Data management in clinical trials
Clinical trials are essential to determine the safety and viability of new drugs intended to enter the market or to find alternative uses for drugs that are already commercially available.
Pharmaceutical trials generate a vast amount of data, and meaningful collection and interpretation of such data are crucial to determine the integrity and validity of the outcomes.
The problem arises when trying to manage medical records, patient-reported data, drug safety and dosage parameters, data arising from biological samples, and data coming from many other sources. There is a lot of information available, and investigators are partial to taking the somewhat misguided ‘more is better’ route. This blunt approach often places a burden on trial participants in the form of countless and repetitive questionnaires, multiple sample taking, and other annoyances at times when the subject’s health may be in serious jeopardy. Furthermore, much of this data might never be looked at, analyzed, or used in any way.
The collection, analysis, and validation of clinical data is, therefore, an inherently complex and costly process that involves a lot of moving parts, which quickly becomes its own Achilles’ Heel. There are simply too many sources and many ways in which data can be misinterpreted or maliciously altered or misused.
Current inefficiencies
Take Case Report Forms (CRFs) and patient diaries, for example. These are usually paper-based data collection methods that are still widely used today. CRFs typically are specific to each trial and are utilized by hospitals, or whatever institution is running the trial, to collect patient data. Patient diaries are given to study participants so they can record medicine intake times and doses, any worsening of symptoms, etc.
CRFs and patient diaries are perfect examples of the inefficiencies currently faced by clinical trials, as both methods rely on hand-written notes from either patients or study staff. Either way, these notes can contain ambiguity, which might lead to being misread or misinterpreted, potentially compromising the study outcome and patient safety. Paper-based data is costly and awkward to store and manage, and can easily be misplaced or tampered with, which casts heavy doubts about its validity and reliability in a clinical setting.
Overall, only one in ten drugs being tested actually makes it to the market. This is a huge failure margin, which means a lot of time, effort, assets, and data being wasted in the process.
Blockchain as a solution to clinical data management
Clinical trials pose challenges due to their very nature. Blockchain technology can address some of them.
At its core, blockchain is a decentralized ledger that does exactly what it says on the tin. It is a chain of blocks that stores transactional data. All existing nodes in the network validate the transaction, which becomes immutable, i.e., it cannot be changed. Simple yet incredibly powerful and versatile. Many industries such as manufacturing, Fintech, entertainment, supply chain, and many more have already benefitted from blockchain-powered platforms.
The current workflow of data during the lifespan of the clinical trial is fundamentally flawed, for the following reasons:
Data is created from multiple sources (hospitals, clinics, the study participants themselves, and so on). This data is entered into a centralized database management system, which is usually proprietary for each of these organizations. This amalgamation of data is then collated and analyzed by yet another set of specialized agencies that store it and manage it in their own preferred format. This means that the same data might be analyzed and presented to regulatory authorities in different ways and formats, creating confusion. The current data workflow hinders collaboration.
Blockchain offers a single, homogeneous, cohesive platform where all stakeholders can share and validate data through smart contracts and a consensus algorithm that ensures that all nodes (stakeholders in this setting) are in agreement before data becomes immutable.
But the potential benefits of blockchain in a clinical trial setting go far beyond data management. Blockchain can also improve efficiency in the subject enrollment process. By storing a patient’s medical record on the blockchain, sponsors can quickly access it and determine the patient’s suitability for an upcoming trial, for example. An additional benefit of this is that the participant can be issued their due compensation via blockchain, without the need for costly third-party institutions such as banks.
Conclusion
Blockchain is fast emerging as the go-to piece of technology that enables a transformative leap for many industries, opening up new ways to do business and creating revenue streams.
When applied to clinical trials, blockchain can remove the current inefficiencies found in the flow of data during the trial, streamlining data management and sharing, and ensuring data transparency and immutability.
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