Key Insights from the FDA's DHT Guidance
On December 23, 2023, the FDA released guidance for the industry on how digital health technologies (DHTs) should be used in clinical trials.
DHTs, which the FDA defined in their “Framework for the Use of DHTs in Clinical Trials,” are “technologies such as wearable, implantable, ingestible, and environmental sensors and software applications on mobile phones, among others.”
DHTs can be used to collect data from clinical trial participants more efficiently and objectively than traditional methods. For example, DHTs can collect data on participants' activity levels, sleep patterns, and medication adherence. This data can be collected electronically, which can reduce the burden on participants and improve the accuracy of the data
Trends, insights, and news from SCOPE 2024
With over 3,300 attendees across 850 companies, the 16th annual Summit for Clinical Operations Executives (SCOPE) was a huge success. As previous years have shown, what’s big at SCOPE tends to be big for our industry. Thus, we’re summarizing some key takeaways from this year’s conference to understand where the industry may be headed next.
Defining “evidence generation” within modern clinical trials
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.
Taking eCOA technology deployment off the critical path
Within the context of clinical trials, the "critical path" refers to the sequence of activities, tasks, or events that, if delayed or extended, would directly impact the overall timeline for the trial.
These essential steps and dependencies must be completed in a specific order to ensure the trial stays on schedule. Any delay in the critical path can potentially lead to a delay in the entire trial, affecting its completion date and potentially increasing costs. Identifying and managing the critical path is crucial for efficient trial management and timely delivery of treatments to patients.
For a simpler example, take a look at how Monday.com describes the critical path within the context of building a house and their visual aid in Exhibit 2. “For example, if you’re building a house, the critical path might include digging the foundations, building the walls, and installing the roof. If any of these critical activities fall behind schedule the whole project gets delayed.”
J.P.M. Week 2024
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.
You asked we answered: How do eCOAs improve data compliance?
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.
Rapid evolution: How DCT’s DNA became standard in modern clinical trials
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.
Unlocking scalability in pharma with AI
What is the path to addressing the remaining 10,000 human diseases?
Almost two years ago, Medable CEO Michelle Longmire asked this question in a blog titled “Accelerating the path from possibility to proof in the development of new medicines.” Back then, she wrote that leveraging the most meaningful tools we had at the time would drive new synergies at the intersection of safety, science, and speed and enable a new era of drug development.
Today, our industry stands at the precipice of a new era in clinical research, marked by rapid advancements in technologies that society widely refers to as artificial intelligence and machine learning (AI and ML). While each of these technologies has existed for some time, recent advancements in their capabilities have brought them to the forefront of our industry.
In the future, AI and ML may prove to be the most important technologies of our time, as they have the potential to enable true scalability in pharma, as well as other business sectors.
Patient perspectives: The balancing act of trial participation
When we think about clinical trials, our minds often gravitate toward the scientific intricacies of these studies - the testing of new treatments, data analysis, and the quest for medical breakthroughs. However, it's essential to remember that behind every clinical trial, there's a patient, and often a caregiver, whose life is deeply impacted by this journey.
So, let’s consider this: the concept of "Participation-Life Balance" and how technology can enhance the design and workflow of clinical trials while acknowledging the holistic needs of patients and caregivers to work towards achieving this.
You asked, we answered: Is electronic ICF revision easier than paper?
One of the most common questions we’re asked about digital informed consent/eConsent is: What does the ICF amendment or revision process look like within a digital platform and is this harder or easier than traditional paper based approaches?
You asked, we answered: How to Create Your own Multimedia Library for Informed Consent
An often quoted analogy for recruitment into clinical trials is that of the ‘leaky pipe’. In this analogy potential participants drop out of the recruitment funnel at every stage in the process from identification, pre-screening, consenting, screening, randomisation and trial completion.
Research in 2020  showed that of 100 participants identified for pre-screening, only 8 will be randomized, and only 7 will complete the trial. Given that a recent review with the Medable Patient Champion Network (PCN) highlighted that the paper consent process was often considered as ‘intimidating’, the fact that up to 80%  of potential participants are lost during the consent process is not surprising. Metrics such as these highlight the importance of being able to provide a potential participant with the details of a clinical trial in a manner that both engages and educates them. This helps ensure that their very first experience with the trial, and at times the research facility, sets the tone for a positive trial experience.
Once enrolled into a clinical trial, the process of educating a participant and ensuring the consent form is understood, has a direct impact on their retention. Research from CISCRP  showed that 35% of participants that dropped out early from a clinical trial found the consent form difficult to understand, compared to only 16% of participants that completed their clinical trial.
Medable Petitions Comments on ICHE6(R3) Draft Guidance
When technology enters a regulated environment, early adopters often cite regulatory uncertainty as a hurdle. In fact, a 2021 Clinical Trials Transformation Initiative (CTTI) survey showed that regulatory uncertainty and lack of harmonization were the top reasons that hindered adoption of elements of decentralized clinical trials (DCTs).
During the COVID-19 pandemic, the increased adoption of decentralized methodologies was guided by temporary guidances put out by many regulators such as FDA’s March 2020 “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” and the corresponding EMA guidance, which explicitly mentioned it would expire at the end of the designated Public Health Emergency.