The applications of blockchain in clinical trials
Written by Helen Blomfield and Kabil Ghhogra
So far in our posts on blockchain, we’ve given a brief overview on what blockchain is and an introduction to ways it could be used in the supply chain for the pharmaceutical industry. We’ll now be examining some potential use cases for blockchain within clinical trials, focusing on smart contracts, transparency, and audits.
Smart contracts (also called self-executing contracts) are contracts coded into the blockchain. The contracting parties are anonymous (unless determined by both parties) and the contract executes itself when certain trigger points are reached – e.g. exchanging detailed data following anonymous screening of initial basic data.
One potential use of a smart contract is to make anonymized patient data available for clinical trials recruitment. In this example, the initial data could be circulated, run through an automated criteria check, and an automated consent form would then be provided to the (still anonymous) patient. Should they choose to accept, their full data would be shared with the pharmaceutical company, allowing them to be enrolled in the trial. This would provide a way around current data availability restrictions, as well as enabling patients to be more informed about available clinical trial options.
Additionally, as the smart contract would then “travel” with the patient throughout the clinical trial process, it would provide a way of ensuring consent throughout the entire trial, reducing the administrative burden in managing consent forms and access permissions to data. Later in the trial, if a new investigator was introduced, they could request access to data through the smart contract, which could either be automatically enabled (if the new investigator met all defined criteria of the contract) or manually approved and logged within the blockchain.
Smart contracts using blockchain therefore provide a way of increasing patient enrollment efficiency while reducing the administrative burden of managing a patient throughout the clinical trial process.
Following record low ratings in 2016, a 2017 Gallup poll found that only 33% of people rated their opinion of the pharmaceutical industry as “somewhat positive” or “very positive” (only beating the federal government by 4%, and 39% lower than the restaurant industry).
Trust is a significant issue for most pharmaceutical companies and one of the ways to increase public trust in published results is to increase the transparency of clinical trials. Blockchain’s decentralized tracking system, combined with a peer-to-peer network – potentially an industry association, with access granted to key university researchers – can provide a transparent, traceable ledger of transactions that have taken place during a clinical trial.
Using this method allows originator data to be anonymised, while using common identifiers enables tracking of unusual trial results to a single site. Additionally, any data and edits could be traced to point of entry, meaning that the trial protocol could either continue as originally established or change based on verifiable, well-documented reasons. For pharmaceutical companies, this would provide a valuable opportunity to demonstrate the scientific validity and consistency of their clinical trial results, increasing public trust.
Tying directly into the transparency discussion of clinical trials, blockchain can also provide an easy way of reducing the administrative burden of auditing trials.
Blockchain can be used as an unchangeable data trail, showing when and where key information is added, including (but not limited to) protocol compliance checklists, human subject records, informed consent forms, financial disclosure forms, and electronic records. This ensures that data cannot be altered or lost along the process, making it easy to prove full compliance with legal requirements to regulators.
As the data is available within a peer-to-peer network, regulators can be made authorised users or inspectors. This would make spot-checks of data more feasible and reduce the need for lengthy external audit processes. This could also improve relationships between trial centers and regulators, and potentially reduce audit failure rates.
Additionally, by storing all information digitally, pharma companies can use basic automation checks to ensure compliance, both reducing the human time required to manage clinical trials and the potential for errors in a checklist process.
In this post, we covered three applications for blockchain within clinical trials:
- Using smart contracts to more easily enroll patients and reduce the administrative burden of managing consent and data access.
- Enabling transparency of process and clinical trials results, increasing public trust in pharmaceutical companies.
- Reducing the administrative burden of auditing trials.
In our next (and final) blockchain blog post, we’ll be evaluating the technology already in use.