Technology and Data Harmonization for Enabling Decentralized Clinical Trials

ENSURING THE EFFICIENCY OF DECENTRALIZED CLINICAL TRIALS

PROGRAM LEADERSHIP

Chair: Walter De Brouwer, Founder, Doc.ai
Industry Advisor: Craig Lipset, Founder and Advisor, Clinical Innovation Partners
Industry Advisor: Isaac R. Rodriguez-Chavez, Ph.D., M.H.Sc., M.Sc., Officer, Clinical Research Methodology, Regulatory Compliance and Medical Policy Development, FDA

OVERVIEW

The speed of research findings can be improved by considering decentralized clinical trials that combine elements of efficiency and implementation for research into routine adoption. The IEEE SA is the world’s largest technological association and can help healthcare researchers and clinicians advance technology for humanity by certifying new industry standards presenting a new frontier in clinical trials.

Join passionate multidisciplinary stakeholders from industry, federal government, academia and non-profit organizations to actively participate in influencing the clinical research field with the adoption of Decentralized Clinical Trials (DCTs) using Digital Health Technologies (DHTs).  The goal is to make DCTs using DHTs more efficient and accessible to trial participants by making it easier for organizations to fully adopt appropriate DCT designs and approaches.
 

WHAT PROGRAM PARTICIPANTS ENGAGE IN?

1. Prioritize the areas DCT using DHT standards can accelerate adoption, mitigate risks, and optimize efficiencies with sponsors, regulators, sites, technologists, service providers, patient advocacy organizations, and other relevant stakeholders
2. Define the standards to build, calibrate, verify, and qualify DHTs and technologies to be used to measure clinical endpoints in DCTs using DHTs to optimize clinical data quality and integrity
3. Build a library of standards and technical recommendations that represent a tool kit for DCT using DHT research methods and approaches
4. Determine the best practices and processes aimed at assisting in the protection of trial participant’s safety and privacy while using relevant data security practices to ensure data quality, integrity and flow
5. Develop best practices to use DHTs and technology-related endpoints, including the use of biomarkers as surrogate endpoints to support DCTs
    

CURRENT WORKSTREAMS IN PROGRESS:

Protocol Development

• Protocol Development for DCTs using DHTs
• Institutional Review Board (IRB) Approval
• Fit for Purpose Devices to Enable Decentralized Study Design

Recruitment

• Digital Patient Recruitment and Retention using technologies
• Training, Adoption and Support for Patients, Investigator Sites and Personnel
• Patient Informed Consent

Shipping and Logistics of Clinical Trial Kits

• Shipment provenance, tracking and auditing
• Shipping of Investigational drugs, devices and trial participant Toolkits

Gathering and Validating Data

• EHRs, Interoperability and data exchange
• Synthetic controls and digital twin simulation
• Verification and validation of patient identity and data privacy
   

WHAT MAKES THIS DIFFERENT WITH THE IEEE SA?

IEEE SA is a prominent global non-profit organization positioned to:

1. Take initiatives beyond best practice recommendations to certified technical standards that can be trusted and adopted by industry entities throughout the globe
2. Provide a maturation platform driving innovation with open source standards
3. Provide a platform for open collaboration for multi-disciplinary stakeholders to build consensus and develop solutions will address harmonization, interoperability of DHTs and technology applications enabling DCTs