As of Jan. 5, 2022, over 400,000 clinical trials were being conducted somewhere in the world, according to ClinicalTrials.gov. Such trials offer invaluable insights into new treatment regimens, new medications and new devices, while at the same time making available to patients certain treatments that are not otherwise accessible to them.
Clinical trials have in the past done things like enable the National Heart, Lung and Blood Institute (NHLBI) to find a better treatment for moderate persistent asthma. They have enabled a women’s health initiative undertaken by that same organization to determine that hormone therapy, when used by menopausal women, results in an increased risk of heart disease.
Additionally, they have enabled George Washington University’s School of Medicine and Health Services to partner with the Sabin Vaccine Institute in Washington, D.C., and in time develop the world’s first vaccine for hookworm, which afflicts over a half-billion people around the globe..
As invaluable as clinical trials have proven to be, they can be improved through the use of blockchain technology. Blockchain, a decentralized, immutable digital ledger – think of it as a transaction record – enables those conducting such trials to create secure databases that ensure patient privacy, marking that information accessible to healthcare professionals in a timely fashion.
Rama Rao, CEO of the New Jersey-based business consultancy Bloqcube, told the European Pharmaceutical Review that blockchain can make data available to researchers, no matter where they are in the world – and that they can “look at records years after the fact and know that the data that is held in that block of that chain has full integrity and has not been tampered with.”
Moreover, he added:
“(B)lockchain systems have the benefit of being used in a decentralized way. In effect, that means that, in tomorrow’s world, clinical trials could be run in a patient’s home and retain strong governance mechanisms. This also levels the playing field, so whether you are in rural Africa, India or Latin America, or in a major hospital in New York, Paris or London you should be able to achieve similar scientific results and the same level of data integrity.”
In other words, it makes data more accessible, ensuring that it can be retrieved more quickly and efficiently. At the same time understand there is enough flexibility within a blockchain framework to provide data with password protection, depending on the owner’s preference – something that is obviously crucial, given how sensitive such data can be.
Certainly the efficacy of blockchain in clinical trials has been explored a great deal. IBM and the Canadian pharmaceutical company Boehringer Ingelheim began looking into it in 2019, and a year earlier the Food and Drug Administration launched a pilot program with four hospitals that would make it possible for the FDA to share information with healthcare organizations and providers, while at the same time keeping patients’ information secure.
Lauren Neal, principal at the management and IT consultancy Booz Allen Hamilton, which partnered with the FDA on the project, explained to the website GCN.com that the latter requires “a solution with off-chain components … with cryptographic algorithms to create user sharing.”
Rao has said that blockchain “is not a magic bullet” when it comes to clinical trials. As the amount of data increases, he added, so too do concerns about privacy and security. There are also regulatory issues and the far more basic concern about connectivity in remote areas.
Generally, though, Rao sounded an optimistic note about blockchain on the clinical-trial front – how it can further research while at the same time improving outcomes. And it is his belief that the concerns that have emerged today can be alleviated as the technology continues to evolve in the years ahead.