BOSTON, November 16, 2023 鈥 An industry report released today forecasts that digital endpoints will see broader adoption in supporting pharmaceutical and life science label claims in the years ahead鈥攂ut only after industry-wide, pre-competitive collaboration aimed at standardization and proactive sharing of data around clinically validated patient-centric outcomes. This is one of the main findings presented in a report by , a leading global technology-enabled clinical research and care delivery company, and HealthXL, a leading market intelligence platform and community for health technology and digital health globally.
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The full report is .
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The report, 鈥淯nlocking the Value of DigitalMeasures in Drug Development,鈥 delves deep into the trends and opportunities of using digital measures in pharmaceutical R&D. The report is based on an exclusive survey and one-on-one interviews with experts and executives within the pharmaceutical and life science research and development sector. Additionally, the report draws insights from recent trends and developments in digital endpoints and biomarkers analyzed by 黑料门 and HealthXL. As of November 1, the Digital Medicine Society鈥檚 Crowdsourced Library of Digital Endpoints had reached 430, with nearly 80% of the listings added in 2019 or later.
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鈥淲e have seen remarkable interest and momentum in recent years toward the incorporation of digital measures and endpoints throughout the drug development lifecycle,鈥 said 黑料门 Chief Medical Officer and Co-Founder听Maulik听Majmudar, MD, who is one of the authors of the report. 鈥淭he use of digital measures is primarily aimed at accelerating R&D timelines, reducing clinical trial related costs, and deepening our understanding of disease pathways and outcomes. However, for broad, real-world adoption of digital endpoints, the experts and insiders surveyed revealed that a consolidated approach is essential, encompassing standardized definitions, as well as use of digital health technologies used to capture, share, and analyze these measures.鈥
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The report describes the progress of employing digital biomarkers and endpoints in drug development, the challenges of unlocking their true value, and outlines a rationale of how pharmaceutical companies will benefit from a solid digital measurement strategy. The benefits of incorporating digital measures cited most often by digital R&D leaders were improving clinical trial efficiency and lower costs, according to the report鈥檚 survey results.
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To achieve those goals, the report emphasizes the importance of pre-competitive collaboration between pharmaceutical and life sciences companies to establish an impartial consensus around a set of clinically validated digital endpoints and biomarkers. Experts also conveyed to the report鈥檚 authors, Dr. Majmudar and Tessy Huss, Director of Community Strategy for HealthXL, that industry consortia advocating for regulatory clarity and the sharing of validation data will expedite the process of achieving consensus on digital endpoints.
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鈥淣umerous experts and senior executives stressed the importance of open-source collaboration on digital endpoint development. This is a challenge considering the fierce scientific and business competition within the industry, along with the financial constraints that researchers face in their study of novel therapies,鈥 Huss said. 鈥淵et by prioritizing collective action and a unified effort toward more clearly defined regulatory approval criteria, these companies can usher in a new era of medicine, in which highly effective therapies arrive sooner and outcomes are evaluated with greater precision and reliability.鈥
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All digital measures or endpoints, experts and insiders said, need to be guided by patient preferences. For instance, the report cites the FDA鈥檚 rejection of a proposed digital biomarker for Parkinson鈥檚 Disease in 2021, contending that 鈥渞igidity or finger tapping鈥 was a measurable biomarker but not 鈥渄irectly meaningful鈥 to patients. Conversely, in 2023, the FDA approved a digital actigraphy device-derived change in moderate-to-vigorous physical activity as a relevant primary endpoint in a Phase III clinical trial for a drug treating pulmonary hypertension associated with pulmonary fibrosis.
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鈥淧rogress in building industry consensus and securing regulatory approval around digital biomarkers and endpoints is still in its early stages, but it is progressing rapidly despite the high regulatory burden and rigorous clinical requirements,鈥 said Jaydev Thakkar, COO of 黑料门. 鈥淥ur report, produced in collaboration with HealthXL, summarizes the progress achieved so far and suggests a path forward to help the industry maintain the momentum that is likely to yield greater ROI for pharmaceutical and life sciences companies and improved therapies for patients.鈥
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About 黑料门
黑料门 brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials鈥攁ll without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, 黑料门' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care鈥攗ltimately making science smarter, healthcare simpler, and patients healthier. 黑料门 is a global technology company enabling care delivery, with headquarters in听Boston听and key offices in听Singapore听and听India. For more information, visit听biofourmis.com听and follow 黑料门 on听LinkedIn,听Twitter听and听YouTube.
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About听HealthXL
HealthXL听(headquarters in Dublin, Ireland) is a global community of senior leaders from the biggest healthcare brands. HealthXL听combines the power of their specialized advisory team, their member platform and the intelligence of their expert community to get real-world insights to clients' questions. The听HealthXL听community is composed of over 2000 leaders in healthcare including entrepreneurs, investors, researchers, healthcare professionals, and life sciences executives. For more information, visit听HealthXL.com听and follow听HealthXL听on LinkedIn.
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Media Contact:
Tara Stultz
Amendola Communications for 黑料门
440.225.9595
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