Technology and Data Harmonization for Enabling Decentralized Clinical Trials

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.

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

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

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

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

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

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

• Test and evaluate various new technologies throughout a clinical trial value chain.
• Collaborate with peers bringing your expertise to develop consensus-driven solutions in an impartial scientific environment.
• Ownership and access to a proven workflow with no economic risk(s).

• Expose proprietary technology solutions to a broader market and potential users.
• Test or prove your technology with program participants.
• Drive adoption of new technologies by developing certified technical standards.
• Recognition for developing a workflow.

• Ensure your interest area is considered and reflected in the development of workflows.
• Advocate new workflows and standards that facilitate inclusion and more efficient clinical trials.

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.

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).

To learn more about the program and how to join the Technology and Data Harmonization for Enabling Clinical Decentralized Clinical Trials activity, please express your interest by sending an inquiry to the activity chair whose information can be found in the Contacts section.