Decentralized Clinical Trial Data Access via Patient Portal Obfuscation
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Solution Overview
Problem
Existing technologies for online ordering and fulfillment in clinical trials fail to accommodate the unique workflows and data access controls required by clinical trials, particularly due to anonymity and blinding regulations that restrict access to patient identifying information.
Innovation Solution
The implementation of a decentralized clinical trial system that uses a patient portal system to manage supply kits, patient data, and sample pickup, while ensuring proper access and separation of data through obfuscation and encryption techniques, allowing clinical trial providers and participants to manage data in compliance with anonymity requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If data is made accessible to patients for visibility into shipment status, then patient compliance is improved, but patient anonymity is compromised
Solution Approach 1:
The patent segments patient data into two distinct types: identifying information (name, address, contact details) and non-identifying information (shipment status, trial progress). The system allows patients to access only non-identifying information through the patient portal while maintaining anonymity. This segmentation enables compliance improvement without compromising anonymity by restricting access to identifying data while providing visibility to trial-related status information.
Solution Approach 2:
The patent introduces an intermediary system - the patient portal platform - that acts as a mediator between patients and the clinical trial database. This intermediary provides a controlled interface where patients can view shipment status and trial information without direct access to identifying patient data stored in the clinical trial database. The intermediary enables information access while maintaining data separation and anonymity requirements.
2Productivity
If clinical trial providers access patient identifying information for supply kit management, then operational efficiency is improved, but regulatory compliance is worsened
Solution Approach 1:
The patent segments data access rights by function: supply chain and logistics systems access identifying information (name, address, contact) for operational purposes, while patient-facing systems access only non-identifying information. This segmentation enables operational efficiency in supply kit management while maintaining regulatory compliance through strict data access controls and separation of functional systems.
Solution Approach 2:
The patent applies local quality by providing different data access characteristics to different systems and users. Systems requiring operational efficiency (supply chain, logistics) receive identifying data locally, while patient-facing interfaces receive only anonymized data. This localized data availability optimizes each system's performance while overall compliance is maintained through centralized data governance.
3Reliability
If data is separated to maintain anonymity, then regulatory compliance is improved, but system complexity is worsened
Solution Approach 1:
The patent implements a universal patient portal platform that serves multiple functions: providing patient education materials, tracking shipment status, communicating with trial sites, and accessing trial progress - all while maintaining data separation. This multi-functional approach consolidates complexity into a single unified system rather than requiring separate systems for each function, thereby improving compliance while managing system complexity.
Solution Approach 2:
The patent creates a simplified copy or representation of patient data for the patient portal that contains only non-identifying information. This data copy allows the patient-facing system to function without accessing the full identifying data stored in the clinical trial database. The copying approach enables regulatory compliance through data separation while managing complexity by providing a straightforward data structure for patient access.
4Object-affected harmful factors
If manual contact methods are used for shipment status, then data access controls are maintained, but patient compliance is worsened
Solution Approach 1:
The patent enables self-service by allowing patients to independently access shipment status and trial information through the patient portal without requiring manual contact with trial sites or investigators. Patients can view their own data, track supplies, and communicate with the trial system autonomously. This self-service approach maintains data access controls by letting patients view only their own non-identifying information while significantly improving compliance through increased engagement and accessibility.
Data Source
AI summary
Disclosed herein is a system and method for controlling data access within a decentralized clinical trial space. In various embodiments of the present invention, a patient portal system may be interconnected with a clinical trial database, a patient device configured to access a patient portal application associated with the patient portal system, and an intermediary system having an intermediary database. Data transmitted from the patient device to the patient portal system may comprise obfuscated patient data. Such obfuscated patient data may be transmitted to the intermediary database which may be configured to access the identifying patient data from the obfuscated patient data through a private key stored therein. The patient portal system may enable a patient to perform a variety of functions relating to a clinical trial, such as ordering a sample collection kit, to be fulfilled by a supply system interconnected with the intermediary database.