. Must not be coercive and must be approved 

by IRB2. Compensation must be equal to all p q

participants3 Reimbursement for expenses3. Reimbursement for expenses4. Compensation for time commitment

C ti f i i5. Compensation for inconvenience or discomfort

STEP 3‐BUDGETSTEP 3 BUDGET

How much is it going to cost for you to recruit and screen?What is the sponsor contributing to recruitment?

E.g., Advertising firm? National campaign, materials? 

Recruitment costs:Costs for advertising, flyers, website design

Costs for staff time (community networking, developing l frecruitment materials, posting information, contacting 

colleagues, contact participants,)

Screening costs :Screening costs :Telephone screening

Screening failuresScreening failures

PLANNING‐BUDGET PERSONNEL TIMETime estimates Screen Dose Titration MAINTENANCE

Timeline in Study Visit 0 Visit 1 Visit 2 Visit 12 Visit 13/Final Total/participant

ItemPersonnel Needed 

* Pre‐visit Screen Visit Baseline Week2 Week42 Week48

Patient Qualification/ScreeningRecruitment SC 60Administrative Time (reg binder, filing, billing) SC 60

Phone screening SC 30Visit Prep/Scheduling SC 60 60 60 60 60Informed Consent SC 30Inclusion/exclusion SC 30Patient History MD 30Patient History MD 30Physical Exam MD 20Vital Signs MD 15 15 15 15Menarcheal status (female) MD 5 5 5 5 5Urine Pregnancy Test SC 15 15 15 15

Serum Pregnancy Test SC/Nurse/CRU 10

Clinical Laboratory Tests SC/Nurse/CRU 45 4512-lead ECG SC 20 20Reading of ECG MD 10 10assessment1 SC 25assessment2 SC 180assessment3 SC 90assessment4 SC 30 30 30assessment5 SC 15 15assessment6 SC 20 20

t7 SC 15assessment7 SC 15assessment8 SC 15 15 15assessment9 MD 15 15 15Adverse event collection MD 15 15 15 15 15Prior/con meds SC 10 10 10 10 10IP dispensed SC/MD 10 10 10IP instruc/compliance/accountability SC 15 15 15 15

Post Visit ProcessingR l t /El t i l i 20 20 20 20 15Regulatory/Electronic logging 20 20 20 20 15Scoring of measures SC 20 20 20 20 20Completion/collection/review of study forms SC 45 45 45 45 45Data entry SC 30 30 30 30 30Processing Lab samples SC 45 45PI review of CRFs PI 20 20 20 20 20Team administrative (meetings, trainings)/mo Team

Total Study Coordinator (SC)Time (hr) 2.50 13.83 5.92 4.33 3.83 7.92 83.08Total Physician (MD) Time 1 83 0 83 0 58 0 33 1 00 8 75Total Physician (MD) Time 1.83 0.83 0.58 0.33 1.00 8.75Total PI Time (hrs) 1.33 0.67 0.33 0.33 0.92 6.50Total Participant Time (hrs) 8.67 3.00 1.42 0.92 4.33 30.67

Particpant reimbursement $        130  $          45  $          25  $          15  $          65  $                 485 

PLANNING‐BUDGETSPONSOR BUDGET WORKSHEET - Costs Billable To RESEARCH Study

Principal Investigator: Sponsor:Study Title: Start Date:

A. ***STARTUP COSTS (non-refundable): Base 30% IDC TTL Inv.Investigator MeetingInvestigator Meeting - - -

IRB Fee: Awards >$50,000.00 = $2000Protocol submissionConsent development

Administrative Fee: (budget, contract, recruitment, regulatory set-up) $ 3,000.00 900.00 3,900.00 CRU start upOther: Long DistanceSUB-TOTAL STARTUP COSTS $ 3,000.00 $ 900.00 3,900.00

C. PER PATIENT COSTS:Standard of Care

(SOC) or Research Pre-screening Visit 0 Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 7 Visit 8 Visit 13/Final TotalResearch (R) Screen Visit Baseline Week2 Week4 Week6 Week9 Week18 Week24 Week48

Telephone screen Research (R) $ 30.00

Informed consent Research (R) $ 100.00

Physical exam/med hx Research (R) $ 150.00 $ 50.00 $ 50.00 $ 50.00 $ 50.00 $ 50.00 $ 50.00 $ 50.00 $ 50.00 Assessment 1 Research (R) $ 100.00 ( ) $Assessment 2 Research (R) $ 100.00 Clinical Laboratory Tests Research (R) $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 ECG readings Research (R) $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00 $ 100.00

Prizes, treats, supplies Research (R) $ 5.00 Patient Stipend Research (R) $ 50.00 Patient Parking Research (R) $ 20.00 SUB-TOTAL PER PATIENT COSTS $ 30.00 $725.00 $250.00 $250.00 $250.00 $250.00 $250.00 $250.00 $250.00 $250.00

N b PATIENTNumber PATIENT Telephone Screened 50.00N Phone screen

NUMBER OF PATIENTS Screened 20.00N SCREEN

NUMBER OF PATIENTS Enrolled 10.00N ENROLL

SUB-TOTAL PATIENT COSTS $ 36,000.00

D. ***OTHER INVOICE ITEMS: TO BE INCLUDED IN CONTRACT UPON OCCURRENCE Base 30% IDC TTL Invoice

Recruitment costs $ 9,200.00 $ 2,760.00 $ 11,960.00 Unscheduled Safety Visits *Total Amount to Be Unscheduled SRSFDA Audit Fee Received From Sponsor *

IRB Fee - Continuing Review (does not include "Other invoice items")Amendment Other invoice items will be invoiced as they occurQuerie Resolution *Note: Total amount to be received is based on an estimated recruitment numbers of subjects. SAE Final total is subject to change according to actual number of participants Total of Other Invoice Items

STEP 4: DEVELOP RECRUITMENT MATERIALSSTEP 4: DEVELOP RECRUITMENT MATERIALS

Flyers/Brochures/TearsheetsTemplates available from CTRC: http://www.uth.tmc.edu/ctrc/recruitment.html

Example flyer

Ads (radio, newspaper, tv): develop scriptsWebsite contentCollecting information electronically or throughCollecting information electronically or through the web:

Caution: confidentiality of participants must beCaution: confidentiality of participants must be protected

All PHI must be kept on secure servers in zone 100All PHI must be kept on secure servers in zone 100

STEP 4: DEVELOP SCREENING MATERIALSSTEP 4: DEVELOP SCREENING MATERIALSPre‐Screening participants

With CPHS approval of waiver of authorization, the study team may conduct preliminary screening through research registry or conducting telephone screens

Screening form, including:Inclusion/exclusion criteriaPotential participant contact information

Recruitment script that explains how the person’s bt i d i t d t d d iname was obtained, introduces study design, 

requirements, risks, benefits, study medication, location of the researchlocation of the researchCaution: No participants can undergo study procedures (e.g., discontinuation of prohibited p ( g , pmedications until they are consented)

CLINICAL TRIAL WEBSITESCLINICAL TRIAL WEBSITES

Clinical trials.govOnline database of federal and sponsored trials

Registration of certain clinical trials is mandatory

Research Match: tool that helps connect volunteers with researchers.tool that helps connect volunteers with researchers. The database will sent invitation notices to potentially eligible volunteers

UT Health Clinical Trials pageMaintained by CTRCy

ASSEMBLE SCREENING TOOLSASSEMBLE SCREENING TOOLSScreening logs: documentation of participants screened, including dates, reason for exclusion, and if possible gender and ageWaiting ListsParticipant database: for future researchParticipant database: for future research

STEP 5: IRB APPROVALAll advertisements and recruitment methods/materials must be reviewed and approved by CPHSAll advertisements and recruitment methods/materials must be reviewed and approved by CPHS 

prior to implementation to assure that the information does not promise or imply a certainty of benefit beyond what is contained in the protocol/informed consent.

Guidelines for Recruitment Flyers, Ads, Posters, & Brochureshttp://www uth tmc edu/orsc/guidelines/recruitment htmlhttp://www.uth.tmc.edu/orsc/guidelines/recruitment.html

Recruitment Information should include some of the following elements (those in bold are mandatory):

“Research” is specified.

The ages for eligibility.

I l i /E l i it i ( “Ri ht h d d P ti i t l ”)Inclusion/Exclusion criteria (e.g., “Right‐handed Participants only”).

The purpose of the research must be clearly stated.

The amount of time required to complete the study.

Any benefits (Note: a straightforward and truthful description of the benefits to the subject for participation in the study e g no charge for taking part in the study no‐cost health examination or providing treatment andstudy, e.g., no charge for taking part in the study, no‐cost health examination, or providing treatment and counseling for the drug addictions.)

Any risks.  (Note: If there are minimal risks other than mild boredom or mild fatigue, you may either include them or state that they will be discussed prior to the beginning of the study.)

The contact person’s name is identified.

The institution is identified.

Monetary compensation information is optional.(Note: Although the consent document must specify the EXACT amount of any financial compensation, recruitment materials should state that monetary compensation will be provided. 

The location of the researchThe location of the research.

Things that should be avoided:Do not emphasize monetary compensation.Do not state the amount of compensation.Do not use catchy words such as “exciting”, “cutting‐edge”, etc.Do not recruit children directlyDo not recruit children directly.Do not misstate information contained within the protocol

STEP 6: RECRUIT!STEP 6: RECRUIT!Develop and maintain community relationships

Network with other providers, schools, and groupsEstablish give and take relationships with the community

Post Flyers in various locationsIdentify locations where you will find potential participants (ensure you receive approval to post)

HospitalslClinics

FacilitiesSchoolsSupermarkets, libraries, employment centers,

MailoutsSend letters and flyers to colleagues, support groups, past patients

AdvertiseStart with UT MediaRadio tv newpaperRadio, tv, newpaperwebsites

PresentationsStart with your department, school, institutionSupport groups, organizations

Attend Community eventsFundraisersResource fairs

UT RESOURCESUT RESOURCESOffice of sponsored projectsCTRS

http://www.uth.tmc.edu/ctrc/recruitment.htmlCPHS

http://www.uth.tmc.edu/orsc/guidelines/recruitmp // / /g /ent.htmlMedia Relations http://www.uthouston.edu/advancement/public‐affairs/media‐relations.htmOffice of communications/graphic design (websites, flyers, logos)Office of Advancement/Communications/design

STEP 7: SCREEN!STEP 7: SCREEN!Have staff available to take callsTrain your staffTrain your staff

GCP training? Knowledge of protocol, inclusion/exclusionKnowledge about condition and study populationConfidentiality issuesCommunication style (a lot of information presented y ( punderstandably and in a non‐coercive manner)Ability to establish rapport with potential participantsAbility to listen, be polite, yet keep calls as a screen and redirect y p y pparticipants to the screening interviewCultural considerationsSafetyyAbility to be sensitive in explaining if did not meet screening criteriaAbility to refer to services if needed

Continuously update the waiting list

STEP 8: ASSESS YOUR RECRUITMENT

STRATEGIESSTRATEGIES

Obtain the source of the referral when screeningEvaluate recruitment milestonesRevise recruitment plan as needed (withRevise recruitment plan as needed (with approval from CPHS)Obtain feedback from participants on reasonsObtain feedback from participants on reasons they did/did not participate and the screening experience in generalexperience in generalPeriodically re‐distribute flyers and re‐send l tt t llletters to colleagues

RECRUITMENT CHALLENGESRECRUITMENT CHALLENGES

Study visit burdeninform participant of number of visits, length of visits and study length

Inform participants of study requirements from the onset (e.g., prohibited concomitant medications, no new therapies)Assist participants with appts/planning visitsp p pp /p g

Confirm and remind for upcoming visit (emails, cards, calendars)

Provide doctor excuses for missed work/school

Transportation (maps, costs to travel)p ( p , )

RECRUITMENT CHALLENGESRECRUITMENT CHALLENGESConsenting challenges

A h i f ti i ti i li i l t i l d t kiApprehension of participating in clinical trial and taking new medicationFear of non‐FDA approved drugFear of adverse affectsReluctance to risk receiving placeboFear of study procedures (e g blood draws or otherFear of study procedures (e.g., blood draws or other procedures)

Having a well‐trained and understanding clinical staff and PI to help address these concernsstaff and PI to help address these concernsProviding participants with the safety nets they need to feel comfortable (contact numbers, pagers, ( , p g ,emergency information)Current trends in community/condition

RETENTION STRATEGIESRETENTION STRATEGIESVisit Experience

keep visits as smooth and brief as possible by preparing ahead for participants, not over‐scheduling, and ensuring wait times are minimizedHave waiting room materials (magazines, toys)Reduce annoyances/barriers to participant (e.g., parking convenient, wait time)

Avoid and Address False ExpectationsAvoid and Address False ExpectationsBe continuously honest about study limitationsBe sympathetic to concerns about lack of response/remind patients contributing to sciencePI should be available to address patient concerns/questionsPI should be available to address patient concerns/questions

Build and maintain relationships with participantsStudy personnel should be professional and pleasantUse clinical skills and empathy to help participants with difficult proceduresConduct specialized training with study staff if specialized population (e.g., children, aggression, etc)Establish trust with your participants

Communication/Follow‐upCommunication/Follow upCall participants between visits to check in (especially if long interval between visits)Confirm and remind of upcoming appointmentsObtain updad contact information for participants

RETENTION STRATEGIESRETENTION STRATEGIESKeeping eligible participants, eligible:

Re‐affirm/remind of exclusion/prohibited concomitant medications at each visit

A ti i t bl /i f h ifi ti i tAnticipate problems/issues for each specific participant (e.g., cannot swallow compound, side effects, coordination of care))

Counsel on strategies to improve IP compliance

Remind of importance of visit windows

Explain the preferred process for dropping out of the study (e.g., importance of being evaluated and returning study medication)If participant needs to be terminated from study provide follow‐up referrals (leave on a good note)