The fundamental power of blockchain – now beginning to be applied in the real world, and well beyond the world of digital currencies like bitcoin – lies in its essence as a tamperproof distributed database ledger. It’s no wonder that financial services firms are exploring blockchain on a massive scale, but the pharmaceutical industry can generate tremendous value by applying blockchain technologies to multiple functions including the clinical trials process.
Getting a new drug to market takes an average of 12 years and costs $5 billion, and a large part of that effort is devoted to clinical trials. Trials generate enormous amounts of data that are shared among the pharmaceutical company’s internal teams and contract research organizations (CROs) and, ultimately, with the Food and Drug Administration (or analogous regulatory bodies around the world). Establishing that a new drug is effective and safe is of course a scientific challenge, but ultimately it is also a data challenge (and proving efficacy and safety is very much a data challenge). Blockchain represents a powerful solution to ensure the integrity of clinical trials data from start to finish.
The perils of not ensuring that data integrity are enormous. In 2012, a global pharma giant “agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug,” according to the New York Times (July 2, 2012).
Even absent the threat of fines, data integrity will accelerate the development process and contribute substantially to success in the approval process and help convince the clinical world of practitioners and patients that a drug does what it’s supposed to do and does it safely.
Data volumes have grown dramatically in pharmaceutical firms – and like many enterprises, there has been a natural tendency to “silo” data, which can facilitate the introduction of errors, and costs, when this data is inevitably shared. We have created solutions to address this using big data analytics and the cloud. For example, we built a data lake for a major global pharmaceutical company that facilitates data integration, sharing, and mining for insights. (Note well: Pharmaceutical firms are not the only enterprises with data silos. This is an issue for lots of data-intensive industries, and an issue that is increasingly important to address with a next-generation analytics solution.)
We already know that a centralized, high-performance data solution can accelerate the clinical trials process. But we believe that a blockchain-powered data ledger solution for clinical trials could be even more effective. It would generate a much higher level of trust among all concerned and enable a dramatic increase in data transparency. We envision proceeding in a phased way starting, say, with the pharma internal research team and its CROs, then extended to the FDA and other functions of the enterprise (manufacturing, marketing, sales, etc.) and even to patients.
Because of the innate immutability of blockchains – a distributed ledger uses a defined consensus mechanism that prevents modification and ensures the coveted single source of truth – the underlying data could be easily revealed and would never be in question. Blockchain platforms preserve all additions to the data stream and all transactions involving that data verifiably and permanently. And blockchain networks make it easy and safe to use data by multiple parties in ways that ensure privacy and integrity.
There are a number of different blockchain protocols in use today (some in the form of operating systems, others provide blockchain as a service), but most are far being from market-ready application solutions. Blockchain solutions require advanced professional service capabilities and a true digital architecture to work.
While blockchain is relatively young, it is quickly becoming a viable possibility for mission-critical applications like the management of clinical trials. We believe there are many other possibilities for this powerful technology, in pharma and many other industries.
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