Federated Virtual Clinical Trial Assignment System
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Solution Overview
Problem
Conducting virtual clinical trials poses challenges in maintaining blinding and random assignment of participants to treatment groups while ensuring privacy and adherence to specific assignment ratios, which are crucial for the validity and trustworthiness of clinical trial results.
Innovation Solution
A system utilizing a federated computation server, intervention server, and trusted initializer to implement multi-phase virtual clinical trials with encryption techniques for different levels of blinding, ensuring participants and servers remain unaware of group assignments, and using Beaver triples and random initialization vectors to securely assign participants to intervention or placebo groups.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If encryption techniques and multi-phase protocols are implemented to maintain blinding and privacy, then participant privacy and assignment security are improved, but system complexity and computational overhead increase
Solution Approach 1:
The clinical trial assignment process is divided into multiple distinct phases: setup phase where thresholds are established, assignment phase where participants are randomly assigned to groups using encrypted computations, and verification phase where assignment ratios are validated. Each phase operates with specific cryptographic protocols, segmenting the complex task into manageable, secure stages that maintain blinding throughout.
Solution Approach 2:
A trusted initializer acts as an intermediary that generates Beaver triples (cryptographic primitives) without revealing sensitive information. This mediator enables secure multi-party computation between the assignment system and participants, allowing randomization and blinding to be maintained through cryptographic mediation rather than direct trust relationships.
2Reliability
If federated computation and secure multi-party protocols are used to ensure random assignment and privacy, then assignment security is improved, but computational resources and processing time increase
Solution Approach 1:
Beaver triples and cryptographic parameters are pre-computed and stored during a setup phase before the actual clinical trial assignments begin. This preliminary preparation allows the main assignment process to use these pre-established cryptographic primitives efficiently, reducing real-time computational overhead while maintaining security.
Solution Approach 2:
The system uses adjustable cryptographic parameters and fixed-precision floating-point representations that can be optimized based on security requirements and computational constraints. By carefully selecting precision levels and cryptographic strength, the system balances security assurance with computational efficiency.
Data Source
AI summary
The technology disclosed relates to a system and method for assigning participants to groups in a clinical trial. The system includes a federated server configured with group assignability data specifying a plurality of groups assignable to participants in a clinical trial and group distribution data specifying distribution of the participants into groups. The groups include at least one placebo group and one or more treatment groups. The system includes an intervention server configured to generate group encryption keys for encrypting the group assignability data. The system includes edge devices of each of the participants. The edge devices are in communication with the federated server.