Recruiting and Retention (R&R) for Human Subjects Research: Part 1 Inventory and Open Discussion

Transcription

1 Recruiting and Retention (R&R) for Human Subjects Research: Part 1 Inventory and Open Discussion Ariana Winder, CCRP Penn State CTSI Bench to Bedside and Beyond (B3) Seminar Series October 19, 2017

2 Objectives Industry current conditions New recruitment & retention specialist role PennState R&R methods inventory NCAT accrual & evidence-based metrics Challenges/barriers inventory

3 Source: Medrio eclinical Solutions

4 Why Aren t Studies Accruing? Protocol too complex Lack of preparation Recruitment materials patient motivations Lack of recruitment innovation Lack of R&R tracking Source: Kristina Lopienski, Forte Research

5 Why Aren t Studies Accruing? Elizabeth Mahon et al. Applied Clinical Trials (2015)

6 The image part with relationship ID rid1 was not found in the file. Recruitment Funnel Feasibility Analysis $129 - $336 / pt Pre-screening ICF Screening $90,000 annually 68% Participation Study End Penberthy LT, Dahman BA, Petkov VI, Deshazo JP. Effort required in eligibility screening for clinical trials.j Oncol Pract. 2012;8(6): Re-contact

7 Source: Forte Research

8 PennState s CTSI Promotes and supports clinical and translational science: Connecting PSU to emerging NIH initiatives Building connections across PSU for interdisciplinary, translational biomedical/ behavioral health research Providing consultation, education, funding and infrastructure resources for research Funded by NIH beginning in 2010

9 R&R Specialist Penn State Study Staff Consult on recruitment strategies, budgeting, regulatory and best practices Create and disseminate practical recruitment tools for study staff Hold workshops and other recruitment related events CTSI and PSCI Benchmark & monitor institutional research portfolio progress NCATS accrual metrics Assist with related institutional efforts Liaise with Recruitment Innovation Center (RIC) & other industry recruitment stakeholders Serve as Trial Innovation Network Team hub liaison & ResearchMatch institutional liaison Scientific Community

10 CTSA Common Metrics Initiative: Accrual Metrics % of Participants Accrued = # of participants accrued X 100 # of participants targeted % of Recruitment Period to Date = # of days elapsed since open to recruitment X 100 # of days trial will be open to recruitment Accrual Ratio = % of Participant Accrued % of Recruitment Period to Date

11 CTSA Common Metrics Initiative: Accrual Metrics # of participants targeted = 100 # days trial will be open to recruitment = 364 At the halfway point of the recruitment period, the trial has accrued 25 participants Accrual Ratio = 25 pppppppppppppppppppppppp 100 pppppppppppppppppppppppp 180 dddddddd 365 dddddddd Accrual Ratio = 0.51

12 CTSA Common Metrics Initiative: Accrual Metrics Accrual Metrics # accrued # targeted # days open # total days PennState Recruitment Efforts Recruitment Specialist Position R&R Working Group Literature Review 1:1 Investigator Consultations Results Dissemination Stakeholder Liaising Recruitment Database(s)

13 PSU Recruitment & Retention Working Group Mission To enable and facilitate information exchange for the advancement of PSU core values (respect, integrity, teamwork, excellence) for ourselves, our institution, and our community. These topics may relate to: R&R regulatory, methods, or other innovative techniques for study enrollment R&R related events hosted internally or externally R&R best practices, updates, scientific knowledge and evidence-based strategies R&R diversity, engagement, and special considerations for minority populations R&R efforts or initiatives in industry, other Recruitment Innovation Centers (RIC)s to watch Charter The working group will be comprised of Penn State investigators, leadership, staff and other R&R stakeholders (internally or externally) to accomplish our mission through open discussion and interaction at regularly scheduled monthly meetings. The working group will also provide a key resource for interacting with other recruitment groups such as the Trial Innovation Network (TIN) or external Recruitment Innovation Centers.

14 CTSA Trials Innovation Network provided website that allows users to search PSU studies for opportunities to participate. 8,727 users in :1 female: male

15 2,765

16 Recruitment Literature Review Background: CTSI / PSCI Goal: evidence-based recruitment in a central PA rural population Methods: rapid scoping review n=830 Database searches Covidence data management Manuscript preparation Results dissemination Source: Society for Clinical Research Sites (SCRS)

17 A PennState Front-Door Consent & Healthy Volunteers Database Recruitment Site CLINICAL TRIALS: Inpatient/ Outpatient or both? IPM: Patients or Patients & Families? Informed Consent Process Where? When? By Whom? How? econsent? Consent Tracking Cerner tracking capabilities? Yes/No/ Never/ Ask Later? Ariana Winder, CCRP Research Recruitment, Retention & Optimization Manager

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19 REDCap & REDCap Cloud Advanced data management and analytics solutions 116 countries 469,000+ projects 616,000+ users

20 PSU Survey Research Center

21 Enrollment Modeling Enrollment = 22.3% of clinical development timeline Source: Beth D. Harper. Monitor (2004)

22 Remote Trials Place-shifting Time-shifting* Hybrid*** Compliance Monitoring E-patient recruitment Patient training Consent telemedicine, clinical trials, enterprise healthcare software, and digital media

23 Manual Reviews High screen failure rate Time and labor intensive Costs typically not reimbursed Prone to human error 80% in free form text

24 R&R Informatics i2b2 is an NIH-funded National Center for Biomedical Computing focused on developing a scalable informatics network that enables use of existing clinical data for research ranging from discovery to targeted therapy/intervention studies that require identifiable cohorts. PSU provides training and data access for researchers such as for: Database query With permissions, to obtain contact information for participant recruitment

25 R&R Informatics

26 E-Recruitment Search Engine Marketing (PPC) Search Engine Marketing (SEO) Contextual Display Social Video Health Networks Patient Portals Source: CISCRP

27 Source: CISCRP

28 Crowdsourcing HITs Human Intelligence Tasks >500,000 registered users Online Consent Template

29 Cost of E-Recruitment

30 R&R Tracking Source: MD Connect

31 R&R Tracking Source: MD Connect

32 R&R Tracking Source: MD Connect

33 Recruitment & Advertising Policies Office for Research Protections Contact: The 330 Building, Suite 205, University Park, PA Phone: Fax:

34 Open Discussion

35 Reach out any time! Ariana M. Winder, CCRP Research Recruitment, Retention & Optimization Manager Cancer Institute Clinical & Translational Science Institute Pennsylvania State University College of Medicine MC: H147, Cancer Institute, 500 University Drive, Hershey, PA CTSI Suite 15B, 114 Henderson Building, University Park, PA Hershey: x University Park: (814) Google Cell: (814)