Introduction

Two doctors have implemented blockchain technology into clinical trials in an effort to increase the trustworthiness of clinical trial results. Greg Irving along with John Holden have incorporated blockchain technology into clinical trials with the intention of addressing major concerns which plague clinical trials including outcome switching, data dredging, and selective publication. Drug companies and researchers are often faced with high incentives to fudge trial data and manipulate protocols in order to yield the desired clinical trial results.

Enforcement of existing standards is difficult. Despite international regulations requiring trial protocols to be disclosed prior to the commencement of the trials, researchers are still able to manipulate results and change trial protocols to yield desired outcomes. Enforcement is difficult because detection of these fraudulent changes is costly and challenging to uncover when researchers control the clinical trial databases and protocols.

Using blockchain technology, Irving and Holden have shifted the clinical trial data to a distributed ledger open to the public. This reduces chances of fraud, error, and costs. This shift to blockchain technology adds a third party who can audit and validate outcomes. Essentially Irving and Holden have created a “bitcoin notary service” for clinical trials. This new method represents a much more transparent and reliable platform for verifying clinical trial data.

How it Works

The system pioneered by Irving and Holden relies on existing blockchain technology. Under the system designed by Irving and Holden, the clinical trial protocol is given a unique digital signature and recorded on the blockchain, resulting in a unique bitcoin key for the clinical trial protocol. To verify that the clinical trial protocol, data, or trial results have not been altered, anyone can use the original clinical trial protocol’s unique digital signature to create a new bitcoin key. If the newly created bitcoin key differs from the existing bitcoin key on the blockchain, then changes have been made to the protocol. These changes could represent fraud or other unauthorized changes, ultimately undermining the trustworthiness of that clinical trial. However, if the newly created bitcoin key is identical to the bitcoin key on the blockchain, then this would serve as verification that the clinical trial protocol, data, or trial results were not altered or manipulated in anyway. This system was recently applied to a cardiovascular diabetes trial which passed peer review on F1000Research, an open science publishing platform. The successful implementation of Irving and Holden’s system into a clinical trial could lead to possible adoption on a broader scale in the future.

Impact of Incorporating Blockchain Technology into Clinical Trials

The most significant advantage of utilizing blockchain technology in clinical trials is increased transparency and trustworthiness of clinical trial protocols and results. Researchers will no longer be able to hide side effects of drugs that come to light in the trials or selectively report clinical trial data. Selective disclosure of clinical trial data is a major concern facing clinical trials, a concern highlighted by a 2001 clinical trial of paroxentine. Paroxentine was intended to treat depression in teenagers and the original clinical trials declared paroxentine an effective medication for depression. However, it eventually came to light that the supposedly safe and effective antidepressant actually increased the risk of suicide in teenagers. The researchers deceived regulators and the public by selectively reporting clinical trial data. Deploying Irving and Holden’s blockchain system, the paroxentine researchers would have been unable to deceive regulators and the public as anyone could have attempted to verify the accuracy of the reported data. This new system has the advantage of bringing transparency to clinical trials. If researchers attempt to manipulate trial protocols or selectively report trial data, regulators and the public at large will be able to easily spot this tampering and discredit the trial’s conclusions.

This new system also has the ability to prevent outcome switching. Outcome switching occurs when the researchers shift the attention of the clinical trial to fit the results. Instead of reporting a clinical trial as a failure, researchers can use “outcome switching” to tailor the results to a new desired outcome. Deploying Irving and Holden’s blockchain system, researchers will no longer be able to use outcome switching to deliver positive results to regulators and drug companies.

Studies have also found that many clinical trials fail to disclose their clinical trial protocols altogether until the trial is completed. This behavior raises questions as to what the actual protocol was and whether the protocol was tailored to fit the results after the fact, a severe form of outcome switching. With a blockchain platform, researchers would have to uploaded the protocol to the blockchain before clinical trials commenced. Researchers would still have the option to keep the protocol hidden until the trial was completed, which could be useful in commercially sensitive trials. However, because the protocol must be uploaded to the blockchain prior to commencement of the trial, there is no possibility that the researchers could alter the protocol mid-trial and hide that change from regulators or the public.