Blockchain to revolutionize clinical trials

The blockchain technology is the biggest achievement of cryptography of the last decade. There are few industries craving its core ability to provide guarantees about data safety and authenticity as much as the industry of clinical trials. Source Data Verification (SDV), which demands nowadays 20–30% of the clinical trial budget, becomes unneeded when blockchain disrupts the pharma.

However, let us start from the very beginning of that story. Hashing is the cornerstone technology of the blockchain. The algorithm takes a stride of arbitrary data of any size and produces a ‘hash’ which is a big number from a selected range with two main properties:

  1. It is very unlikely that different data would have the same hash and
  2. That calculation is reproducible by anyone knowing the algorithm.

The blockchain is used for storing hashes of a combination of important data with an exact time of saving (timestamp). It can then be used as evidence that the data existed at a certain moment and was not forged or altered.

These evidences cannot be erased because the blockchain protects them. That allows their use in clinical trials by keeping track of every step and saving a timestamp; e.g., when source data is entered at a clinical site and transferred into Electronic Data Capturing system of a clinical trial, there is no need to check the correctness of the transfer anymore. Blockchain does it for us.

For pharma, it is vital to make clinical trials more reproducible, ensuring data for each step is not falsified. For that, every document prepared before a start of a study (informed consent, study protocol, study plans, regulatory documents, etc.) should be timestamped to create a proof that it existed in that exact form before the start of the trial. It is especially important for pre-planned endpoints. In addition, when the trial starts, ongoing reports are treated the same, for example every monitoring visit report. Each measurement in a trial can be notarized to be safe from forgery and corrections that violate a protocol, good clinical practice, or even the law. This technology would increase the credibility of clinical trial results. The notarized data exists outside of the blockchain boundary in safe storage and only digital thumbprints of it are inside. Such a permanent catalog of documents significantly reduces the costs for audits, file reviews, lost documents, post-closing, and litigation. Blockchain can also help with pharmaceutical supply chain management tracking drugs for better accountability and the supply chain integrity.

Thus blockchain is used as a notary service and has the potential to reduce systemic risk, increase data quality, and decrease risk of fraud by a notarized process because of the programs open and decentralized nature.

Data safety guarantees

With enormous amounts of clinical trial data being generated every day, and pressures from commercial and regulatory agencies to overcome big data hurdles, it’s becoming obvious that legacy data management systems are not powerful enough to process and retain the data extracted from all of the current research studies, posing problems for patient privacy, as well as data integrity in general.

Another major problem in the pharmaceutical industry is patient data and its accessibility. It is imperative for investigators to have the ability to locate individuals for particular studies. With current technologies, however, data is scattered across multiple proprietary systems that are often independent and incompatible with each other, making it extremely difficult to recruit individuals for trials.

To make matters worse, even when investigators do find enough patients to initiate an effective clinical trial, the quality of patients for that particular treatment or medical condition could still be an issue, or even result in an inaccurate study with false positive or false negative data. Blockchain can help prevent that.

Recently, a study was conducted to better understand and heighten awareness of the difficulty of enrolling patients for clinical trials, and the results were dire. Researchers examined how many patients were aware of ongoing and available clinical trials and found that a mere 16% of patients were actually aware of relevant clinical trial options during the time they were considering treatment options. That means that approximately 85% of patients had no idea that valuable clinical trials were in operation or that they would have benefited from treatment that the trials offered. To think that so much money and time is spent on developing drugs and almost none is spent on finding patients for clinical trials is astounding, and the public should be made aware of it. Blockchain technology will be able to directly increase the quantity and quality of patients recruited for clinical trials in a number of ways. This type of distributed ledger could allow individual patients to store their medical data by anonymous methods, thereby making it visible to trial recruiters, who could then reach out to the patients if their data qualifies for the clinical trial. It could also streamline the communication between doctors and patients during the trial. Blockchain has the tools to provide smart contracts that endorse transparency and traceability over clinical trial sequences, and can provide financial incentives for a patient’s participation and sharing of their data.

There are so many rewarding benefits for integrating blockchain technology into clinical research, from tracking and sharing data to the needed transparency and privacy concerns for patients. The global impact of implementing this technology will be both momentous and timely. The coevolution of blockchain and clinical research studies is still in its infancy, but researchers are continually collaborating to find new ways of cutting costs and saving time for a wide range of applications in the clinical trial setting. Ultimately, their efforts will result in cheaper drugs for everyone.

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Kalyan (Kal) Kalwa

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