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Improving data transparency in clinical trials using blockchain smart contracts
Timothy Nugent1, David Upton2, Mihai Cimpoesu2
1Corporate Research and Development, Thomson Reuters, London, UK.
Abstract:
The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.
Insights
Blockchain smart contracts can enhance clinical trial integrity by preventing data manipulation. This technology acts as a trusted administrator, ensuring an immutable record of trial history and boosting scientific credibility.
Area of Science:
- Biomedical research
- Computer science
- Blockchain technology
Background:
- Clinical trial credibility is compromised by issues like missing data, endpoint switching, and selective publication, leading to distorted treatment perceptions.
- Existing legislative interventions have had limited success in addressing these integrity issues.
Purpose of the Study:
- To extend the use of blockchain technology in clinical trials.
- To demonstrate how smart contracts can enforce trust and eliminate data manipulation in clinical research.
Main Methods:
- Utilized blockchain smart contracts, which are self-executing code and data on a blockchain.
- Employed cryptographic validation by the network to ensure the integrity of contract execution.
- Established an immutable record of clinical trial history.
Main Results:
- Demonstrated that blockchain smart contracts can serve as trusted administrators for clinical trials.
- Showcased the elimination of data manipulation through the immutable record provided by smart contracts.
- Validated the effectiveness of this technological solution in enforcing trust.
Conclusions:
- Blockchain smart contracts offer a novel technological solution to combat data manipulation in clinical trials.
- Implementation of smart contracts can significantly enhance the trustworthiness and reliability of clinical trial findings.
- This approach provides an immutable and cryptographically secured record, bolstering scientific credibility.