What You Should Know:
– Advarra, a prominent player in regulatory review solutions and clinical research technology has released findings from its 2023 Study Activation Survey. Since 2018, nearly 60% of clinical research sites have experienced an increase in study volume. The survey reveals sites are also managing more sponsor-provided technology, which is now perceived as a higher burden than contracting and budgeting.
– The 2023 Study Activation Survey aimed to capture the perspectives and experiences of over 500 North American clinical research professionals. The survey rated the impact of processes such as site feasibility, budgeting and contracting, patient recruitment, and subject compensation on study startup, as well as the role of technology and site tools and their benefits and burdens.
Key findings from the survey include:
– Technology Utilization: More than half of site respondents utilize various technologies such as electronic data capture (EDC), interactive voice response (IVR), and safety letter distribution systems. Between 33-50% of sites are using electronic patient reported outcomes (ePRO), electronic clinical outcomes assessment (eCOA), learning management, document exchange, and site payment systems in over three-quarters of studies.
– Technology Impact: Despite advances in clinical trial systems, sites express concerns about technology’s impact on their daily workflows. Sponsor technology setup and training during study startup are considered the most burdensome activities. Over half of sites (55%) find setup and training on sponsor technology extremely or very burdensome, with 67% feeling that it’s worse than five years ago.
– Multiple Logins: As technology usage increases, site staff face a commensurate increase in the number of logins required, with nearly 70% of respondents reporting having six or more logins per study.
– Credential Consolidation: To address the complexity of multiple logins, 81% of respondents believe that using their own site credentials to access various systems would be valuable.
– Burden in Clinical Trials: Budgeting (41%) and contracting (36%) are rated as the next extremely or very burdensome activities for clinical trials after sponsor technology setup and training.
– Contract and Budget Utilization: Only 36% of sites report that sponsors and contract research organizations (CROs) always or often leverage existing contract terms, and budgets are similarly underutilized, with only 31% stating that sponsors and CROs always or often use existing terms.
– Value of eReg Binder Technology: 80% of sites find it extremely or very valuable to have their organization’s eReg binder technology connected to the sponsor and CRO technology used for document exchange and review in study startup.
– Site Engagement Tools: At least 50% of sites find site engagement tools to be very or extremely useful, with the top four tools, including visit essentials, quick links to other study tools, visit calculator, and protocol text search, rated as very or extremely useful by more than 80% of sites.
Feasibility Surveys: Nearly half of sites (49%) say the burden of feasibility surveys has increased over the past five years, possibly due to redundant site capability questions.
eConsent: Only 14% of sites report that sponsors or CROs consistently offer eConsent for more than 75% of site studies.
Reimbursement Requests: Sites frequently request reimbursement for costs associated with remote monitoring, including CRO monitoring visits (71%) and remote monitoring setup (63%).
“Sites are increasingly saddled with complex technologies and duplicative, administrative tasks. We need to come together as an industry and support both sites and sponsors with technology that works for each stakeholder respectively and helps improve clinical research – not hinder it,” said Gadi Saarony, CEO of Advarra. “Advarra uniquely knows and understands the needs of sponsors, CROs, sites, and participants and is committed to driving industrywide stakeholder collaboration and to be the pioneer in connecting the clinical research ecosystem.”