Electronic trial applications and the next phase of site interactions
The Pulse on Technology by Elisa Cascade
The relationship between sponsors, CROs and clinical trial sites is a crucial aspect of clinical trial success. Historically, most trial communication has happened in person or via fax, but over the past 10 to 15 years, communication has largely shifted to email. Today, with the increasing popularity of electronic trial applications, sponsor, CRO and clinical trial site interactions are now beginning the next phase of process transformation with access to study resources, facilitated workflow and transparency for all parties.
So what is an electronic trial application (ETA)? We define ETAs quite broadly as tools to optimize workflow processes, site engagement and training from startup through closeout. Sometimes these can be referred to as platforms or portals.
According to the DrugDev Investigator Survey, at least 80% of global sites have used ETAs on at least one study. However, adoption across all studies is much lower (~20%), suggesting that while sponsors and CROs are trialing ETAs, they are not yet standard practice. The highest rated barrier to adoption of ETAs is still that sites have not been asked to use one, or that sponsors have not suggested it. This was a barrier “all the time” or “often” for 33% of sites.
Sites that are engaged in a clinical trial through an ETA have noted performance improvements in key metrics such as patient enrollment, patient retention, protocol compliance, data query resolution and overall study conduct efficiency (activation timelines, collaboration, transparency, etc.). In fact, the DrugDev Investigatory survey found that 54% of sites were extremely or very positive that these ETAs will improve the efficiency of study conduct, 17% were somewhat positive and only 7% were a little positive or not at all positive (22% responded don’t know, likely due to unfamiliarity with ETAs).
A broad variety of modules are available to support the end-to-end clinical operations processes including, but not limited to:
- eFeasibility: Administer online surveys and assess response data in real time to support site selection.
- Site Activation: Contract negotiations, budget development and regulatory document collection. More advanced applications contain workflow and real-time reporting capabilities.
- Learning Management System: Multimedia education, due dates/automatic reminders, compliance reporting/tracking, interactive comprehension assessments and completion certificates.
- eConsent: Explanatory video, audio narration, pictures and glossary terms to explain study documents to patients and capture patient consent in a transparent and auditable manner.
- Site Engagement: Provides sites with news, resources (e.g., visit guide, non-clinical supply ordering), tools (e.g., patient eligibility screener, dosing calculators) and motivation (e.g., enrollment competitions, achievement badges) to keep them active and inspired during the study.
- Investigator Payments: Payment activity tracking and transparency, connectivity to sponsor systems (e.g., EDC, CTMS, etc.), automation of activities (e.g., invoice preparation, pass-through costs) and self-service functionality (e.g., invoice submission, payment approvals/administration).
- Study Trackers: Process automation and dashboard reporting for critical trial processes (e.g., enrollment diversity, patient retention, closeout visits).
Currently, the marketplace for these electronic trial applications is in the “growth phase” and is comprised of multiple suppliers whose offerings range from one module to a more comprehensive suite of solutions. The result is precious little standardization across the industry, and a somewhat haphazard approach to engaging sites.
To combat this, technology providers are moving towards unified sign-on, allowing sites to access ETA modules across various providers. While unified sign-on addresses the issue of site access, realizing a consistent user experience is likely to require an integrated, end-to-end suite of solutions that provide sites with everything they need to run a trial efficiently.
As a result, there seems to be a growing tension between ‘best in class’ modules offered by different technology companies and providing a unified user experience through a single platform. Sponsors and CROs want to make clinical trial conduct more efficient for sites, and indeed for themselves, and sites want a streamlined, less administratively burdensome clinical trial experience. However, with best in class modules potentially being provided by different vendors in disparate systems, this can detract from providing sites with the seamless and straightforward user experience they crave.
Even with a move toward a unified, end-to-end user experience across the clinical operations process, we do not believe that anything will ever replace the personal relationship between sites, sponsors and CROs, especially when it comes to scientific discussions around a protocol. However, much can be done to improve interactions and to build stronger relationships through improved communication links and processes. Consistent use of straightforward, intuitive technology that makes a site’s life easier and removes burden is the best way to ensure effective, timely and positive interactions with a site.