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Findings from Florence Healthcare’s State of Clinical Trial Technology Industry survey about how clinical operations technology changed in 2020 and how they expected it to evolve throughout this year.
In December 2020, more than 230 clinical trial sites, sponsors, and contract research organizations completed Florence Healthcare’s State of Clinical Trial Technology Industry survey1 about how clinical operations technology changed in 2020 and how they expected it to evolve in 2021. As we quickly approach the mid-year mark of 2021, it’s clear that the responses revealed several significant trends that are as impactful and true today as they were at the end of 2020.
These trends will continue to shape the industry in the future. Sponsors, CROs, sites and technology providers should understand them in order to run safer and more efficient clinical trials—and perhaps even discover more treatments and cures.
In the survey, 47% of clinical trial sites and 36% of sponsors said they increased their spending on technology in 2020. When asked why they invested more heavily in tech, 64% of sites and 71% of sponsors and CROs said it was because of the need for remote work during the COVID-19 pandemic.
When non-patient-facing personnel began to work remotely, many sponsors and clinical trial sites discovered that essential documents weren’t available online. A handful of employees had to rush to find, scan and upload paper study documents, slowing down trials. In some instances, sites were completely closed and there were significant delays in being able to access critical documents. Given these experiences, it’s not surprising that 87% of sponsors claim they invested in technology to eliminate paper records.
Clinical operations software is used for more than storing study documents. 76% of sponsors said they conducted most of their clinical trial monitoring remotely in 2020, while only 18% of monitoring took place remotely in 2019. Though this dramatic spike was caused by the pandemic, most sponsors, CROs, and clinical trial sites expect the trend to continue. In fact, 83% of sponsors and 80% of sites believe most clinical trial monitoring will be remote by 2023. With remote monitoring becoming more mainstream, choosing a secure, compliant software service or confirming that current services are compliant will be a priority for many sites in the next three years.
Although many clinical trial sites and sponsors had already begun to embrace technology for electronic recordkeeping and remote monitoring before the pandemic, the significant uptick in technology use last year came with its own set of challenges. Some sites had to adopt software quickly to participate in COVID studies or to allow remote work. With less time to evaluate vendors, sites and sponsors risked using software that didn’t integrate well with their existing processes or that didn’t meet all security and compliance regulations. As the COVID-19 pandemic ends, and FDA inspections return to a normal cadence, compliance could quickly become a concern for some organizations.
To ensure compliance in the future, sites and sponsors need to select software providers that can learn about and comply with varied global regulations and protocols. Further, the survey suggests that post-COVID, sponsors and sites will move away from last-minute or emergency software vendors and instead choose vendors that are intimately familiar with life sciences, clinical trials, and FDA, GDPR, and HIPAA regulations.
90% of clinical trial sites in the survey invested in technology to increase their chances of being chosen for a study, as sponsors prefer sites with secure, compliant electronic records. Clinical trial software can save time, minimize mistakes and handoffs, make it easier for sponsors to oversee all of the sites they’re working with, and even encourage patient participation by allowing participants to conduct some study activities remotely.
However, the wrong technology can cost clinical trial sites time and money, result in low user adoption, and limit which workflows can be integrated. In a worst-case scenario, the software may have to be removed and replaced. Therefore, in 2021 and beyond, sites and sponsors will search for software that 1. Is worth the investment, 2. Makes sense to all users in the clinical trial ecosystem (including participants), and 3. Accommodates a variety of workflows.
68% of sites worry about their budget to buy technology, and purchasing the wrong software can make it difficult to convince your team to invest in technology in the future. Software vendors with a site-first mindset can help determine which software features the site needs to support a strong ROI.
In the future, clinical trial technology will need to focus on proven site and user adoption. 48% of sites worry about integrations when incorporating new software, and 40% have concerns about transitioning to new technology. On the employee side, it helps to choose a software provider who offers thorough training during the implementation stage and excellent customer support afterward. Sites and sponsors will also need to consider participant interactions, choosing software that is user-friendly so that trial participants don’t find electronic processes more overwhelming than paper ones.
In 2021, many clinical trial sites look forward to adding functionality to their electronic Investigator Site File (eISF) platforms. 65% of sponsors and sites surveyed plan to have a purpose-built eISF platform with additional workflows layered on top of it. 47% of those sites want to use electronic consent forms, while 37% want to use technology to manage source data. Clinical trial technology providers will need to offer varied workflows as part of a single software to remain competitive.
2020 dramatically changed the landscape for clinical trial technology, with many sponsors and sites rushing to adopt software to support decentralized trial processes with remote monitoring and electronic recordkeeping. In 2021 and beyond, sponsors, CROs, and trial sites will continue to embrace technology but will do so more carefully, considering concerns about compliance, workflow, budget, and adoption. The clinical trial technology industry will need to adjust accordingly and offer well-regulated, versatile, and user-friendly software that CROs, sponsors, and sites can effectively leverage for years to come.
Andrea Bastek is the Director of Innovation for Florence Healthcare