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The Growing Case for Digital Therapeutics

Exceedingly broad in scope, digital health includes mobile health (mHealth), telehealth and telemedicine, consumer wearable devices that track user activity and monitor vital signs such as heart rate, patient portals and personalized medicine. The vast amounts of data collected by digital devices, along with the analytics platforms, artificial intelligence (AI) and machine learning that make sense of that data, today are being used to support clinical decisions and guide public health policies.

“Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of healthcare for the individual,” the Food and Drug Administration (FDA) writes. The Agency has been very supportive of digital health, creating the Digital Health Center of Excellence (DHCoE) in the fall of 2020 to provide regulatory advice and support to the FDA’s regulatory reviews and to create a network of partnerships to advance and realize the potential of digital health technologies.

An emerging field in which digital tools are being used in healthcare is digital therapeutics (DTx), where software-based interventions are used to treat, manage, or prevent a disease or disorder. Today DTx companies are gathering evidence through clinical trials, studies of real-world evidence (RWE), claims data and other relevant sources and then apply for approval or clearance to the FDA’s Center for Devices and Radiological Health or other global regulatory agencies. The global DTx market is projected by Allied Market Research to reach a value of $23.6 billion by 2030, more than six times the 2020 value of $3.6 billion.

DTx have been developed to address a wide range of physical and mental health issues. There are products that deliver cognitive behavior therapy, improve medication adherence, regulate insulin doses, cope with opioid use disorder, manage musculoskeletal pain and deal with insomnia.

Unique Challenges

Non-digital products are approved by the FDA in a final form, such as a pill. Should a pharmaceutical company make changes to that pill, it would have to gain approval by the FDA once again to bring it to market. But many DTx products change over time because they adapt to users. For example, Akili Interactive markets a prescription DTx video game, EndeavorRX, for children with ADHD. The game adapts to players as they use it. So Akili must evolve the gameplay experience by adding new features and functionality to retain its effectiveness as a treatment. This requires a new process for approving products that could include a pre-certification process with support from the DHCoE and then submission of clinical evidence to gain FDA approval or clearance. The challenge here is that even if a DTx company wins regulatory approval or clearance, there is no guarantee that payers are going to provide reimbursement. They may conclude that there is insufficient evidence to support the coverage of a particular product.

To accelerate the adoption and integration of DTx into healthcare, the non-profit Digital Therapeutics Alliance (DTA) was formed in 2017 by DTx technology manufacturers from around the world. Since its inception, DTA has grown to more than 70 members. Among those supporting DTA is Curebase, which recently announced a research and education partnership designed to help DTx organizations conduct effective clinical trials.

Shifting mindsets

If anything, digital therapeutics manufacturers are being held to almost a higher standard than some of the drug companies because there isn't standardization around what kind of clinical evidence applicants must provide to have their products accepted by both regulators and payers. This is part of the reason why some DTx companies are trying to go direct to patients or working with employers to provide DTx treatments to employees. These routes, however, present their own challenges.

While the list of DTx treatments approved by the FDA and other regulatory agencies around the world continues to grow, much work remains to establish industry expectations and educate regulators, DTx vendors, payers and providers. It’s still hard for many people to grasp that software itself can be the treatment.

Shifting mindsets isn’t easy. Persuading regulators, payers, providers and patients about the effectiveness of DTx will take time and evidence in the form of studies that include real-world data and results. Fortunately, that evidence is growing daily.

About the author: For more than a decade, Adam Samson has helped to conduct clinical trials across multiple therapeutic areas within academia, sites, CROs, pharma, and tech. He currently serves as the senior director of clinical operations and customer success at Curebase, a software and services provider purpose-built for decentralized clinical trials (DCT). Samson also serves as adjunct faculty at The George Washington University in the Master's in Clinical Research Administration program.

About Curebase

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.


Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

Related Links:

Original Article

SOURCE Healthcare Business News

The Growing Case for Digital Therapeutics

Exceedingly broad in scope, digital health includes mobile health (mHealth), telehealth and telemedicine, consumer wearable devices that track user activity and monitor vital signs such as heart rate, patient portals and personalized medicine. The vast amounts of data collected by digital devices, along with the analytics platforms, artificial intelligence (AI) and machine learning that make sense of that data, today are being used to support clinical decisions and guide public health policies.

“Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of healthcare for the individual,” the Food and Drug Administration (FDA) writes. The Agency has been very supportive of digital health, creating the Digital Health Center of Excellence (DHCoE) in the fall of 2020 to provide regulatory advice and support to the FDA’s regulatory reviews and to create a network of partnerships to advance and realize the potential of digital health technologies.

An emerging field in which digital tools are being used in healthcare is digital therapeutics (DTx), where software-based interventions are used to treat, manage, or prevent a disease or disorder. Today DTx companies are gathering evidence through clinical trials, studies of real-world evidence (RWE), claims data and other relevant sources and then apply for approval or clearance to the FDA’s Center for Devices and Radiological Health or other global regulatory agencies. The global DTx market is projected by Allied Market Research to reach a value of $23.6 billion by 2030, more than six times the 2020 value of $3.6 billion.

DTx have been developed to address a wide range of physical and mental health issues. There are products that deliver cognitive behavior therapy, improve medication adherence, regulate insulin doses, cope with opioid use disorder, manage musculoskeletal pain and deal with insomnia.

Unique Challenges

Non-digital products are approved by the FDA in a final form, such as a pill. Should a pharmaceutical company make changes to that pill, it would have to gain approval by the FDA once again to bring it to market. But many DTx products change over time because they adapt to users. For example, Akili Interactive markets a prescription DTx video game, EndeavorRX, for children with ADHD. The game adapts to players as they use it. So Akili must evolve the gameplay experience by adding new features and functionality to retain its effectiveness as a treatment. This requires a new process for approving products that could include a pre-certification process with support from the DHCoE and then submission of clinical evidence to gain FDA approval or clearance. The challenge here is that even if a DTx company wins regulatory approval or clearance, there is no guarantee that payers are going to provide reimbursement. They may conclude that there is insufficient evidence to support the coverage of a particular product.

To accelerate the adoption and integration of DTx into healthcare, the non-profit Digital Therapeutics Alliance (DTA) was formed in 2017 by DTx technology manufacturers from around the world. Since its inception, DTA has grown to more than 70 members. Among those supporting DTA is Curebase, which recently announced a research and education partnership designed to help DTx organizations conduct effective clinical trials.

Shifting mindsets

If anything, digital therapeutics manufacturers are being held to almost a higher standard than some of the drug companies because there isn't standardization around what kind of clinical evidence applicants must provide to have their products accepted by both regulators and payers. This is part of the reason why some DTx companies are trying to go direct to patients or working with employers to provide DTx treatments to employees. These routes, however, present their own challenges.

While the list of DTx treatments approved by the FDA and other regulatory agencies around the world continues to grow, much work remains to establish industry expectations and educate regulators, DTx vendors, payers and providers. It’s still hard for many people to grasp that software itself can be the treatment.

Shifting mindsets isn’t easy. Persuading regulators, payers, providers and patients about the effectiveness of DTx will take time and evidence in the form of studies that include real-world data and results. Fortunately, that evidence is growing daily.

About the author: For more than a decade, Adam Samson has helped to conduct clinical trials across multiple therapeutic areas within academia, sites, CROs, pharma, and tech. He currently serves as the senior director of clinical operations and customer success at Curebase, a software and services provider purpose-built for decentralized clinical trials (DCT). Samson also serves as adjunct faculty at The George Washington University in the Master's in Clinical Research Administration program.

About Curebase

At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.


Media Contact:

Shawn Malloy

media@curebase.com

315-882-5310

Related Links:

Original Article

SOURCE Healthcare Business News

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Entire article

Curebase and BEKHealth Join Forces to Expand Access to Decentralized Clinical Trials

Curebase to Leverage BEKHealth's Integrated Clinical Research Platform to More Easily Find and recruit Decentralized Trial Participants, Expand into Oncology and New Therapeutic Areas

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The digital therapeutics revolution is happening and Big Pharma is buying in — with caution

Companies like Pfizer, Novartis, Sanofi and BMS are diving into the world of digital therapeutics while recognizing the limitations of the young field.

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How Digital Health Solutions Can Address Shortages in Mental Healthcare

An online mental health provider and a provider of decentralized clinical research teamed up to build an app that may offer a digital health solution to address provider shortages in mental healthcare.

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Expanding decentralized clinical trials demands flexibility

It's important to be creative when overcoming obstacles to access to wider improvements in trial design and participation, says Jane Myles, VP of clinical trial innovation at Curebase.

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Health app companies wrestle with how to design studies to prove treatments work

For companies that have spent years developing interactive technologies to help treat disease, the tricky question inevitably comes: How far are you willing to go to prove it works?

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Curebase partners with Meru Health for 3-year mental health trial

Curebase signed a three-year clinical trial with Meru Health

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Curebase and Meru Health to Partner on Clinical Research for App-based Mental Health Treatment Program

Curebase and Meru Health announce partnership on three-year clinical trial.

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Curebase Names Digital Infrastructure Veteran Matt Lanier as VP of Engineering

Curebase welcomes Matt Lanier as VP of Engineering

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Y Combinator Top Private Companies - 2022

Y Combinator released its list of top companies for 2022, this year Curebase was featured in the list of Top Private Companies.

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Curebase Names Medical Research Veteran Sean Lynch as VP of Clinical Operations

Curebase welcomes Sean Lynch as Vp of Clinical Operations

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Curebase Hires Healthcare Attorney Laura Podolsky to Head Legal Team

One of the first attorneys to specialize in DCTs, Laura Podolsky, joins Curebase as General Counsel.

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Curebase Hires Alan Sun as Vice President of Product

Alan Sun brings his passion for finding solutions that improve patient outcomes as Curebase's new VP of Product

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Curebase Releases enhanced Patient App add-on option to all studies to universally better patient participation and choice

User-friendly clinical trial solution design to increase participant engagement

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Curebase Hires HR Veteran Andi Seymour as VP of People

Andi Seymour brings over 15 years of progressive and hands-on experience to Curebase as the newly appointed VP of People.

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Curebase, Portamedic Partner to Support Decentralized Clinical Trials with Mobile Phlebotomy Services

Curebase and Portamedic partner to collect patient samples and other tests from participating DCT trial patients' homes throughout the U.S

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Curebase Hires Healthcare Technology Veteran Scott Garcia as Vice President of Finance

Scott Garcia brings 15+ years of experience scaling high-growth companies to Curebase as the new VP of Finance

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Curebase, Flow Neuroscience Announce Joint Clinical Trial  for the use of an at-home tDCS device for treating depression

Curebase and Flow Neuroscience investigate a digital therapeutic for reducing depressive symptoms.

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Curebase Adds Pharma, Clinical Research Veteran to Advisory Board

Lars-Olof "Lollo" Erkisson, Head of Clinical Development at Infant Therapeutics AB, brings cross-continental clinical operations expertise to Curebase Advisory Board

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Curebase Secures $40M Series B

Curebase closes $40M Series B led by Industry Ventures, with strategic investment by Gilead Sciences

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Curebase Named Honorable Mention in Best World Changing Idea NA Category of Fast Company’s 2022 World Changing Ideas Awards

Curebase recognized by Fast Company's 2022 World Changing Ideas Awards for decentralized, patient-centric trial model

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Note to File Podcast - Episode 45: Jane Myles, Decentralized Clinical Trials: Evidence of Impact

Part 2 of Note to File Podcast with Brad Hightower featuring Jane Myles, VP of Clinical Trial Innovation at Curebase

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Curebase Selected to Launch a Clinical Investigation of a Digital Therapeutic for IPF

Curebase and Vicore Pharma partner on IPF mental health digital therapeutic study

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DCTs’ Broader and Multifaceted Implications

Curebase featured as decentralized clinical provider optimizing digital processes for patient safety and scientific advancement

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Decentralized Clinical Trials Help Level the Playing Field for Health Equity

Jane Myles, VP of Innovation at Curebase, discusses how DCTs play a role in improving health equity

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Note to File Podcast - Episode 41: Jane Myles, VP Innovation at Curebase

Jane Myles appears on Note to File Podcast with Bradley Hightower to discuss all things DCT

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Curebase Rapidly Reaches Growth Milestone

Curebase hires its 100th teammate within six months of raising Series A financing

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Curebase and Blue Note Therapeutics Collaborate on Home-based Clinical Trial of Prescription Digital Therapeutics to Help People with Cancer Manage their Health

Curebase and Blue Note Therapeutics partner on a fully virtual study comparing effectiveness of two PDTs on mental and physical health of cancer patients recently/currently undergoing treatment

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Curebase and CoBTek (team from Côte d'Azur) to Collaborate on a European Clinical Trial of Remote Tools Designed to Help Seniors Retain Autonomy

Curebase launching DCT study in Italy and France with a lab from the University of Côte d'Azur to improve the quality of life for elderly people

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Curebase Adds Two Clinical Trial Veterans to Kick-off New Advisory Board

Curebase welcomes Dr. Amir Lahav, leading digital health innovator, and Dr. Aaron Kamauu, leading real-world data expert, to new Advisory Board

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Curebase Joins the SCRS Global Impact Partner Program

Curebase will work closely with Society for Clinical Research Sites to advance trial site engagement and sustainability

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The Growing Case for Digital Therapeutics

Continuous developments in digital health innovations has led to the expansions of the Digital therapeutics dtx clinical trial space

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Creating New Decentralized Clinical Trial Ecosystem Including Bring Your Own Physician Option with Tom Lemberg Curebase

Tom Lemberg, founder and CEO of Curebase, talks all things BYOP (Bring Your Own Physician) on Empowered Patient Podcast

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2022 Predictions for Health Equity

Healthcare IT Today features predictions from Tom Lemberg, founder and CEO of Curebase, on diversity in clinical research

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The Future of Clinical Trials is Here Today

Curebase founder and CEO, Tom Lemberg, discusses the future of patient-centric decentralized clinical trials, including the Bring Your Own Physician (BYOP) model

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Curebase and Persephone Biosciences Partner in Clinical Trial of Colorectal Cancer Among Diverse Populations

Curebase and Persephone, collaborating with Janssen Research & Development, announce study to develop prevention strategies and treatment options for colorectal cancer (CRC) focusing on patient diversity

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Built In Honors Curebase in Its Esteemed 2022 Best Places to Work Awards

Curebase Earns Top 100 on Built In's Best Remote-First Companies to Work for in 2022

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Curebase Joins WCG Avoca Quality Consortium

Decentralized clinical trial company brings expertise in remote studies to large industry group devoted to improving trial quality

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Curebase Technology Key to metaMe Health's FDA Clearance of Regulora

Curebase serves as technology and decentralized trial execution partner for MetaMe Health's digital therapeutic dtx

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Curebase Named to the 2021 CB Insights Digital Health 150 -- List of Most Innovative Digital Health Startups

Curebase recognized for achievements in Clinical Trials Tech

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Curebase CEO, Tom Lemberg, Featured in Drug Discovery and Development's "9 Predictions for Pharma in 2022"

Curebase CEO offers expert insight into the dawn of dynamic clinical trial designs

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Forbes 30 Under 30 Names Curebase CEO Tom Lemberg to it's 2022 List

Founder and CEO of Curebase receives Forbes 30 Under 30 prestigious honor for leading positive, global change in healthcare

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Curebase's Enhanced Telemedicine Feature Expands Patient Access to Edesa Biotech Derm Study

Edesa Biotech uses Curebase's eClinical platform for enhanced telemedicine that allows providers to view, measure, and record patient symptoms via the built-in application

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Curebase, LEVEL Announce Clinical Trial to Determine Whether Cannabinoids Can Help Veterans Sleep Better

Decentralized clinical trials leverages Curebase eclinical software platform, Veterans' advocacy groups

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Curebase, Checkable Medical Announce Joint Clinical Trial to Assess Effectiveness of At-home Strep Test Kit

Curebase and Checkable Medical launch first-ever at-home strep test decentralized clinical trial

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Curebase, Digital Therapeutics Alliance Announce Partnership to Accelerate Adoption of DTx Products

Curebase and DTA partner to develop a joint white paper to provide clinical trial regulatory guidance and best practices for DTx clinical evidence generation

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Curebase Solutions Supports Another InBios FDA Emergency Use Authorization for COVID-19 IgG Antibody Rapid Test

Curebase's decentralized clinical trial approach helps secure FDA Emergency Use Authorization for InBios' new COVID-19 IgG Antibody Rapid Test

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Curebase Hires Katri Langel as Senior Director of Program Development for Europe

Katri Langel, international IT and clinical research expert, joins Curebase as Senior Director of Program Development for Europe

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Curebase Hires Wayne Bowden as Vice President of Business Development

Curebase names clinical trials veteran, Wayne Bowden, as Vice President of Business Development to lead new growth and expansion efforts

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It's a virtual world: Curebase, AppliedVR team up on virtual reality-based, at-home clinical trials

AppliedVR will test its virtual-reality-based digital therapeutics dtx across five studies using the decentralized clinical trials software from Curebase

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Curebase Secures Jane Myles as Vice President of Clinical Trial Innovation

Curebase has named tenured clinical research expert Jane Myles as vice president of clinical trial innovation

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Curebase, Adaptive Biotechnologies Announce Collaboration to Expand Clinical Study Access

Curebase decentralized clinical trial model will be used to study effectiveness in infections disease study

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Introducing ‘BYOP’ Clinical Trials

Curebase is promoting the concept of 'bring-your-own-physician' clinical trials.

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Curebase Names Paul Donnelly as Senior Vice President of Enterprise Strategy

Industry veteran, Paul Donnelly, brings more than two decades of success building healthcare companies to Curebase

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Startups Cash In as Venture Funding for Digital Health Rises

Curebase featured in Wall Street Journal among startups realizing venture capital boom in digital health

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Curebase, InBios Announce Results of Virtual Clinical Trial of InBios COVID-19 Rapid Detection Test Using Curebase Platform

Curebase decentralized trials platform used to study efficacy of diagnostic test

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Curebase Nabs $15M for Siteless Trials that Revolve 'Around the Patient's Lifestyle'

Curebase has raised a $15 million series A for a new approach to decentralized trials that goes beyond the current drop of virtual trial platforms.

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Cofactor Genomics Begins Multi-Site Clinical Trial for Immunotherapy Prediction Assay

Curebase is participating as a CRO partner with Cofactor Genomics in first multicenter clinical trial of its OncoPrism immunotherapy response prediction assay

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Non-Traditional Clinical Trial Sites Powered by the Curebase System Support Emergency Use Authorization of New Rapid COVID-19 Test

Operationalizing drive-through COVID testing locations as clinical research sites provided a safe and convenient way to enroll and consent potential participants in key diagnostic validation study

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CLM Tests Drug Plus Digital Combo for High Blood Pressure

CLM drug and DTx digital therapeutics study with Curebase

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Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.

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Remote Care Powered CURE-19 Platform Enables At Home COVID-19 Clinical Trials

Curebase launches the CURE-19 Platform to provide a resource for researchers seeking to better understand COVID-19 as the pandemic begins

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