And this includes Phase I through Phase IV clinical trials. Further, ICMJE (whose guidelines most medical journals follow) also recommend that journal editors require registration prior to publication of any clinical trial. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.īlockchain Clinical Trials Ethereum Missing Data Smart Contract.I think most researchers and publishers of clinical research recognize the value of clinical trial registration.įor those of you unsure what this applies to, broadly WHO describes a clinical trial as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." This means that observational studies - where the investigator does not assign an intervention - does not classify as a clinical trial.īoth the WHO and ICMJE both recommend registering clinical trials in a WHO-approved publicly accessible database. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication.
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