OBJECTIVES

: Blockchain technology (BCT), the application underpinning cryptocurrencies such as Bitcoin, permit data transfer and management without the need for a third party. The cryptographic properties of blockchains allow for data security and integrity, anonymity, and transactional efficiency. To explore how the use of this technology might help improve clinical trial evidence generation, we critically appraised the literature on applications of BCT in clinical trial design.

METHODS

: Systematic searches were undertaken in EMBASE and PubMed to identify English-language-only studies published from database inception to May 2018 reporting on uses of BCT in clinical trials. Studies on real-world clinical practice or non-healthcare related fields were excluded.

RESULTS

: CONCLUSIONS

: The implementation in BCT-based smart contracts in clinical trial design can be used to generate immutable healthcare evidence that is easily verifiable, and therefore readily assessed for validity and reliability. Future work is required to determine the robustness of applying this technology to trial participant recruitment, control of medical data, and reproducibility of clinical investigations.