eCOA

Modern clinical trials employ various digital-based tools and technologies designed to increase the speed, accuracy, and ease of conducting clinical trials. In the best-case scenario, these tools are housed in the same experience or a  “clinical trial platform.” 

Clinical trial platforms are software-based, web-based, and/or cloud-based solutions that facilitate clinical trial research throughout its entire lifecycle. They offer a complete technology ecosystem that connects patients, research sites, and trial sponsors from patient recruitment to close out and data submission. Users of clinical trial platforms can access and operationalize all of their digital-based tools through this connected platform. Platforms can prevent users from accessing parts of the platform not permitted for them. For instance, participants can not view other participants' data or gain access to tools meant for sites. Other users, like sponsors’ study teams, have access to the full suite of tools as needed based on their roles.

Medable has always been, at its core, a platform that enables clinical trial sponsors to collect data and generate evidence to answer scientific questions. 

But from the start, Medable has done things differently. Today, the flexibility, purpose, and build of Medable’s evidence-collection platform is what sets us apart from others in our space.

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‍Over 8,000 participants from all corners of the globe descended on San Francisco this week to attend J.P. Morgan's 42nd Healthcare Conference, taking place at the Westin St. Francis hotel,.

With JPM known for its ability to offer previews of the year ahead, we took the time to summarize the news, trends, and highlights that made waves during this year’s conference. 

We at Medable are often asked in webinars, requests for proposals (RFPs), tradeshows, etc. just how exactly eCOAs and ePROs foster better patient compliance with submitting data. 

Since you asked, our answer is below, courtesy of Jessica Dolfi, VP of Solution Consulting. 

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It’s impossible to deny how different clinical trials look almost four years after the pandemic revolutionized clinical research. Today, the digital and decentralized tools and technologies that enabled clinical trials to carry on through the COVID-19 pandemic are present (in some form) in nearly all clinical trials, a far cry from the dynamics of 2019.

Over the last decade the number of oncology trials has skyrocketed, almost doubling the number of all other therapeutic areas combined, according to the WIRB-Copernicus Group¹. Known for their complex design, oncology trials often present various participant, site, and sponsor hurdles.

Sponsors and CROs looking to tackle these challenges andreduce the burden on participants and sites should explore the potential of digital solutions, particularly electronic informed consent (eConsent) and electronic patient reported outcomes (ePRO). Both tools offer expanded views of the participant journey while offering feedback that enables sponsors and CROs to enhance and refine their trials for all stakeholders.

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According to Grandview Research, the hybrid and decentralized clinical trial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient-centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct. Sponsors are increasingly turning to DCT platforms in alignment with the rise of Life Science and Software-as-a-Service (SaaS) solutions. For those who haven't made the jump yet, there are many questions, including "What is a decentralized clinical trial?" Find out with this in-depth guide to decentralized clinical trials. Uncover how they work, their benefits, and how they transform clinical development.

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At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”.  Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”.  Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).

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In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary. 

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