Ensuring protocol compliance and data transparency in clinical trials using Blockchain smart contracts

Abstract

Background: Clinical Trials (CTs) help in testing and validating the safety and efficacy of newly discovered drugs on specific patient population cohorts. However, these trials usually experience many challenges, such as extensive time frames, high financial cost, regulatory and administrative barriers, and insufficient workforce. In addition, CTs face several data management challenges pertaining to protocol compliance, patient enrollment, transparency, traceability, data integrity, and selective reporting. Blockchain can potentially address such challenges because of its intrinsic features and properties. Although existing literature broadly discusses the applicability of blockchain-based solutions for CTs, only a few studies present their working proof-of-concept.

Methods: We propose a blockchain-based framework for CT data management, using Ethereum smart contracts, which employs IPFS as the file storage system to automate processes and information exchange among CT stakeholders. CT documents stored in the IPFS are difficult to tamper with as they are given unique cryptographic hashes. We present algorithms that capture various stages of CT data management. We develop the Ethereum smart contract using Remix IDE that is validated under different scenarios.

Results: The proposed framework results are advantageous to all stakeholders ensuring transparency, data integrity, and protocol compliance. Although the proposed solution is tested on the Ethereum blockchain platform, it can be deployed in private blockchain networks using their native smart contract technologies. We make our smart contract code publicly available on Github.

Conclusions: We conclude that the proposed framework can be highly effective in ensuring that the trial abides by the protocol and the functions are executed only by the stakeholders who are given permission. It also assures data integrity and promotes transparency and traceability of information among stakeholders.

Keywords: Blockchain; Clinical trials; Ethereum; Healthcare; IPFS; Smart contracts.

Fig. 1

An overview of a CT process using smart contract and IPFS

Fig. 2

Process flow of the proposed system

Fig. 3

Entity-relationship between different stakeholders and smart contracts

Fig. 4

Sequential illustration of function calls and events in a blockchain-based CT data management system

Fig. 5

CT work process flow

Fig. 6

Testing modifiers wherein (a) function executed with no error as a trial sponsor was the assigned actor while in (b) error appears when an intended actor is not the FDA

Fig. 7

An event is triggered when the FDA makes a decision on the new drug application request

Fig. 8

CT initiation stage cannot occur without the approval of the IND stage shown in (a) while in (b) its successful

Fig. 9

Enrollment of a new patient triggers an event that notifies all members that a new EA is registered

Fig. 10

Event is triggered when the enrollment stage is completed wherein (a) it is not successful as the minimum number of patients is not met unlike in (b)

Fig. 11

Retrieving the CT monitoring details of Patient B

Fig. 12

Event is triggered when an existing patient drops out of the CT

Fig. 13

Retrieving (a) Patient A details after drop out (b) updated list of patient EAs

Fig. 14

An event shows that a patient can no longer be monitored

Fig. 15

An event shows that the IRB rejected SAE report

Fig. 16

An event that shows the CT has been approved by FDA