Implementation of a Daml Solution for Optimizing Clinical Trials
Conducting clinical trials is a time consuming and costly process that brings along unique and intrinsic challenges. In a recent blog post, Lakshmi Shastry, Principal Solutions Architect at Brillio, talked about the challenges around the clinical trial process and highlighted the different ways multi-party workflow technology, including key components of Brillio's solution with Daml, can address this industry challenge. In this 2nd blog post of a two-part series, Lakshmi will demonstrate how pharmaceutical companies and other clinical trial participants (i.e. Sponsors, CROs, Regulatory Agencies) can use Daml to collect and store patient/participant data and analyze results in a private yet collaborative manner. The end result is an improved and vastly more automated clinical trials process.
Implementing our solution
Let's consider a sample clinical trial network with following participants:
- Pharmaceutical Company (Sponsor)
- Regulator
- CRO’s
- Hospital
- Patient/Participant
Using Daml, we onboard the various parties onto the network while respecting each party’s consent and data sharing rules.
How does our solution solve the problems?
Improved protocol adherence and violation reporting
Our approach digitizes the protocol through Daml smart contracts based multi-party workflows that improves compliance, better management of protocol deviations, and faster audits.
For instance, smart contracts ensure that unless the patient/participant grants consent (through digital signatures), no data can be entered for the patient/participant. If subsequently the patient/participant withdraws consent, no updates to the patient/participant data can be made unless reauthorized by the patient/participant.
Improved data sharing and regulator collaboration
Regulators can act as a node and have real time access and visibility into the entire clinical trial generation and sharing process. As Regulators maintain their own version of a Distributed Ledger, they do not have to rely on Pharmaceutical Companies or the Healthcare provider for data which improves flexibility and can reduce the compliance requirements for pharmaceutical companies.
Daml has the ability to add parties as signatories or observers to provide data visibility. Please take a look at the below code snippet as an example.
In the above example, the provider and participant have the authority to exercise the choices. However, the CRO and coordinator can see the data but won’t be able to take any action on top of it. It will just provide the data visibility for observers.
Patient centricity
Since Permissioned Blockchains enable secure transfer of data, sets of contracts can be created to improve patient access and centricity. For instance, smart contract rules can be created such that patients will receive immediate ownership of their data at the termination of the Clinical Trial.
In Daml, every participant will record each visit in the ledger. Also, the provider can log the symptoms and doses as part of their visit. Please see the code snippet below:
Summary
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.
In our platform, Daml and Microsoft Azure work together to improve the clinical trial process. Beyond clinical trials, this open solution architecture offers new areas of collaboration and data sharing across health care systems. We can now provide patients ownership of their data, as well as create economic and healthcare incentives for data sharing across participants while automatically enforcing regulatory requirements, thus providing enormous savings and rapid innovation at the same time.
For more information, please download our latest eBook that discusses the challenges and solutions in greater detail.