Saturday, November 28, 2020

Blockchain to improve clinical trial integrity

 

The year 2020 will certainly be unforgettable for our lifetime. When someone mentions 2020, we will look back and vividly remember the food and essentials shortages, people becoming infected in record numbers, and other interesting events. One area of particular attention has been on the vaccine. We will remember the mad dash to get the vaccine created, approved by the FDA, and distributed. The critical step within this flowchart is to have the proposed vaccine run through the double-blind trials to compare its success rate with placebo. With this race to the cure, there may be pressure placed on the company and researchers to use a statistical grey area to make the data appear in a better light than the actual data. To lessen the opportunity for this to occur, blockchain may be used. For this use case, the clinical trial data would be entered as it is retrieved. As each block of data is entered into the chain, it becomes part of history and can’t be changed, which is a clear benefit of blockchain. After the clinical trial data has been recorded it can’t be changed or updated to improve the results, unless there is a rather extensive attack perpetrated successfully. When the results are close to being approved and the vaccine only needs a few more positive results, the undue pressure to adjust a few results for approval and millions of dollars in revenue may be present. With a fully functioning blockchain in place, this is not an option and improved integrity.



Blockchain is a decentralized digital ledger consisting of records called blocks that is used to record transactions across many computers so that any involved block cannot be changed retroactively, without the alteration of subsequent blocks. This is especially beneficial for logs which cannot or should not be altered or to add a layer of cybersecurity.  

 

Please contact us when we may be of assistance with showing you when and how to apply blockchain to your business and processes.

Charles Parker, II; Principal Scientist; MBA/MSA/JD/LLM/PhD/DCS (IP)

charlesparkerii@gmail.com

810-701-5511


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