Blockchain’s potential to improve clinical trials—an essay by Leeza Osipenko

What are blockchains and smart contracts?

Blockchain is a way of managing data that prevents their manipulation.1 A new “block” of data records each specific event. Each block is time stamped and includes cryptographic information (a “hash”) from the previous block. These hashes link blocks securely to form chains, making data modification impossible without changing the entire chain.

All users in a network have their own copy of the blockchain. This decentralisation of data enables transparency and further security, because any modification has to be sanctioned by all users.1 Current, centralised ways of managing data lack such assurance.

Blockchain cannot protect from errors when data are entered, but it can ensure the provenance of data and improve transparency. Erasing blockchain data is impossible, so data can be updated or modified only by adding new blocks, and any obsolete blocks will remain.

Smart contracts are versatile computer algorithms mandating that all users follow prespecified rules for a given task,1 without the need for centralised supervision or inspection. For example, smart contracts could replace many activities in auditing clinical trials. Currently, auditors ensure that specific documents are in order before an investigator can begin a trial. A smart contract could be coded to mandate that patient enrolment cannot begin before all documents are uploaded.

Blockchain’s underlying technical features make no difference to users, who interact with a conventional web based interface for entering and retrieving data.