Florence Healthcare Archives

Catherine Gregor is the chief clinical trial officer at Florence Healthcare. The company’s clinical trial software is used in more than 12,000 research sites in 45 countries for management of documents, data, and workflows. We asked Gregor about the clinical trial technology landscape in 2023. Why is remote clinical research connectivity so important? Remote connectivity became increasingly important in 2020, 2021 and 2022 as the clinical research industry reacted to changes in site access and the move to work from home. Work that was traditionally done on-site and in-person prior to the pandemic had to be reimagined in order to keep patients on study and keep data moving. This change forced sponsors and sites to collaborate electronically to maintain data quality and study oversight. Accordingly, remote monitoring has ranked as the top problem sponsors and sites are working to solve for the last two years (with 28% ranking it as #1 in 2021 and 29% ranking it as #1 in 2022). This trend is expected to continue into 2023 despite the relaxation of pandemic measures as sites and sponsors have realized the longer-term value of remote access. Some of the motivating factors we are seeing are: Scanning and uploading paper documents is cumbersome and inefficient and takes away time that sites could be spending on patient care. Government regulators and sponsors have realized the clinical research industry needs better infrastructure in place in case of another global emergency. COVID taught us that rapid enrollment requires new types of sites, like pharmacy networks, primary care practices, and community clinics. Having 24/7 remote links to these sites increases oversight and monitoring capabilities across geographically dispersed and research-naive sites. Sponsors and CROs have seen an average savings of over $1 million for a study with 50 sites when using remote monitoring. How will technology advance clinical trials and research? In 2023, the focus will be on site enablement technology–technology that better accommodates site workflows by helping them create, edit, sign and share their documents and data with sponsors in real time and with less effort. Sponsors and CROs recognize the vital role sites play in creating access to patients, especially in underrepresented and rare communities. If we are to be successful in better connecting with patients, then the industry desperately needs technology that will eliminate mundane and repetitive busywork for sites–like entering data into multiple portals or copying documents–and instead empower them to focus on enrolling and caring for patients. Further, sponsors and sites are both seeking ways to harness technology to increase patient reach and meet the growing demands of diversity initiatives and personalized medicine. As a result, we are seeing an uptick in demand for technology solutions that prioritize the needs and experiences of sites, like site enablement platforms. These platforms aim to reduce friction for sites and empower them to do more with less effort. The growing adoption of these technologies is evident in the rapid increase in the deployment of electronic investigator site files (eISFs) by sponsors. One of our surveys showed that in 2021, only 11% of sponsors reported deploying eISFs to study sites. 78% expect to by the end of 2023 (according to our 2023 survey that will be published soon). And 77% of sites already have an eISF, either from a sponsor or because they purchased one themselves. Sponsors will either deploy eISFs or use those already in place. Other site enablement technologies that are quickly reaching maturity include study startup (expected to be at 78% of sites by the end of 2023), eConsent (expected to be at 72% of sites), and eSource (expected to be at 72% of sites). While site enablement technology provides clear benefits to both sponsors and sites in terms of faster timelines and reduced costs, it also helps sponsors become “Sponsors of Choice” and sites become preferred sites. As such, it is expected that the use of these technologies will continue to grow in the coming years. Why does the technology landscape in clinical trial research get even more complex year after year? Having worked at a site for 20 years and having spoken to hundreds of sites over this past year, I can honestly say that the message from sites is clear - “we have too many technology platforms, and they’re not integrated.” I believe that this will have to shift in 2023 or the industry will risk widening the capacity gap – the gap of too many trials and too few site staff to run them. We know clinical trials are only growing more complex and diversity initiatives are pushing sites and sponsors to focus on increasing patient access, at the same time that staff turnover rates are at their highest. This introduces new challenges and risks for both sponsors and sites: New-to-research staff are hard to find and often don’t have sufficient training to handle complex study tasks right out the gate. Sites are becoming increasingly geographically dispersed, making it harder for CRAs to physically visit them on a regular basis. So to expand patient access, equip more sites to participate in research, and maintain compliance and oversight, we are seeing a massive influx of new technology vendors. Unfortunately, these vendors often design their solutions to meet the needs of only one side of the value chain: sponsor or site. This design failure results in a disconnected ecosystem of hard-to-use solutions. To solve these challenges, technologies must prioritize integrations and ease-of-use across stakeholder groups. This is what we are seeing happen now with the rising category of site enablement platforms. Platforms in this category understand the importance of solving for site needs to increase adoption and better connect sponsors and sites through collaborative data sharing. Because sites will have many studies, technology solutions have to be site-specific instead of study-specific to maximize value. We have to give sites options so that they can choose what technology works best for them and their patient populations, which means technology that can be easily adopted with minimal interruptions to workflows. Sites also need technology that allows sponsors and CROs to remotely access existing site data (i.e. eISF, CTMS, and eSource/EHR). How can we streamline overly complicated technology for patients and clinical trial participants? In 2023, we have to start by listening to clinical trial participants. We need patient advocates involved from the moment we begin planning trial protocols. And we need to give participants options. Patients, like all of us, have different levels of comfort with technology. Some patients may love submitting data online or through their phone. Some may be willing to use tech if they can get training from site staff on how to use it. And still others might prefer to visit the site in person, or to visit a frontier site like a pharmacy, clinic or primary care office. We need to listen to them and give them those choices.

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