Using blockchain to strengthen clinical trials

Blockchain, a buzzword dating back to 2017, can be described as a type of distributed ledger that keeps logs of transactions that occur providing immutability, security and transparency.

Blockchain’s security has been focused on the most when discussing its potential in healthcare. Other aspects of it have included its ability to be tracked and to be accessed by anyone with a key. While those are indeed the primary intended uses of the technology, there is another one that few people think of: clinical trials.

 Almost thirty-one thousand clinical trials were run in the U.S. last year alone.¹ A problem with many clinical trials is that the information received about the subjects is incomplete or incorrect. Eighty percent of clinical trials aren’t able to be replicated for that reason.² A trial that can’t be replicated isn’t always the result of deliberate fraud, but it still slows down the pipeline of working medicine and can potentially delay life-saving treatment.

 Providing transparency

 With blockchain technology, every transaction on the chain is secure and noted.  This prevents selective reporting of data as well as discrepancies between the desired outcome in the initial phase and in publication. All of the data can be accessed by anyone with a key, thereby making the trial data easy to confirm and impossible to change later without the chain marking it down. Patient consent forms can also be stored on the chain in case there is an allegation of lack of consent or some ethical violation related to that.

If patients drop out, their data can still be recorded. Regardless of how the data is later analyzed, it can be first recorded in the record before the data is collected. This can eliminate the allegation that the method of data analysis was chosen after the fact to make the results seem more impressive or important. Different blocks can be set up at certain points to make sure the study procedure is followed throughout the trial. If any adverse reactions occur from the drugs or devices involved the real-time reporting of the data on the chain can prevent further research from being done.

Several large medical companies, such as Pfizer, Amgen, Merck and Sanofi, have expressed interest in blockchain for testing new drugs, medical procedures, and devices. The ultimate integrity of the central authority would most likely be the FDA due to their role in approving medicine and overseeing trials. (A public blockchain network is available to anyone who signs up for the system, but the medical blockchain would be a private network, where only authorized users would sign up. While the private network can be altered by one administrator, medical networks would most likely be run by a group who would have to vote upon any changes added to the hash.)

 Nature Communications recently published a short account of a study uploaded to a blockchain network. When one of the designers tried to edit the data that was already there, the system would not let him. Instead it created an appended change to the data, with the system noting the time, date, and key used to access the chain. After trying this, he tried to change the notation of whether the patient had received a placebo or the tested drug. Once again, the system showed exactly what had been changed and when.

Blockchain cannot prevent inaccurate research completely as it still requires that data be entered correctly in the first place, and someone will still have to match up the data correctly. But the potential is there, and if utilized then trials may be faster and more accurate and new treatments might get on the board faster.