THE FUTURE OF CLINICAL DATA MANAGEMENT: INTEGRATION OF BLOCKCHAIN TECHNOLOGY
ABSTRACT:
Blockchain technology has disclosed unprecedented opportunities in the healthcare sector by unlocking the true value of interoperability. specifically, the striking features of blockchain technology, such as data provenance, transparency, decentralized transaction validation, and immutability can help to compensate for stringent data management issues. Several research studies show that blockchain solutions help to improve patient retention, data integrity, privacy, and ensure CTs compliance. and we discuss the integration of blockchain technology and the future of clinical data management.
Keywords: clinical data management, blockchain technology, integrations, future of CDM.
INTRODUCTION:
The introduction of the latest competitive information technologies in all spheres of human activity to automate processes, reduce the share of physical labor, and minimize the impact of the human factor is the main strategic goal. Today, medical information technology must meet four requirements :efficiency safety ,novelty ,and ecnomic benefits. Clinical data management is a vital vehicle in clinical trails for 1.data collection 2.data integration 3.system/data validation. And blockchain integration services to meet our needs and enable multiple team members working off the same design plan to track changes in real time to ensure planning and performance are aligined. Blockchain supports API based integration .
WHAT IS CLINICAL DATA MANAGEMENT:
Clinical data management is a process of collecting ,entering, validating or cleaning the data obtained in clinical trial.
Pharmaceutical industries relies on electronically captured data for the evaluation of medicines ,there is a need to follow good practices in CDM and maintain standards in electronic data capture. These electronic records have to comply with a Code of Fedral Regulations, 21CFR Part 11.
OBJECTIVES OF CDM
The integrity & quality of data being transferred from trail subjects to a database system.
That the collected data is complete and accurate so that results are correct.
That trail database is complete and accurate , and a true representation of what took place in trail.
The trail database is sufficiently clean to support statistical analysis , and its subsequent presentation and interpretation.
IMPORTANCE OF CDM ;
CDM has evolved from a mere data entry process to a much more diverse process today.
It provides data and database in a usable format in a timely manner
It ensures clean data and a ‘ready to lock’ database.
a. That collected data is complete & accurate so that results are correct.
b. That trial database is complete, accurate& a true representation of what took place in the trial
c. That trial database is sufficiently clean, to support statistical analysis, its subsequent presentation & interpretation.
SCOPE OF CDM :
The main scope of CDM is to collect, validate, and analyze the clinical data
Design and development of data collection instruments such as paper CRF, electronics CRF, Clinical database, etc.
Design and development of tools for validation such as Eidt Checks, User Acceptance Testing, etc.
WHAT IS BLOCKCHAIN TECHNOLOGY ;
A blockchain is a decentralized, distributed and public digital ledger that is used to record transactions across many computers so that the record cannot be altered retroactively without the alterations of all subsequent blocks and the consensus of the network. In simple words blockchain technology is an advanced database mechanism that allows transparent information sharing within a business network.
Examples are legal, supply chain, government, energy food, retail, healthcare insurance, travel and hospitality& education services.
WHY USE BLOCKCHAIN
Blockchain technology offers new tools for authentication and authorization in the digital world that preclude the need for many centralized administrators. As a result it enables the creation of new digital replaces.
- Advantages: highly secure.
- Decentralized system.
- Automation capability.
SCOPE OF BLOCKCHAIN TECHNOLOGY :
Blockchain in healthcare has the potential to help solve these problems by providing a secure and transparent way to store and manage clinical trial data.
With blockchain, each step of the clinical trial process would be recorded on the blockchain
Making it easy to track data and identify errors.
CHALLENGES OF BLOCKCHAIN TECHNOLOGY:
Security issues
Low scalability
Low interoperability
High energy consumption
Low workforce availability
FUTURE OF CDM:
Clinical data management is a critical phase in clinical research
Which leads to generation of high quality, reliable and statistically sound data from clinical trails .
These helps to provide a drastic reduction in time from drug development marketing .
Regulatory agencies is depend upon a trust that clinical trails data presented are of significant integrity.
To ensure confidence in results & conclusions presented by pharma company and it is important to obtaining the trust to adherence to quality standards& practices.
CHALLENGES OF CLINICAL DATA MANAGEMENT:
DATA MANAGEMENT : Massive amounts of data are generated everyday in a lab which is critical and laborious.
DATA CENTRALIZATION : Central database of patient and products seamless , secure ,and round the clock accessible.
COMPLIANCE : A secure chain of custody of records, approvals at multiple levels, maintaining adult trail.
ETHICAL CONSIDERATIONS: protection of rights, privacy of research participants.
REAL -TIME TRACKING : Real -time tracking of all reports and tasks being completed in his lab.
CONCLUSION:
The blockchain preserves a complete ,up -to-data history of all trail-related data, including the clinical report ,visit history, subject info etc., which would track the enrolled subject during the clinical trail study
Blockchain technology is a major opportunity for clinical research and for the clinical data management ;it can help in structuring more transparent checkable methodology and provided a set of core metadata is defined ,can help check clinical trail integrity, transparently and partly algorithmically. Ultimately blockchain can lead to the structuration of some kind of community-driven internet of health data, gathering researchers and patient communities ,social networks and internet of things dataflows, at a global dimension , with features of individual granularity , decentralization and security and with transparent interactions to ensure easier and more transparent analysis.
REFERENCES;
Ramadoss, R. Blockchain technology: An overview. IEEE Potentials 2022, 41, 6–12. [Google Scholar] [CrossRef]
. Lu Z, Su J. Clinical data management: Current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials. 2010;2:93–105. [Google Scholar]
3. CFR - Code of Federal Regulations Title 21 [Internet] Maryland: Food and Drug Administration. [Updated 2010 Apr 4; Cited 2011 Mar 1]. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=11.10 .
Student name : S. Neelofar
Student Id:1 113/062023
Qualification: Pharm. D
E-Mail ID: nelofor22@gmail.com
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