Digital Technologies for Compassionate Use and Managed Access Programs
Posted on 06/24/2022

On June 8-10th, 2022,  Early Access Care participated in the Annual eClinical Forum Spring workshop in Ringoes, New Jersey.   The eClinical Forum is a global group of industry peers, comprised of Pharma companies, CROs, Clinical Trial Sites, Academia, Technology Providers, and Regulatory Professionals, with over 1900 members from 56 companies spanning 36 countries and 7 business areas.   Early Access Care joined the eClinical Forum in order to share its expertise, exhange information, and focus on data excellence in technologies and processes. 

The topics discussed during the Spring 2022 meeting included:

·         FDA Guidance’s on Real World Evidence and Digital Health Technologies

·         Trial Tokenization

·         The value of passive data collection through wearables

·         Direct Data Exchange with EHR

·         Risk Based Cleaning

·         Data Standards for Digital Measures

·         Decentralized Clinical trials (Incorporation of DCTs, Site Perspectives, Bring Your Own Investigator (BYOI), Informed Consent Process)

·         eISF

·         Artificial Intelligence and Machine Learning

There were two topics that were directly relevant to Expanded Access Programs.  The first being Risk Based Cleaning. When executing a clinical trial or expanded access program, data cleaning is performed to clarify, correct or locate missing data or data that is out of range.  In the past every variable was cleaned and queried.  By incorporating a Risk Based Cleaning Strategy into a clinical trial or program, critical data points are identified and categorized (e.g. Critical Datapoints, Supportive Datapoints, Minimal Datapoints or A (Important), B (somewhat important), C (not important)).  Defining a Risk Based Cleaning Strategy will allow one to detect the risks and act on them when appropriate leading to a more efficient data cleaning and querying process.

The second being the use of supporting digital technologies.  Over the past decade, there has been a global increase in the use of smart phones and wearables such as FitBits and Apple Watches. Also, online visits with medical providers and e-portals such as MyChart have become common place.  Due to COVID restrictions, there was an increase in the use of digital technologies in Clinical Trials by incorporating telemedicine (video) visits, Direct to patient shipping of investigational drugs, and data collection via smart devices.  There are many applications available that continuously and effortlessly capture data to aid in daily tasks such as navigation and shopping. The Clinical Trial industry is harnessing this technology by creating applications that accurately capture clinical trial data such as ePROs and Daily Diaries.  Our ever-present mobile devices can also capture health data such as how many steps we took, how many hours we slept and some even capture pulse rate and ECGs.  These Apps will help move clinical trials to a more decentralized model.  A decentralized model yields greater diversity, participation, and retention.  With Expanded Access programs, the same technologies are available and can benefit Expanded Access / Compassionate Use Programs as it has for clinical trials. Depending on the needs of the Expanded Access Program, we can leverage the capabilities of a ‘smart’ phone to capture more data and optimize data collection.  We can also incorporate the use of wearables to collect additional Real-World Data.  By reimagining Expanded Access Programs in the future, we will bring more benefits to the patients and to the sponsors.

 

By attending this forum, Early Access Care, LLC is keeping abreast of the ‘hot topics’ impacting the industry.   Our company stays up to date on industry best practices and updates to regulations affecting topics such as eConsent, eCOAs, EDC, etc.

Early Access Care, LLC’s membership in the eClinical Forum allows us to better help sponsors and investigators.  We can assist your companies and sites in navigating the digital landscape and incorporating it into an Expanded Access Program.