Blockchain saves lives and makes clinical trial fraud impossible

Bitcoin was originally designed to save people’s lives from being destroyed by centralized monetary systems and flawed policies enacted by governments and central banks. When Satoshi Nakamoto published the Bitcoin whitepaper, who could have imagined that it could also save lives?

As developers continue to discover new applications for Bitcoin’s underlying blockchain technology, one of the biggest breakthroughs is its application to the drug development and testing process. Drug development is a costly and time-consuming process. Silicon proteins and drug modularity have significantly reduced the time required to develop new drugs, but it still takes years to get them to market. In order to launch a drug, it must first pass rigorous laboratory mouse and human testing, and only when the relevant regulatory agencies, such as the Food and Drug Administration (FDA), review and pass these tests will the drug be allowed to be sold.

Even if a drug works well in treating a disease, it may cause some serious side effects, leading to other serious health problems or even life-threatening. Clinical trials are conducted not only to monitor the effectiveness of drugs, but also to check for all the side effects that may be harmful to you, and to measure both positive and negative effects. However, drug companies and scientists may only selectively share the positive effects of these drugs and conveniently ignore some side effects. For example, a paroxetine antidepressant drug was reported to be effective in treating depression in patients. However, subsequent studies have shown that this drug is not so effective. Instead, paroxetine was found to increase suicidal behavior. This clinical trial falsification directly threatens the lives of patients. Today, the application of blockchain technology in clinical trial records can completely eradicate the emergence of falsification.

Recording clinical trial protocols on blockchain

To prevent pharmaceutical companies and researchers from falsifying data, Cambridge University researchers and doctor Greg Irving have created a blockchain-based system to record and independently verify that clinical trial protocols follow research regulations. Irving applied the immutability of the Bitcoin blockchain in this proof of concept. Currently, Irving and John Holden jointly published this proof of concept on F1000 Research.

The purpose of the proof of concept that Irwin created was to ensure that drug companies or researchers do not deviate from the actual clinical trial and prevent them from modifying the real trial protocol to meet their desired results. As part of the proof of concept, Irwin used a study protocol entry from the ClinicalTrials.gov website. He created a plain text file that contained predetermined endpoints and planned analyses described by the uploader. Using the Xorbin SHA-256 hash calculator, the data of this document was then converted to SHA-256. The resulting SHA-256 hash was used as a private key for a Strongcoin Bitcoin wallet, which then created a public key to conduct transactions. Another wallet's public key was then generated through a Bitcoin transaction of any size corresponding to the SHA-256 hash as the private key. These transactions record the public key on the blockchain, where verification of transactions is easier.

Now, anyone with this unformatted text containing a clinical trial agreement can follow the same steps to generate a public key that corresponds to the one that was initially generated and verified on the blockchain for transactions of any size. If the two public keys match, then not only can the document exist through the timestamp, but it can also be proven that the document has not been altered. If it has been altered, the SHA-256 hash created will be different from the original, resulting in a different public key.

Owen described the process as efficient because bitcoins that confirm the existence of the text can be retrieved from the wallet while maintaining the integrity of the clinical trial protocol. Although Owen used a manual method to create this proof of concept, it can also be automated and public. Any changes to the protocol can be recorded under a separate entry, and these changes can be verified in a similar way by using a corresponding private and public key.

Greg Irving and John Holden's study is consistent with the Declaration of Helsinki, which requires that all clinical trials be recorded and published in publicly accessible databases, while preventing data manipulation practices such as altering trial results and selective release of trial results that would undermine the integrity of the published content.