New clinical trial industry survey reveals increased burdens on sites

Dais World | 17/10/2023 10:07 PM

Nearly 60% of site respondents say study volume is higher and more than half (55%) cite technology as the biggest challenge among all study startup activities

Two-thirds (67%) indicate setup and training on trial sponsor technology are more burdensome now versus five years ago

Advarra, the market leader in regulatory review solutions and clinical research technology for sites and sponsors, today revealed findings from its 2023 Study Activation Survey indicating increases in site burden since 2018. Nearly 60% of sites say their study volume is higher plus they are managing more sponsor-provided technology, which was rated a higher burden than contracting and budgeting. More than half of site respondents use electronic data capture (EDC), interactive voice response (IVR), and safety letter distribution systems. Between 33-50% of sites are also using electronic patient-reported outcomes (ePRO) or electronic clinical outcomes assessment (eCOA), learning management, document exchange, and site payment systems in more than three-quarters of studies.

Despite advances in clinical trial systems, sites are raising concerns over the realities of technology's impact on their day-to-day workflows. Site respondents overwhelmingly find sponsor technology setup and training the most burdensome activity of study startup. Over half of sites (55%) report setup and training on sponsor technology to be extremely or very burdensome, and 67% say it's worse than just five years ago. With increased use of technologies comes a commensurate increase in logins for site staff – in fact, nearly 70% of respondents report having six or more logins per study. To address this complexity, 81% say using their own site credentials would be valuable to access all the various systems.

"Technology that has been layered into sites' workflows has often increased challenges in lieu of minimizing the daily burden of clinical trial execution," said Kari L Delahunty, Chief Operating Officer at Alliance for Multispecialty Research, a site network with 28 locations. "Leveraging the relationship between sites and industry, we have an opportunity to connect and optimize technology and process allowing us to streamline the clinical trial process, provide better delivery consistency, and increase quality. Collaborating to reduce variability and increase predictability in the conduct of clinical trials supports our goal of improving health for patients worldwide."

Additional key findings include the following:

• Budgeting (41%) and contracting (36%) were rated the next extremely or very burdensome activity for clinical trials after sponsor technology setup and training.
• Only 36% report sponsors and contract research organizations (CROs) always or often leverage existing contract terms. Budgets are similar, to slightly lower with only 31% reporting sponsors and CROs always or often use existing terms.
• 80% of sites rate having their own organization's eReg binder technology connected to the sponsor and CRO technology used for document exchange and review in study startup as extremely or very valuable.
• At least 50% of sites rated the site engagement tool options presented in the survey as very or extremely useful. The top four tools were rated very or extremely useful by more than 80% of sites: visit essentials (activities at each visit), quick links to other study tools, visit calculator to calculate patient visit windows, and protocol text search. 
• Nearly half of sites (49%) say the burden of feasibility surveys has increased over the past five years, likely due to redundant site capability questions as less than a fourth of respondents say most feasibility surveys contain questions specific to the study.
• Only 14% of sites report sponsors or CROs consistently offer eConsent for more than 75% of site studies.
• Sites most often 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."

About the Advarra 2023 Study Activation Survey

The 2023 Study Activation Survey aimed to capture the perspectives and experiences from 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. The survey targeted experienced clinical research personnel from academic medical centres (38%), non-academic medical centres and hospitals (17%), private practices with both patient care and clinical research (16%), and professional research sites (13%). Of the respondents, 90% participated in industry-funded multicenter studies, 57% participated in government and other grant-funded research, and 60% participated in investigator-initiated trials. Most participated in a combination of trial types. The majority (67%) of respondents participated in greater than 26 studies per year.

About Advarra

Advarra makes clinical research safer, smarter, and faster.  Advarra services and technology solutions safeguard trial participants, ensure quality and protocol compliance, optimize research process performance, and enable collaboration among clinical research sponsors, CROs, research sites, investigators, and patients. With trusted and unequalled independent review committee services, innovative software solutions, and experienced consultants, Advarra has the expertise and technology needed to advance clinical research so our clients can advance human health.

Press release by CISION

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