Within CNS indications, data suggest Agile Clinical Trials™ and decentralized approaches will become more prevalent in 2022 and beyond
RESEARCH TRIANGLE PARK, N.C., March 01, 2022 (GLOBE NEWSWIRE) -- Science 37 Holdings, Inc. (Nasdaq: SNCE), the Agile Clinical Trial Operating System™, today published new CNS (Central Nervous System) therapeutic data validating the growing trend toward decentralization as two-thirds of CNS survey respondents plan to execute an agile or decentralized clinical trial in 2022, an increase of more than 35 percent from last year.
According to analysis, the CNS Research & Development spend will reach $32 billion USD by 2026, resulting in more than 4,000 clinical trials¹. To uncover these new trends in CNS clinical trials methodologies, Science 37 conducted a study of more than 70 clinical research executives, between December 2021 and January 2022.
“These insights confirm: agile designs and decentralized methods are the way forward to reduce the burden and enable more universal access for patients and providers, anywhere,” said Drew Bustos, Chief Strategy & Marketing Officer at Science 37, and co-author of How Agile Clinical Trials are Impacting CNS Research. “This report aligns with the shift we’re seeing from CNS sponsors and similar to the market overall. It’s encouraging as we strive toward creating more equitable access to clinical research with more and more patient-centric approaches.”
For CNS studies, survey respondents cited unexpected delays, data quality and limited patient populations among the key challenges for clinical trials, with effective patient recruitment as the single biggest challenge by more than 100% comparatively to the second challenge of endpoint collection. Being able to eliminate geographic barriers with agile and decentralized approaches and helping to ease patient burden can help alleviate these concerns and enable more efficient centralized enrollment into studies.
The new data and insights also paint a vivid picture of the clinical trials landscape for the year ahead for CNS studies, suggesting significant increases in agile and decentralized approaches across numerous conditions—including major depressive disorder, Alzheimer’s disease, and Parkinson’s disease—and executed with a myriad of permutations of patient communities, mobile nursing, telemedicine investigators and connected devices – further demonstrating the need for a centralized Operating System with unified technology and centralized networks to effectively execute.
Among the findings:
- Less than 60 percent of CNS respondents are planning to execute a traditional, site-based clinical trial in 2022, down from three in four for the previous year.
- Unexpected delays, data quality, and limited patient populations all ranked highly among the issues keeping respondents up at night, regarding CNS trials in general.
- Respondents cited the greatest single challenge of running an effective CNS study was patient recruitment by more than 100% comparatively to the second challenge of endpoint collection.
- Electronic clinical outcomes assessment (eCOA) and electronic patient-reported outcomes (ePRO) were cited as the most prevalent decentralized components in CNS, with two-thirds of CNS respondents planning to use these tools – showing the rising embrace of digital data collection and evidence generation.
- Among the largest-growing decentralized components of CNS studies cited were mobile nurses, up 40 percent and up 38 percent, respondents cited usage of Metasites™ or virtual sites that can enable more universal geographic coverage and access for patients.
- The three greatest perceived benefits of including agile and decentralized components in CNS clinical trials were increased patient retention (more than 55 percent), increased patient diversity and faster patient recruitment (both more than 50 percent).
You can download a copy of the full report for free at www.science37.com.
About Science 37
Science 37, Inc.’s (Nasdaq: SNCE) mission is to enable universal access to clinical research—making it easier for patients and providers to participate from anywhere and helping to accelerate the development of treatments that impact patient lives. As a pioneer of decentralized clinical trials, the Science 37 Clinical Trial Operating System (OS) supports today’s more agile clinical research designs with its full-stack, end-to-end technology platform and specialized networks of patient communities, telemedicine investigators, mobile nurses, remote coordinators and connected devices. Configurable to enable any study type, the Science 37 OS enables up to 15x faster enrollment, 28% better retention and 3x more diverse patient population with industry-leading workflow orchestration, evidence generation and data harmonization. For more information, visit https://www.science37.com.
About the Agile Clinical Trial:
The use of decentralized tools and methodologies is increasing. With these advances, patients will be able to participate from their home, a site, or a combination of home and site; and providers will be able to participate on or off-premise. This symbiotic clinical trial or the “Agile Clinical Trial” requires: The ability to activate any provider and any patient, regardless of premises; a network of patient communities, telemedicine investigators, mobile nurses, and remote coordinators—all with a flexible Operating System to seamlessly navigate between on-site and off-site.
Forward Looking Statements
This presentation contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the services offered by Science 37 Holdings, Inc. (“Science 37” or the “Company”) and the markets in which it operates, and Science 37’s projected future results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Science 37’s securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Science 37 plans to operate, variations in performance across competitors, changes in laws and regulations affecting Science 37’s business and changes in its capital structure, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional opportunities, (iv) the risk that Science 37 may never achieve or sustain profitability, (iii) the risk that Science 37 will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; and (v) the potential adverse effects of the ongoing global COVID-19 pandemic. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Amendment No. 2 to the S-1 Registration Statement filed by Science 37 with the U.S. Securities and Exchange Commission (the “SEC”) on January 20, 2022, and other documents filed by Science 37 from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Science 37 assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Science 37 does not give any assurance that Science 37 will achieve its expectations.
¹ Source: Evaluate Pharma
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