DATA MANAGEMENT TECHNOLOGY & The blockchain hyperdrive


Frank Leu, CEO and co-founder of Novapeutics, explains how blockchain’s immutable database architecture enables machine learning and AI to drive a hyper-efficient clinical trial.


than $350bn per year, based on a report made by ClinicalTrials.gov. Currently, not only the cost of running clinical trials is astronomically prohibitive, but the logistic challenges are also numerous, such as patient recruitment and retention, incomplete or incomprehensible data, and delays that can add an average of almost a year to each clinical trial. It is no secret that a vast amount of money and resources are wasted on misuse, duplications, systematic failures, needless repetitions, inadequate communications and flat out inefficiency. The internet and digital revolution began more


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than three decades ago and, while other industries have already benefitted greatly by improving operating efficiency, the clinical trial process is


56 | Outsourcing in Clinical Trials Handbook


he costs of running clinical studies combined with resources used in global drug development is estimated to be greater


still significantly lagging behind. Lately, other industries – such as financial, real estate and the consumable supply chain – have taken a leap forward by adopting blockchain technologies and seen a greater reduction in cost, and increase in operating efficiency. Clinical trials have many stages and many different places where they could be better optimised. To understand the overall picture better and its challenges, I will briefly review how a standard clinical trial flow works and how blockchain technologies could provide a much-needed solution.


A brief overview Phase I of a clinical trial usually only lasts for a few months and is designed to assess the safety of the drug, and examine whether it has any acute toxicity. This phase usually consists of a small


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