Conducting clinical trials is a time consuming, expensive affair that involves close collaboration between multiple stakeholders (parties), often geographically distributed, and one that needs a high level of monitoring, regulation, and precision to maintain patient privacy and auditability. In this two-part blog series, Lakshmi Shastry, Principal Solutions Architect at Brillio, explains the challenges around clinical trials and how emerging multi-party workflow technology can be leveraged to improve the clinical trial process.

Challenges of conducting clinical trials

The multi-party and distributed nature of the clinical trials process brings along unique, intrinsic challenges such as:

• Multiple participating entities and workflows having disparate databases that must be constantly reconciled
• Privacy and confidentiality considerations for each stakeholder and individual participant
• Complex data collection, protection, sharing and reporting requirements across enterprise boundaries
• Patient engagement over long periods of time
• Data domicile and compliance needs
• Multiple entities using different technologies for critical processing
• Manual work that increases risk for data accuracy

Using emerging multi-party workflow technology such as Daml, we can solve some of the problems described above. We will talk about Brillio's Blockchain-based Clinical Trial solution in the subsequent section and how it can be put in action.

Current implementation of the clinical trial process

Nowadays, different steps of clinical trials are conducted independently of each other. This is partly because of legacy technology and legacy approaches to conducting clinical trials, and partly because of no better alternatives.

The current process entails the following:

• Data gets created for multiple patients/participants from multiple networks – hospitals, clinical trials, smart devices. 
• Data is then collected and entered into a Centralized Database Management System (DBMS) separately for each organization. 
• Different pharmaceutical companies, hospitals, CROs, Biotech, laboratories have their own decentralized databases. Different organizations then collate and store data in their own preferred way and own preferred format in their own IT environments. 
• Data is then analysed separately within each organization and exchanged in different forms between various organizations for regulatory reporting, business analytics, research and other purposes.

In this model, not only collaboration is difficult between participating organizations, it also complicates communication internally, resulting in more reconciliation and more human error.  Additionally, effort expended to solve data consistency issues is large. The proverbial wheel is reinvented for each trial.

Brillio's solution

Brillio’s solution is a permissioned multi-party network in which:

• Various Stakeholders such as pharma companies (Sponsors), CROs, Regulators (FDA, EMA, etc.), Clinics, and Patients participate within a networ
• Data sharing and clinical trial execution takes place in a distributed and secure manner with custom Daml workflows based on the Clinical Trial Protocol
• All Stakeholders maintain their own local, private version of the data which is automatically synced under the hood by Daml based on workflows and privacy rules agreed between parties (i.e. no more reconciliation or checks and balances)
• Each party remains in sync in real time with the latest state of the clinical trials business process, seeing only the data they are supposed to see. This avoids costly privacy gaps because no tack-on authorization models are needed. Azure cloud is leveraged to provide high performance and scalability. However, the solution can meet each participant’s cloud preferences if needed.

Key parts of Brillio's solution

Parties

Parties refer to the Pharmaceutical companies (Sponsors), Regulator, CRO's, and Hospital that participate in the network. For instance, each Pharmaceutical company is a party. Similarly, each Hospital and each regulator (i.e. FDA, EMA) is a party.

Network

Networks represent the multiple organizations, different identities, and associated data visibility rules. Data is shared only within a network between the participants.

Transaction History

Transaction History is the historical log of all the transactions on the network. Since the underlying ledgers are append only, all the transactions can be replayed to arrive at the current state. Each participant in the network stores their own version of the Ledger which is automatically synced as required based on the privacy and data sharing rules. Transaction History is available to view for all allowed participants in the network in real time.

Smart Contracts

Smart contracts or multi-party workflows of Daml change and control the state of the ledger within the network. These rules also automatically enforce authorization as well as physical domicile of the data thus simplifying compliance.

Brillio uses Microsoft Azure that offers frameworks and tools to simplify development of this network on cloud.  From integration to monitoring, network configurations, multi-party workflow development, privacy and distributed computing capabilities, Microsoft Azure powers a data-driven approach in clinical trials.  

Brillio’s  three step approach using Microsoft Azure and Daml is to:

1. Build a multi-party network using a rights and obligations model

2. Simplify governance and management respecting each party’s technology choices

3. Integrate solution with existing systems and tools to reduce IT roadmap complexity

Daml is an open-source runtime designed specifically for building distributed, multi-party workflows, allowing applications to work across multiple underlying data storage platforms (databases or blockchains) with interoperability between different networks.  Daml integrations, APIs, and run-time features are built-in safeguards that protect data integrity and privacy, and create an interoperable system in which multiple parties, including Pharmaceutical companies (Sponsors), Regulators, CRO's and Hospitals can connect to with absolute trust in their Clinical Trial Process. Daml thus provides significant benefits beyond traditional technology, positioning users as the provider of choice with the given market.

Microsoft Azure serves as the foundation to manage these networks for digitized workflows shared across clinical trial stakeholders.   

We believe such a solution that preserves privacy while allowing for seamless collaboration has the ability to transform  clinical data collection, data sharing, and operations. Clinical Trial Processes based on blockchain technology can streamline data transfer, ensure real time data access across clinical trial participants, reduce data entry errors, and simplify the clinical trial audit and compliance process.