PALO ALTO, Calif.–(BUSINESS WIRE)–Medable Inc., the leading technology provider for modern clinical trials, achieved an impressive 75% adoption of its Total Consent solution deployed in elderly patient population in U.S. Renal Care’s (USRC) investigator-initiated trial. The Phase IV trial, funded by a top-10 global pharmaceutical company, had a narrow recruitment window to enroll patients suffering from Anemia in End Stage Kidney Disease (ESKD) across more than 40 dialysis centers, involving 476 site users.

With a patient demographic primarily composed of people aged 65+ and unfamiliar with electronic consent (eConsent), USRC needed an easy-to-use solution, flexible to be adapted to the unique needs of elderly participants. Medable delivered. In fact, participants reported they preferred Medable’s Total Consent experience over traditional paper-based consent.

“Medable Total Consent helped us to rapidly launch and successfully recruit for a large multisite clinical trial and thoroughly consent a traditionally technology-averse demographic,” said Geoffrey A. Block, MD, Associate Chief Medical Officer and SVP of Clinical Research and Medical Affairs at U.S. Renal Care. “The product was straightforward to use, and its training demo modules made it easy to implement. Innovative and flexible, Medable Total Consent helps our industry move beyond simply relying on traditional paper consents.”

Total Consent allows participants to consent onsite or remotely, with eSignature or wet ink signature, increasing patient satisfaction by providing optionality. It can be tailored for use across over 115 locales in compliance with local regulatory requirements. In fact, its flexibility enabled USRC to suddenly expand recruitment mid-trial to Spanish-speaking populations. In less than two weeks, Medable added language translations and custom Spanish materials.

Enhanced eConsent solutions, such as Total Consent, that incorporate various digital elements (i.e., interactive videos, collapsible summaries, and knowledge checks) are poised to become the gold standard. Medable and Duke BASE labs compared enhanced eConsent against text-only eConsent across 24 patients and found 71% of patients preferred the enhanced solution, saying it made the process more engaging, informative, and humanized. Another study of the consenting process of 35 clinical trials (representing 13,200+ participants) found patients using eConsent versus paper had a better understanding of the trial information.

“Digital technology can be perceived as less personal, so we were surprised to learn that the digital enhancements to eConsent had a personal impact on participants and may help improve the consenting process in trials,” said Amy Corneli, PhD, Director of the BASE Lab and an Associate Professor in Duke’s the Department of Population Health Sciences.

“People sometimes jump to the conclusion that the elderly population is intimidated by technology, but well-designed technology is proving to help this demographic, and many even prefer it over paper,” said Dr. Pamela Tenaerts, Chief Scientific Officer at Medable. “Total Consent improves the experience for all participants plus it’s easy for sites to deploy even in large, multidimensional trials like with USRC. It removes friction for both patient and site.

Medable, which ranked in the top 8% of software companies on the 2023 Inc. 5000, has deployed its software-as-a-service platform in more than 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally. Customers have achieved impressive results – including 200 percent faster enrollment and 50 percent cost reductions. A Tufts Center for the Study of Drug Development study shows that, on average, decentralized trials can achieve net financial benefits from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI for an investment on average of $500K in Phase II and $1.5M in Phase III trials, respectively.

About Medable

Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Named a Leader in the industry by Everest Group and awarded Best Digital Health Solution by the Galien Foundation, the Medable platform has been deployed in more than 300 trials in 60 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and ranked #398 on the Inc. 5000 in 2023.

Contacts

Lisa Barbadora, Barbadora INK for Medable
+1 (610) 420-3413
lbarbadora@barbadoraink.com / media@medable.com

Key Findings

• Diagnostic Accuracy Boosted with Standard AI Models: Clinicians experienced a significant increase in diagnostic accuracy by 4.4% when provided with standard AI model predictions and explanations compared to baseline accuracy.
• Systematically Biased AI Models: However, the study revealed alarming results when clinicians encountered systematically biased AI model predictions. Diagnostic accuracy plummeted by 11.3%, indicating the detrimental impact of biased AI on clinical decision-making.
• Ineffectiveness of Explanations for Systematic Bias: Notably, the study found that commonly used image-based AI model explanations did not mitigate the negative effects of systematically biased AI predictions. Clinicians were not able to recognize and correct errors induced by biased models, emphasizing the need for further research and refinement in AI model explanations.

Study Details

• Participants: The study involved hospitalist physicians, nurse practitioners, and physician assistants across 13 US states.
• Methodology: The study employed a randomized clinical vignette survey, conducted between April 2022 and January 2023, presenting clinicians with nine clinical vignettes of patients hospitalized with acute respiratory failure. Clinicians were tasked with determining the likelihood of specific underlying causes based on presenting symptoms, physical examinations, laboratory results, and chest radiographs.
• Interventions: Clinicians were randomized to assess clinical vignettes with or without AI model input, including explanations. Both standard and systematically biased AI model predictions were tested.
• Outcomes: Diagnostic accuracy for pneumonia, heart failure, and chronic obstructive pulmonary disease was measured.

Implications

This study underscores the potential of AI to enhance diagnostic accuracy in clinical settings. However, the findings highlight the urgent need to address systematic biases within AI models, which can compromise patient care and clinical decision-making.

The ineffectiveness of current image-based AI model explanations suggests the need for additional research and the development of more robust strategies to mitigate biases in AI systems.

Conclusion

While standard AI models show promise for improving diagnostic accuracy, the presence of systematic bias poses significant challenges to their clinical utility. As healthcare increasingly integrates AI technologies, it is imperative to ensure the reliability and fairness of these systems to safeguard patients.

This study marks a critical step forward in understanding the complex interplay between AI and clinical practice, paving the way for future advancements in AI-driven healthcare.

Solution Creates New Mechanism for Clinicians and Patients to Engage in Clinical Research

SAN FRANCISCO–(BUSINESS WIRE)–Verana Health®—a digital health company elevating quality in real-world data (RWD)—today announced the launch of VeraSite, a solution for identifying potential clinical trial sites. The new subscription-based tool offers clinical trial sponsors and contract research organizations (CROs) a secure way to quickly identify practices with clinical expertise and potential patient populations matched to unique study protocols. This data can guide site selection, ensuring sponsors and CROs are selecting sites that better align with study goals. Sponsors will have the ability to connect directly with practices that agree to have contact information displayed in the tool, allowing researchers to gauge interest in participating in, or referring patients to the trial. Verana Health can also reach out to consenting practices on the sponsor’s behalf to make introductions, expanding access to new patient populations.

Drawing on de-identified real-world electronic health record (EHR) data from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight), VeraSite delivers a comprehensive, real-time summary of real-world ophthalmology patient populations, enabling more targeted, patient-centric clinical trial design. Additional site-level information, such as trial experience, sub-specialties and clinical areas of interest, are used to match investigators to upcoming clinical trials. This detailed view of the entire ophthalmology patient population gives clinical trial sponsors and CROs the ability to design a site strategy based on real-world patient data, and broadens access to new clinical trials for clinicians and patients.

“Globally, more than 80% of trials fail to meet enrollment deadlines, resulting in costly extensions, addition of new study sites, or outright study failure. That is simply not an acceptable level of efficiency,” said Andrea Sim, Verana Health’s Chief Product Officer. “With VeraSite, we’ve created a real-world evidence-driven solution to that challenge, allowing sponsors and CROs to optimize site selection based on a complete view of the entire patient landscape. This is an enormous step forward in improving efficiency and diversity in ophthalmology clinical trials, and it opens up tremendous new opportunities for clinicians and patients to become more involved in clinical trials.”

Verana Health is the exclusive data curation and analytics partner for the IRIS Registry, one of the largest specialty society clinical data registries in all of medicine, containing de-identified longitudinal patient data collected from more than 15,000 contributing clinicians. Refreshed monthly, this dataset provides comprehensive, timely insights into potential study participants, allowing organizations to make faster, more accurate site selection decisions. Leveraging artificial intelligence, such as natural language processing and advanced machine learning, Verana Health is able to extract and organize both structured data (e.g., diagnosis and procedural codes) and unstructured data (e.g., clinician notes and images) from this expansive dataset.

VeraSite puts this powerful real-world patient data analytics capability to work, helping clinical trial sponsors and CROs identify the optimal research sites. Users of the tool are able to identify different patient groups according to parameters such as specific diagnoses, patterns of treatment, visual acuity results, intraocular pressure, and demographics. This process takes only a couple of minutes and the data itself is refreshed regularly to deliver accurate patient and participating practice information. Once these filters are applied, the names of participating practices will appear along with counts of suitable patients for the trial.

For more information on VeraSite, please visit: https://www.veranahealth.com/data-and-technology/verasite/

About Verana Health

Verana Health® is a digital health company elevating quality in real-world data. Verana Health operates an exclusive real-world data network of more than 20,000 healthcare providers (HCPs) and about 90 million de-identified patients, stemming from its strategic data partnerships with the American Academy of Ophthalmology®, American Academy of Neurology, and American Urological Association. Using its clinician-informed and artificial intelligence-enhanced VeraQ® population health data engine, Verana Health transforms structured and unstructured healthcare data into curated, disease-specific data modules, Qdata®. Verana Health’s Qdata helps power analytics solutions and software-as-a-service products for real-world evidence generation, clinical trials enablement, HCP quality reporting, and medical registry data management. Verana Health’s quality data and insights help drive progress in medicine to enhance the quality of care and quality of life for patients. For more information, visit www.veranahealth.com.

Contacts

Rachel Ford Hutman
Ford Hutman Media
Rachel@fordhutmanmedia.com
(301) 801-5540

TORONTO & LAUSANNE, Switzerland & NEW YORK–(BUSINESS WIRE)–Altis Labs, Inc. (“Altis”), the computational imaging company accelerating clinical trials with artificial intelligence, today announces the closing of its US $6 million seed financing. Benchstrength and Debiopharm Innovation Fund co-led the round with participation from strategic angels including Doug Foster, the former CEO of digital health company Verana Health, and Richard Gliklich, MD, the founder and CEO of real-world data company OM1.

“We are thrilled to partner with Benchstrength and Debiopharm,” said Felix Baldauf-Lenschen, Co-Founder and CEO of Altis. “This partnership will help us execute on our mission to reduce the excessive time and cost it takes to bring novel, effective treatments to patients in need.”

Medical imaging accounts for 90% of all healthcare data. Altis was founded with the belief that imaging is the richest source of clinical data but is vastly underutilized. Reductionist interpretation guidelines developed over 40 years ago are known to over- and underestimate clinical benefit [1, 2, 3], thereby limiting clinicians’ ability to measure how well cancer treatments work.

Trained on the world’s largest proprietary cancer imaging database with longitudinal clinical context, the company’s state-of-the-art deep learning models predict clinical endpoints to help quantify treatment effect beyond simplistic and subjective tumor size measurements.

Funding will be used to scale the development of Nota, Altis’ AI-powered imaging biomarker platform, across solid tumor types and therapeutic areas. Leading biopharma companies like Bayer Pharmaceuticals use Nota to analyze imaging data from phase 1-3 clinical trials in a more meaningful way.

“In R&D, imaging is a core component of what we do in clinical trials and current methods don’t exploit its full potential,” said Carolina Haefliger, MD, Head of Translational Medicine at Debiopharm and Board Observer at Altis. “We believe that AI-powered tools, such as those developed by Altis, will become the new standard for measuring clinical benefit not just in clinical trials, but also in clinical care.”

Altis hosts proprietary prognostic models in the Nota cloud platform for biopharma R&D teams to automatically analyze clinical trial imaging data. Model predictions allow researchers to more accurately stratify patients at baseline and measure treatment effect across subpopulations. These insights help sponsors generate higher quality evidence earlier in clinical development to increase success rates in late-stage trials and inform critical R&D decisions spanning go/no-go, trial design, reimbursement strategy, and revivals of shelved assets.

“It’s clear that AI will have a significant impact across healthcare, but Altis is uniquely positioned to transform the economics of clinical development,” said Kenneth Chenault, Managing Partner at Benchstrength and Board Director at Altis. “The Altis team has curated an unparalleled clinical imaging database in terms of both depth and breadth, which they are translating into actionable clinical insight thanks to their AI models.”

“This milestone for Altis is a testament to Canada’s leading role in both AI and clinical research” said Sally Daub, Co-Founder and Board Chair at Altis. “Our goal is to accelerate therapeutic development and improve the standard of care.”

Altis’ imaging-based prognostication (IPRO) technology has been validated in collaboration with Canada’s leading cancer centers, with results published in the Journal of Clinical Oncology – Clinical Cancer Informatics [4] and presented at the American Society of Clinical Oncology [5, 6].

About Altis Labs

Altis Labs is the computational imaging company advancing precision medicine. We believe that medical imaging is the richest source of untapped clinical insight. Biopharma companies use our software platform, Nota, to accelerate and de-risk all stages of clinical development. Trained on over 182 million real-world images with associated diagnostics, treatment information, and outcomes, Nota predicts clinically meaningful outcomes from baseline and follow-up scans to more accurately stratify patients and quantify treatment effect. Altis is proudly based in Toronto, Canada.

To learn more, visit altislabs.com or email info@altislabs.com.

About Benchstrength

Benchstrength is an early stage venture capital firm focused on investing in technology companies that transform business and uplift communities. Based in NYC, Benchstrength invests in software and technology-enabled businesses across enterprise, consumer, fintech, and healthcare. The firm is committed to building, cultivating, and re-architecting networks in a way that expands access to opportunity and builds a more diverse, equitable, and inclusive entrepreneurial ecosystem.

Debiopharm Innovation Fund

Debiopharm Innovation Fund, the strategic investment arm of Swiss biopharmaceutical company Debiopharm, provides funding and guidance for companies with an ambition to improve the patient journey and transform pharmaceutical R&D. Since 2017 Debiopharm has invested in 20 AI and digital health companies, typically leading the investment rounds.

For more information, please visit www.debiopharm.com/digital-health/

References

For more information, please visit www.debiopharm.com/digital-health/

Contacts

Contact Debiopharm
Dawn Bonine
Head of Communications
dawn.bonine@debiopharm.com
Tél. : +41 (0)21 321 01 11

Sleep disorders (including insomnia) are mostly treated with Cognitive Behavioral Therapy (CBT-I). In China, traditional face-to-face CBT-I therapy isn’t practical, due to the overwhelming number of insomnia patients, the time-consuming process, and the relative shortage of professional therapists.
In the past decade, self-service digital CBT-I applications (apps) for insomnia patients have been developed and proven effective in Western countries.

A clinical trial to analyse digital treatments for insomnia

According to a single-blind randomized clinical trial, conducted from March 2021 to January 2022, Chinese culture-adapted DCBT-I improves insomnia severity more than sleep education.
Screening and randomization were carried out at Peking University First Hospital with follow-up visits also being performed there or online.

After assessing eligibility, they formed sleep education groups and a DCBT-I group in a 1:1 ratio according to random numbers. The collected data were analyzed in the first months of 2022.

More info on the clinical trial can be found here

Interventions, outcomes and measures

In both of the groups (DCBT-I and sleep education), the participants had access to a Chinese smartphone-based application for 6 weeks, with follow-ups at 1, 3 and 6 months.

Participants in the DCBT-I (intervention group) received a 6-week self-guided DCBT-I, supplied with a smartphone application called resleep, which included sleep hygiene education, stimulus control, relaxation therapy, sleep restriction, and cognitive therapy.
The other participants (control group) received sleep hygiene education and stimulus control information, with relevant content that overlapped with the corresponding modules of the DCBT-I.

Insomnia Severity Index (ISI) score was the primary outcome using the intention-to-treat principle. Secondary and exploratory outcomes included sleep diary measures; self-reported scales assessing dysfunctional beliefs about sleep, mental health, and quality of life; and smart bracelet measures.

There were 97 total individuals screened for eligibility, of whom:

• 6 had an ISI of 14 or less;
• 3 had insomnia for less than 3 months;
• 4 were engaged in night shifts;
• 1 reported comorbid cancer;
• 1 was not present for screening after enrollment;
• 82 were assigned equally to the sleep education and DCBT-I groups;
• 5 did not complete the 6-week treatment;
• 1 did not complete the 1-month follow-up;
• 1 did not complete the 3-month follow-up;
• 2 did not complete the 6-month follow-up.

The 6 weeks program was completed by only 77 participants, which were included in the full analysis data set.

Conclusions

The app reduced the severity of insomnia and improved the quality of sleep. This result suggests that culturally adapted DCBT-I is suitable for the large population of patients with insomnia in China. Although, there’s a need for large multicenter trials to validate the effectiveness of this treatment in Chinese populations.

Drug development process questions the reliability and accuracy of DHT products. FDA has formed a steering committee consisting of its drug, device, and biologics review centers to ensure consistency. Additionally, it has created two centres of excellence: one for digital health, one for oncology.

The agency says it will review and evaluate DHT-related data, hire more people with the right expertise, and examine IT capabilities required for DHT use.

FDA plans to convene five public meetings to discuss DHTs use in clinical trials. The meetings will explore topics such as what to prioritize when developing DHTs, and what approaches to take when verifying and validating DHTs.

The FDA has issued several draft guidelines on DHT use in clinical trials, but there are concerns about whether the plan will address the biggest issues faced by the medical product development industry.
There is hope that the agency will develop consistent policies across CDER and CDRH reviews and not just within CDER.

More details at https://www.raps.org

BOSTON–(BUSINESS WIRE)–#clinicalresearch–YonaLink, a clinical trial software provider, today announced its EHR-to-EDC data integration platform has been implemented by Hadassah Medical Organization (HMO) in Jerusalem. Recognized worldwide for setting the standard of excellence for medical care and research in Israel, Hadassah is leveraging YonaLink’s SaaS solution to stream and map up-to-date, real-time patient data directly from electronic health record (EHR) systems to electronic data capture (EDC) systems, enabling greater speed, quality, and efficiency in clinical trial data collection.

Every year, Hadassah initiates close to 500 new clinical trials and publishes more than 1,000 research studies in peer-reviewed, scientific publications. The partnership with YonaLink is part of Hadassah’s larger focus on driving innovation in medical research and making Hadassah and Israel hubs for global clinical trials across therapeutic areas, ensuring the continued delivery of tomorrow’s cutting-edge treatments to patients today. Using YonaLink’s technology will enable Hadassah to partner with clinical trial sponsors and research stakeholders around the world and expand access to the medical center’s R&D capabilities led by physicians and scientists renowned for developing novel therapeutics, diagnostics, and devices that are improving outcomes and quality of life for patients.

“In recent years, more than 50 percent of the Israel Science Foundation (ISF) grants, awarded personally, for biomedical research in Israeli hospitals were given to Hadassah, in addition to the hundreds of international clinical trials we are part of at Hadassah. Given this growth in research activities, solutions that can help reduce resource constraints, costs, and other inefficiencies are vital,” said Professor Eyal Mishani, General Director, Research Fund of the Hadassah Medical Organization. “YonaLink provides Hadassah with a cutting-edge tool that can seamlessly work across any EHR, making it possible for data to effortlessly flow to trials and registries across Israel and all over the world. This reduces the burden on our study teams and improves data quality by eliminating the need for redundant, error-prone processes involved in duplicating data for clinical trial EDCs.”

For decades, automating the transfer of patient data from EHRs to EDCs has been a major pain point in clinical trial operations because of the lack of data reconciliation, complexity of systems integration, and abundant interoperability gaps. YonaLink solves these challenges, eliminating dependence on manual processes and “swivel chair interoperability.” The company’s platform provides the capabilities to stream up-to-date data from any clinical site’s EHR system, in any part of the world, and populate it within YonaLink’s next-generation EDC. With built-in eConsent and ePRO / eCOA and streaming EHR-to-EDC capabilities, YonaLink’s next-generation EDC provides a comprehensive, scalable solution for today’s clinical trial needs, bringing EDC and eSource functionality together in a single tool.

“Hadassah has more than earned its reputation in Israel and around the world as a leading center of excellence, and we’re thrilled to be partnering with them to fuel innovation in clinical trials,” said Itai Rechnitz, YonaLink’s COO and Co-Founder. “Simplifying data collection to integrate care with research is critical to moving clinical trials forward and enabling progress, and it will help Hadassah accelerate learning and improve patient care on a continuous and global basis.”

About Hadassah Medical Organization (HMO) and Hadasit

For more than a century, Hadassah Medical Organization (HMO) has set the standard of excellence for medical care and research in Israel. Our doctors and scientists are on the front lines, uniquely positioned to pinpoint ever-evolving medical needs. Their experience and ingenuity have yielded new ideas with huge potential in all areas of medicine, including therapeutics, diagnostic medical devices, and digital health.

About YonaLink

YonaLink equips research teams with the ability to extract up-to-date patient data from an EHR and stream that data into a clinical trial electronic data capture (EDC) system in real time, reducing clinical trial timelines and costs. Headquartered in Boston with R&D operations in Israel, YonaLink is bringing new levels of speed, quality, and efficiency to clinical trial operations across the globe, simplifying the complexity of clinical data collection and validation, and enabling true scalability. The Company’s SaaS platform has the capabilities to stream up-to-date data from any clinical site’s EHR platform, in any part of the world, and populate it within YonaLink’s next generation EDC. With built-in eConsent and ePRO / eCOA and streaming EHR-to-EDC capabilities, YonaLink’s next generation EDC provides a comprehensive solution for today’s clinical trial needs, bringing EDC and eSource functionality together in a single tool that can be set up within minutes, eliminating integration delays, reducing costs, and accelerating study timelines. Learn more at www.yonalink.com.

Contacts

Sari Holtz
Marketing Manager
sari.h@yonalink.com
+1-914-775-5538
+972-54-680-1550

We are very excited to share the great results of the Orion Corporation Clinical Trial where Healthware was the key R&D partner creating a Digital Therapeutics solution (DTx) for chronic pain patients.

A novel treatment, a Digital Therapeutics software solution for Chronic Pain (DTxP), using Virtual Reality (VR), has shown statistically significant benefit over passive (placebo) control and standard care interventions for fear of movement, patient clinical global impression of change (PGIC) and quality of life in adult patients with chronic low back pain (CLBP). Results from the pilot study were announced at the IASP 2021 Virtual World Congress On Pain.

Background: Growing opportunities with Virtual Reality

The results from this clinical trial are very positive, and it also gives hope to find a way to bring this solution to the people with chronic pain who need it. In the future we will likely see more of these kinds of solutions being developed, also for other kinds of therapies and treatments.

Read the full article by Therese Elg, Marketing & Communications Director Nordics & Baltics, Healthware International, at www.healthwaregroup.com/blog