Recruitment Efforts Rhonda G K ost MD Clinical Research Officer Director Clinical Research S upport Office Study Accrual Many clinical trials fail to accrue Multiple calls for accountability in accrual ID: 593602
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Slide1
Measuring the Impact of
Recruitment Efforts
Rhonda G
. K
ost MDClinical Research OfficerDirector, Clinical Research Support OfficeSlide2
Study AccrualMany clinical trials fail to accrue Multiple calls for accountability in accrualEvaluation KFC 2012; IOM 2013; NCATS PAR 2015
No consensus metrics for “accrual success”Recruitment Taskforce paper, Acad Med, 2014
Kost 2016©2Slide3
Accrual MeasuresStudy AccrualTime to first enrollmentTime to complete accrualTimeliness
of accrual – Accrual IndexKost 2016©
3Slide4
Multiple Factors Affect Accrual
Kost 2016©
4Slide5
Infrastructure and Data CaptureProtocol Navigation (Brassil et al CTS 2014) --upstream Comprehensive
Recruitment ConsultData Rich Recruitment Core, (Kost et al CTS 2015)Common platform for protocol writing, IRB, study management, subject management (iRIS®)
Recruitment Management software (Clinical Conductor®)
Kost 2016©5Slide6
82
(9%)
decline
13
(<1%)
141
(45%)
Screen fail
46
(27%) drop
124
Completed
185
(36%)
No show
201 (19%)
Unable to Reach
255
(33%)
Fail prescreen
785
Pre-screened
530
Passed
Pre-screen
512
Referred/
Scheduled
311
Entered Screening
170
Passed Screening
124
Ongoing
Enrollment
867
1068
Kost 2016
©
Learning from Data
6Slide7
82
(9%)
decline
13
(<1%)
141
(45%)
Screen fail
46
(27%) drop
124
Completed
185
(36%)
No show
201 (19%)
Unable to Reach
255
(33%)
Fail prescreen
785
Pre-screened
530
Passed
Pre-screen
512
Referred/
Scheduled
311
Entered Screening
170
Passed Screening
124
Ongoing
Enrollment
867
1068
Cohort Identification
A
dvertising, social media,
capacity
Barriers,
Incentives
Barriers,
Incentives,
capacity
Participant experience
Participant experience
Kost 2016
©
Learning from Data
7Slide8
Defining the MeasuresAccrual Target
# evaluable participants needed (sample size from power calculation) captured in protocol and recruitment plan in electronic IRB/study management system
8Kost 2016
©Slide9
Defining the Measures
# Evaluables accrued-to-date (on-study + completed) Accrual Target (Evaluables)
9Percent Accrual, at a specific time point
Kost 2016©=Slide10
Percent Accrual Lacks
Context
Corregano et. al. Clin Transl Sci. 2015
10Slide11
Defining Time as Context
Predicted Time to Accrual Completion (PTAC)Refined and justified with the research team:2007-2010: consider burdens/incentives2011-2012: add investigators’ stated availability2013-2014: add LOA, vacations, delays for assay refinement, known August & December slow-downs, FDA review periods, competing protocols, grant deadlines, predictable delays
11Kost 2016©Slide12
Justifying the PTAC, exampleNeed
120 evaluable participants, criteria:HIV viral load, ART, CD4, nadirPrior study, similar population, screen/enroll = 3:1Estimate need to screen, 120 x 3 = 360 volunteers
Team can screen 10/week. Initial projection: 360/10 = 36 weeksReality check:
Entire team attends national meeting: + 1 weekHead coordinator plans 2-wk vacation + 2 weeksAugust slow-down in NYC recruitment + 2 weeksUnit closes x 2 weeks over Xmas + 2 weeks3 wk FDA hold for each of 3 dose increases + 9 weeksREVISED: +16 weeks Projected Time to Accrual Completion: 52 weeks12Kost 2016©Slide13
A new measure: Accrual
Index (AI)Progress toward goal
Fraction of enrollment period elapsed13Corregano et. al.
Clin Transl Sci. 2015= 1/4 accrued 1/2 time elapsed=0.5; < 1.0 = behind 2/3 accrued 2/3 time elapsed=1.0; on-time accrual
How to interpret:Slide14
Accrual Index (AI)
14
Corregano et. al. Clin Transl Sci. 2015
=Example: HIV study with 52 wk (12 month) PTAC, on day 150 , accrual includes 20 completed + 70 on-study: (90 evaluable) / (120 accrual target) (150 days/30) / 12 month PTAC=.75.70=1.1AI
=Slide15
Data to track AI Once:Sample size (evaluables in power calculation)
Intended # to screen (data-driven estimate)Projected Time to Accrual Completion (PTAC)Date of recruitment startFor Updates:
# participants (enrolled on-study + completed)Date of update15Kost 2016
©Slide16
Three ways to use the AIA retrospective assessment of protocol accrual Case Studies – patterns?
Real-time use in a DashboardAudience: investigators, recruiters, managers, leadership, sponsorsKost 2016
©16Slide17
Characteristics of protocols
2007-2014
Corregano et. al. Clin Transl Sci.
201517Slide18
Accrual Index
Corregano et. al.
Clin Transl Sci.
201518Slide19
Corregano et. al.
Clin
Transl Sci. 2015
19Slide20
Corregano et. al.
Clin
Transl Sci. 2015
20Slide21
Corregano et. al.
Clin
Transl Sci. 201521Slide22
Accrual Index Dashboard: Fields
22
Kost 2016©Slide23
AI Dashboard23
Corregano et. al.
Clin Transl
Sci. 201523Slide24
Accrual Index Dashboard Report
24
PTL1
PTL2PTL3PTL4PTL5PTL6PTL7PTL8PTL9PTL10PTL11PTL12PTL13PTL14PTL15PTL16PTL19
PTL20PTL21PTL22PTL23PTL24PTL25PTL26PTL27PTL28PTL29PTL30PTL31PTL32PT343PTL35PRL36PTL37PTL38PTL39PTL40PTL41PTL42PLT43PTL44PTL45
Kost 2016
©
24Slide25
Measuring Other Recruitment EffortsRegistries/repositories – enrollment yield
Advertising - effectivenessCall management - impactParticipant Experience protections, satisfaction, operations, retention, re-enrollment, word of mouth
25Kost 2016©Slide26
Research Volunteer Repository26
P
ositive informed consent23% of Repository members have enrolled in/completed >
1 study; 85% retention in the studiesOf those reached via queries, 50% enrolled; 92% retained in the studiesKost 2016©Slide27
Research Volunteer Repository27
20% Hispanic
23% Hispanic
Kost 2016©Age, race, ethnicity Slide28
Recruitment Core Call Management 28
CRROSS recruitment core prescreen/scheduling provided: Jan – mid-March;
Services discontinued by research team: mid-March
Late May, PI called to complain about lag in recruitmentCRROSS recruitment services resumed: JuneSlide29
Advertising29
Advertising campaigns to recruit HIV infected individuals, on/off ART, for Phase I/II trialsSlide30
30Slide31
31
Kost 2016©Geographic distribution of HIV-positive participants
enrolled; by zip code; BatchgeoSlide32
Participant experienceResearch Participant Perception SurveyValidated at 15 NIH supported sites, robust, reliable,Overall rating, “Would recommend”, motivation to join, stay, leave study, consent, trust, etc.
Opportunity to identify better performers, better practicesShorter RPPS –Validated, reliableFlash: compensation impacts response, reliability , ratingsBackbone survey; menu
of add-in questionsWill be available with analysis handbook32
Kost 2011, Yessis 2012, Kost 2013, Kost 2014Slide33
Measuring the Impact of Patient and Stakeholder EngagementFrom our Community Engaged Reseach Navigation Program (CEnR-Nav
) process – TrackStakeholder characteristics, participationStakeholder generated themes/suggestionsIncorporation of stakeholder recommendationsAnalysis of recruitment outcomes +/- stakeholder input
33Kost et al, Acad Med,
ePub April 16 2016Slide34
AcknowledgmentsKatelyn Bastert, MA, Recruitment Assistant
Kadija Fofana, MPH Recruitment SpecialistLauren Corregano, MSW, past Recruitment Specialist
Tyler Lauren Rainer, past Recruitment AssistantCaroline Melendez, past Recruitment Specialist
Donna Brassil, BSN, Research Protocol NavigatorRoss Gilmartin, BioinformaticsUmmey Fatima Johra, BioinformaticsEmil C. Gotschlich, MD, Chair, Institutional Review BoardBarry S. Coller, MD CCTS-PI34Slide35
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