Recruitment Metrics from TogetherRA: A Study in Rheumatoid Arthritis Patients to Evaluate Feasibility of a Direct-to-Patient Research Approach
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- A study utilized a direct-to-patient recruitment model to collect patient-reported outcomes, medical records, and genomic data from rheumatoid arthritis patients. This approach resulted in rapid enrollment, with the first patient in to last patient in period taking only 18 weeks. - A total of 1,000 patients enrolled and provided various levels of data, with 48% providing all data types. Compliance with individual study components ranged from 59-82%. - Future analyses will examine the completeness and quality of the medical record and genomic data collected, and explore genomic predictors of biological response. The direct-to-patient approach showed potential for efficiently obtaining multiple data types from patients.
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Recruitment Metrics from TogetherRA: A Study in Rheumatoid Arthritis Patients to Evaluate Feasibility of a Direct-to-Patient Research Approach
- 1. Conclusion Recruitment metrics from this study suggest that utilizing a direct-to-patient design can result in rapid recruitment even into studies that combine patient-reported outcomes with medical record and genomic data. Direct-to-patient recruitment design resulted in a shortened enrollment period, the total time between First patient in (FPI) to Last patient in (LPI) was 18 weeks. Patient-reported outcomes, medical record, and genomic data was available for approximately 50% of patients; compliance with individual study components ranged from 59% to 82% Future analyses will examine completeness and quality of data collected from medical records and genomic predictors of biologic response. Recruitment Metrics From Together RA: A Study in Rheumatoid Arthritis Patients to Evaluate Feasibility of a Direct-to-Patient Research Approach Elisa Cascade, MBA1, John Reites1, Tia Carmon1, Dawn Blessing2, Joyce Tung2, David Hinds, Ph.D.2 , Chao Tian, Ph.D.2, Diego Miralles, MD ³, Dimitri Talantov MD ³ 1 Quintiles, RTP, NC, USA 2 23andMe, Mountain View, CA,USA ³Janssen Healthcare Innovation, Janssen Pharmaceuticals, Johnson & Johnson, La Jolla, CA,USA Author(s) of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: This study was funded by Janssen Healthcare Innovation, Janssen Pharmaceutical Companies. Elisa Cascade-Nothing to disclose, John Reites-Nothing to disclose, Tia Carmon-Nothing to disclose, Dawn Blessing-Nothing to disclose, Joyce Tung- Nothing to disclose, David Hinds, Ph.D.-Nothing to disclose, Chao Tian, Ph.D.-Nothing to disclose, Diego Miralles, Janssen Healthcare Innovation, Janssen Pharmaceutical Companies, Dmitri Talantov- Janssen Healthcare Innovation, Janssen Pharmaceutical Companies 49th DIA Annual Meeting, June 23-27, 2013, Boston, Massachusetts Background & Objective • Increased demand for real-world data across multiple stakeholders is driving researchers to explore new methods for research that can enable cost and time efficiencies. • The objective of this study is to examine whether a direct-to-patient research approach can be used to complement conventional clinical research methods. • Direct-to-patient research involves the direct recruitment of patients and conduct of studies without the use of physician sites. • We believe that this is the first study to use a direct-to-patient approach to collect and link patient-reported outcomes, medical record, and genomic data. Methods • Patients from Quintiles’ communities, digital partners, and social media outreach were invited to access study details, consent to participate, and screen against the study’s inclusion/exclusion criteria for eligibility. • The first 1,000 eligible, consenting patients were enrolled. • Enrolled patients completed 2 web-based surveys, an authorization for medical record release, and submitted a saliva sample. oPatients were instructed provide to a saliva sample and return the kit in postage paid packaging. oPost medical record release we obtained a copy of the patients’ medical record from their physician and chart data abstraction was performed. Characteristic (n=1,000) Number (%) Age: 21-45 46-55 56-75 237 (24%) 371 (37%) 392 (39%) Years Since Diagnosis <5 Years Ago 5-15 Years ago > 15 Years ago 325 (33%) 433 (43%) 242 (24%) Anti-TNF α Exposure: 1 Anti-TNF α 2 Anti-TNF α ≥3 Anti-TNF α3 None 416 (42%) 316 (32%) 262 (26%) 6 (<1%) 48% 59% 80% 82% 0% 20% 40% 60% 80% 100% PRO + MR + Lab MR Lab + PRO Lab Figure 3. Data Submission Rates (n=1,000) % Data Collected Figure 2. Condition History Characteristics Results • Over the 18 week enrollment period, 22,855 patients visited the study website (see Figure 1): o8,142 (36%) attempted to screen for the study. o4,289 (19%) completed the screener with a self-reported RA diagnosis. o1,421 (6%) met the study enrollment criteria based on: self-reported RA diagnosis; previous exposure to an anti-TNFα; age 21-75; Caucasian; and located in any US state except New York or Maryland. • 1,000 proceeded to complete enrollment by consenting to provide medical record release and a DNA saliva sample for genetic analysis. • Figure 2 displays characteristics of the 1,000 patients who successfully enrolled for the study. o 24% of study enrollees were age 21 to 45, 37% were 46 to 55, and 39% were 56 to 75. oTwo-thirds of participants (67%) were diagnosed 5 or more years ago. o42% of RA patients reported exposure to only 1 anti-TNFα, 32% said they had taken two different treatments, and 26% had been treated with three or more agents. • 48% (481) of participants completed all study activities (see Figure 3): o 82% (818) provided lab data. o 80% (798) subjects completed the genotyping. o 59% (591) of subject’s medical records were retrieved. 74 155 230 322 396 449 488 531 565 633 697 752 795 829 897 928 944 987 1000 0 200 400 600 800 1000 1200 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Figure 1. Recruitment Over 18 Week Enrollment Period Enrollment actuals FPI to LPI in 18 weeks