The complexity and cost of clinical trials have augmented radically in recent years. Regardless of technological expansions, there has been a dip in clinical trial process efficiency. Data suggests that delay in drug development by one day leads to revenue loss of about $8 MM for the industry.
Data hack, theft, or infringement are major issues which cannot be ignored when it comes to drug development. Trained professionals or hackers determine and manipulate vulnerabilities in a computer system and/or network to gain unauthorized access.
In principle, blockchain is a database which is decentralized. It may be regarded as a pooled set of information, which is shared, immutable and irrefutable – if changes have to be made, the database cannot be altered without the consent of relevant stakeholders.
Blocks are added to the blockchain in a chronological and linear sequence. Each block is linked to a preceding block and holds a timestamp. Also, blockchain eliminates the need to record the same data separately and thus eradicates the inadvertent errors that occur due to the need to capture duplicate records which are redundant.
Same philosophy, if applied correctly in the clinical domain, will eliminate losses ensuing security lapses, duplication of work, and generation of erroneous data due to redundant operating procedures.
Blockchain has a network of computers which has identical information. The system has controlled access and the same information is available to all the parties. It is like a big central library/ledger where every single transaction, transfer, transcription, and transformation of data is registered. The data listing is time stamped, immutable, and maintained with an audit trail. Any unauthorized access to the same, with the negative intension of manipulation or modification, is not possible. Information on blockchain cannot be erased or changed – only the data owner has the right to decide who can access the information. Thus, for the clinical trial process, it is the subject who is the owner of data, making the blockchain based model completely patient-centric.
As data across all the computers in the network is similar, the problem of interoperability is also resolved. In future, of course with required rights, this will compel the industry to align and create an ecosystem which will enable the retrieval of individual patient-specific information across all databases, within and outside the organizations, irrespective of geographical boundaries.
The blockchain technology works on the principle that a hash algorithm is run over the piece of transaction of data to create a secure hash. This output is a unique hash – it stores only the transaction and not the data. Every single hash is clustered together into a big ledger and this ledger is kept in the block. Individual blocks are associated with the previous one to make a chain, the blockchain. This alludes to the fact that anyone with only the hash value cannot go back to retrieve the transaction information, and ensures data protection and complete privacy.
Retrieval of information is managed by Smart Contract. It is a pack of code which is associated (stored) within the blockchain. To execute any event (pull information or perform transaction), they need to be triggered by meeting certain pre-required conditions.
The ability to exchange data with CROs and other clinical systems is restricted by data format and fixed structure limitations enforced by each transactional system. Operational data exchange is usually inconsistent and aged data, limiting decision support.
The key drivers of blockchain adoption are listed below:
Single shared source of truth and Proof of Existence of document/data transaction
In the traditional process, each participant will have separate record for the same set of information, which increases the chances of fraud or mistakes. With blockchain, the same record is used by all stakeholders - it cannot be changed and is tamper evident. The real power of blockchain is that it can provide evidence that a unique/distinctive event has occurred at a certain point in time.
Improves Work Efficiency
In traditional process, each individual works on separate records for the same set of information; the procedure and data validation is inefficient. With blockchain, all stakeholders must consent to a change in a particular data, reducing overall loss of time.
In traditional process, work is dependent on cumbersome paper-based procedures with associated costs of printers, fax machines, copiers, toner cartridges, ink, and cabinets/office space for storage.With blockchain technology, processes will be paperless. This improves data storage and electronic communication, resulting in faster time to respond with standard reports
If a patient has to get himself/herself enrolled for a clinical trial process, he/she has to get all the prescribed tests done again, even if the same were conducted not very long ago. This is because the site-team cannot pull the information from common ledger (database) for that particular patient. This further emphasizes on the need for real-time functional interoperability.
If the subject, the owner of the medical records, grants permission, the investigator can access all medical records (medical history). This is possible by leveraging blockchain technology. Also, the likelihood of data fraudulence is eliminated since every sequence of report submission is tamper-resistant and immutable.
Current Process: Data Aggregation (Pooling) is next to nil/difficult
Future Process: Improved Data Analytics from Data Aggregation
Another use case may be related to the future use of lab biospecimen samples (blood, genetic, etc.) collected from clinical trials. Once a study-specific biospecimen is collected and the company wants to use the same for research in the future, the major roadblock is encountered when they have to track back to check whether consent was obtained for such use from the subject when the sample was initially collected (which could have been few years back).
Also, even if the consent is somehow available from the patient, how do they correlate the same with ever-changing, country-specific, and varied regulations? Currently, across many big pharmaceutical organizations, clinical specimen tracking is performed by manually merging available data from various sources into a single spreadsheet.
Blockchain technology can solve the problem and provide a connecting link to map the same. It can facilitate tracking and precise retrieval of the unique patient-specific lab sample and inform about consent (both obtained in the past). It will help correlate the feasibility of use by mapping with country-specific local regulations mandated by government/geographic regions and regulatory bodies.
USE CASES, few other examples
CLINICAL RESEARCH TEAM
LIST OF USE CASES
Drug Safety prediction
Aid in Site selection
Facilitate patient enrolment
Easy availability of historic information
Inform consent management
Biospecimen sample tracking for future use in clinical trails
Drug Shipment & Therapy tracking
Clinical Data Management: Supply Chain
Version Control of Other Essential Documents
Payment and finances
Use of Block Chain in combination with AI/ML (Artificial Intelligence /Machine Learning) in Clinical Data Management (CDM)
Document Digitization Shared Visibility Reduced Traceability Time From Days to Seconds
Risk Based Monitoring
Smart Protocol Design
Clinical Data Query Management
Assist source data verification process
Site assessment and monitoring to detect critical data and processes (AI/ML)
Scientific/historical data mining of structured / unstructured data (Cognitive Computing)
Real-world data driven protocol design (NLP support)
Measuring and learn on investigator’s performance (Machine Learning)
Identify past Disqualifications or Restrictions
Unearth data points missed by traditional screening, sourcing (Cognitive, Orchestration)
Patient assistance in learning about trial, disease, visit scheduling (Virtual Assistance, Chatbots)
Analyse EHR / RWE data on patterns to better identify qualified patients for enrolment (Cognitive Computing)
Handling continuous and variety of data (AI/ML, Orchestration)
Discrepancy management, query for completeness instead of content (AI/ML, Cognitive)
The business and process changes in clinical trials will directly and indirectly impact function of Clinical Data Management
The biggest problem which the clinical research industry faces is the lack of clarity on application of blockchain technology in terms of implementation, integration (with current process/platform), and applicable regulations. Most of the pharmaceutical organizations still believe that it is better to be a fast follower than the first implementer. Some of the perceived limitations are -
Need for trust
Absence of a central controlling authority, one single central organization or state
Summary of Mechanism of Blockchain Application
Blockchain technology helps introduce transparency and accountability by providing synchronized, authentic, and secure data for submission to the regulatory agencies from trials. Blockchain offers an opportunity to form a patient-centric environment with real time access to precise information.