DATA MANAGEMENT TECHNOLOGY &
number of healthy, paid volunteers. This is also where the drug is measured on how it is absorbed, metabolised and excreted in the patient subject. Any acute side effects during this phase are also examined and documented. Approximately 70% of drugs tested end up passing this phase of the study. Common issues at this phase that could be addressed by blockchain are related to patient recruitment and retention, clinical and patient data management/analysis, and payment portals.
“The internet and digital revolution began more than three decades ago and, while other industries have already benefitted greatly by improving operating efficiency, the clinical trial process is still significantly lagging behind.”
The next phase of a clinical trial is designed to
test a drug’s efficacy; the time of study could range from months to a couple of years. Phase II studies are generally done in a randomised fashion, with one group of patients receiving the drug and the other receiving a placebo. In addition, these studies are completed in such way that neither the participants nor the researchers know who is receiving the drug – at times this is referred to as a ‘blinded’ study. The success rate for passing this phase is around one third for the drugs in trial. The value proposition for implementing blockchain data management during this phase would be for aspects such as enhanced patient retention, efficient data management/analysis, enforcing data integrity and reducing human error. Generally speaking, clinical trial phase III is considered to be the most expensive and scrutinised testing phase – it usually takes several years to conclude. This phase could include several hundred to several thousand patients depending on the disease, and it is often conducted around the world. At the end of this phase, the drug’s effectiveness to the disease interest should be conclusive and around 70% of drugs that made it into phase III end up passing this phase. The budget for this phase is the largest among all phases, due to the numbers of participants in making significant statistical analysis of a drug’s effectiveness. Due to the large size of patient participants and increase in stakeholder numbers
world-wide during this phase, any frictions that exist cause an expensive amount of time and money to overcome. Blockchain database could reduce friction in the following components, such as in data tracking and analysing, patient recruitment and retention, central laboratory management, investigator site management, data integrity checks and payment portals. Clinical trial phase IV is when the drug has
received FDA phase-III approval to release to the public for use, and generally entails monitoring its long-term impacts on the following: the quality of life, negative health effects and drug-to-drug interactions. The drug is allowed for continual use as originally intended if no questionable problems arise. If a problem does surface, it would then be taken off the market and re-evaluated. Due to its immense patient-population reach, the current data-tracking and reporting is severely limited in its consistency and accuracy. Therefore, by implementing the blockchain database, it could overcome many of the above-mentioned problems. Primarily, the blockchain comes equipped with its core database capabilities, providing data-tracking and management that will surpass the existing systems in terms of efficiency and immutability.
Reap the rewards Numerous progressive database solution providers for clinical trials have already adopted the blockchain database architecture. The overall clinical trial spending in all trial phases is high and very lucrative for vendors, therefore, database solution providers are competing to address existing procedural and infrastructural weaknesses in clinical trials. All done in an attempt to be the first one to claim leadership in the emerging area in order to reap the rewards. Specifically, the blockchain technology can be
used to address some of the following key areas:
Tracking every record and exchange of clinical information across multiple platforms and devices in a secure matter, affirming clinical data security.
The FDA review process requires sponsors to turn over the clinical trial data that are trustworthy, with appropriately written handling procedure in place to demonstrate its immutability. The blockchain database is known to be an immutable transactional ledger system that has intrinsic proof for retaining its utmost recording data integrity.
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