Early Access Programs as a Source of Real World Data

Posted on 12/14/2022

Early Access Care, LLC’s membership in the eClinical Forum allows us to gain valuable insight from global participants on hot topics in the pharmaceutical industry. The Annual eClinical Forum Fall workshop was held in North Wales, Pennsylvania on November 14-16, 2022.  The eClinical Forum is a global group of industry peers, comprised of pharmaceutical companies, CROs, Clinical Trial Sites, Academia, Technology Providers, and Regulatory Professionals, with over 2700 members from 64 companies spanning 53 countries and 12 business areas.   Early Access Care joined the eClinical Forum to share its expertise, exchange information, and focus on data excellence in technologies and processes.


The topics discussed during the Fall 2022 meeting included:

·         Audit trails

·         Archiving and Decommissioning

·         Computer Software Assurance

·         Digital Workflow

·         Real World Data/Real World Evidence

·         Decentralized Clinical Trials

·         Use Cases

·         Building a Foundation for digital and Decentralized Clinical Trials

·        Artificial Intelligence and Machine Learning


Globally, pharmaceutical and biotechnology companies are rethinking data collection in the digital health era by incorporating Decentralized Clinical Trial elements into their clinical trials.  Decentralized Clinical Trials are trials conducted using digital technologies with the participant located outside of an investigational site for either some or all of the required assessments.  Digital technologies which may be incorporated include eConsent, Direct to Patient Shipping of investigational medicine and or study supplies, mobile nursing, telemedicine platforms, sensors or wearables, digital recruitment and ePROs.  By leveraging the incorporation of digital technology, it can offer more flexibility for the patient enhancing the patient experience (less travel/disruption in their daily life) and improve participant access and patient engagement.  At Early Access Care, we have been using Direct to Patient shipping and ePROs in Expanded Access Programs.  


The digital transformation of healthcare data presents an opportunity to improve clinical trials by using Real-World Data (RWD).  Real World Data is defined as all healthcare data related to patient health. This includes any data from electronic health records (EHR), billing claims, disease registries, consumer wearables, and remote diagnostic or monitoring equipment.  Real World Data could include measurements from a smart device (e.g., a Fitbit capturing data such as physical activity, sleep, heart rate, oxygen saturation, ECG) or it could come from subjective reports such as Questionnaires on demand such as the EQ-5D-5L, SF_36, etc.  Companies are evaluating how to apply artificial intelligence in capturing the Real World Data.  Expanded Access programs are increasingly used to collect real world data. 


Early Access Care can assist your company in navigating the digital landscape (Decentralized Clinical Trial Elements and Real World Data) and incorporating it into an Expanded Access Program.