author image

Amara Bharathy, Senior Biostatistics Programmer   |     |  Clinical Biometrics

Poster Img

If you have searched for emerging trends in technology, you couldn’t have missed Blockchain. While some of you might have known this technology as the one that drives bitcoins, I request you to take a step back, as it does a lot more than just that. In this article I have tried to throw some light on Blockchain and how it might bring about a renaissance in clinical trials.

What is a Blockchain?
Going by Wiki “A blockchain, originally block chain, is a growing list of records, called blocks, which are linked using cryptography. Each block contains a cryptographic hash of the previous block, a timestamp, and transaction data (generally represented as a Merkle tree root hash).” Yes, it sounds a bit vague. Let me explain in simple terms.

Let’s say that we start with some datapoint “A”, which is stored in, what is called in blockchain terminology, a block. Whatever change is done on this block “A” creates another block “B” in the chain. The block “B” holds the change that is done in datapoint “A”. Both these blocks are connected by cryptographic messages or hashes. What makes these simple blocks powerful is the way they are protected (encrypted). Each new block that gets added, distributes its hash to the network, so that the whole chain gets synchronized.

    Every block within blockchain has three parts:
  • “I know.” (The data of the block)
  • “I know that you know.” (Hash synchronization along the linear chain)M
  • “I know that you know that I know.” (The hash of the previous block)

Right from setting up a clinical trial, data management till decision making, there are a lot of phases that need auditing. Trust is the foundation for the establishment of clinical services for patients. The required trust is bi-directional (i.e., patient to clinical research professional and vice versa). For example, trust between a clinical research professional and a patient involves the belief that the patient is sharing their experiences and conditions truthfully and honestly. Similarly, trust between patient and clinical research professional involves consent-driven sharing of patient’s personal health information for research purposes.

With the ability of systems to use cryptographic keys (hash) to authenticate a user, the risk related to sensitive patient health data leaks reduces drastically. Moreover, use of predefined governance rules would enable an adequate level of privacy. Furthermore, authorized users can define and manage the governance rules of a blockchain solution around predefined access and control permissions to assure the appropriate levels of privacy versus transparency and ensure that only entitled parties (like CROs, the central lab, statisticians, etc.) can see the necessary data. This is during the study setup stage. When the study goes live, data monitor checks for the data integrity in the clinical site; while in data management phase, there is a need to track which data point from the EDC goes where in SDTM/Analysis datasets.

The cryptographic keys or the hash forms the audit center of this blockchain. Whenever there is an erroneous entry to the chain, this audit center performs 2 simple checks – looks for the previous hash information in the chain, and if it is present, passes this information to the entitled users/admins of the blockchain, wherein they must authenticate the new block to the chain. This attribute can be used in clinical data management aspect. Every data point can now be considered a block, and no block in this chain will ever go unaudited! Imagine the scenario now. The data from EDC are made into blocks and verified as and when they are added, saving a lot of time getting wasted in performing checks. All that we need to do is to add the algorithm of data checks along with the hash authentication step.

Data Integrity
Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Blockchain ensures that events are tracked in their correct chronological order, which largely prevents any back and forth communication after data collection.

Within blockchain each transaction is cryptographically validated, thus asserting integrity. Further, each transaction with Blockchain is timestamped. This information is transparent, and user can own their copy of the proof of the time-stamped data.

Another unique feature it has is the decentralization of data. No one owns the data store; it is controlled by users and is not ruled by any trusted third party or central regulatory instance. Trust is coded within the algorithm and maintained by the community of users. Blockchain architecture allows for storing proofs of the existence of data. As the proof of data is the data of proof, we believe that this is a paradigm shift in clinical research methodology.

The above image differentiates the traditional approach of having a central repository that stores the information versus the decentralized blockchain approach.

Blockchain technology is a major opportunity for clinical research: it can help in structuring more transparent checkable methodology; when a set of core metadata is defined it can help check clinical trial integrity, transparently and partly algorithmically.

Ultimately, Blockchain can lead to the structuring of community-driven internet of health data, gathering researchers and patient communities, social networks and Internet of Things on a global dimension, with features of individual granularity, decentralization and security to ensure easier and transparent analysis.

Have any thoughts or questions on this? Please email us at info@zifornd.com