DATA MANAGEMENT TECHNOLOGY &
Keeping track of every change, such as its content, people and time of modification – details that are trackable and could be crucial during the clinical trials. All the historical data will be created, made and kept trackable with multiple copies being stored, and shared in various predetermined stakeholders’ computers.
Allowing an exchange of data between laptops, smartphones, computers, servers, and internet-connected instruments and equipment, without having to reply on email or other unsecured methods. This flexibility in its database interoperability also allows the data to securely retain its integrity.
Given that patient recruitment and retention
is often a major hurdle for running clinical trials, patient recruitment is currently done by using hospitals, doctors, message boards, websites, advertisements and more to find candidates for the clinical trial. People can possess and manage their own health data on a blockchain, which contains everything – such as steps taken to track and assess patients’ health history. Equipped with secure and immutable health data in the hands of patients, they are now able to voluntarily share them at will. Patient recruiters could then help sponsors to efficiently identify and quickly select the fitting candidates for a clinical trial. Furthermore, with a patients’ health data
stored in a blockchain, it could not only allow that person control over data in accordance to privacy regulations, but also anonymous personal information for any secondary research use, time- stamp data transactions for audit trials and electronic health record (HER) integration with blockchain- backed transmissions. It is all about compiling data and using it for the greater good. In the presence of an immutable database with built-in trust, it is safe to apply deep data mining algorism combined with AI-infused data investigations to help clinical trials find the best sites, participants and protocols to help their trial succeed.
A combination of blockchain and AI By building a blockchain database architecture based on hyper-ledger, this allows AI and machine learning to be applied and farm the immutable database intelligently and reliably. This effectively utilises the power of modern computational power and internet connectivity to accurately farm and interpret stored trial data. This helps
58 | Outsourcing in Clinical Trials Handbook
the researchers to harness the clinical trial data with tremendous amount of efficiency, due to the database having been created and preserved with its utmost integrity. By first applying machine learning on the human intelligence obtained from past trials, historical clinical trial data, medical journals, regulations and best practices, the data is stored on the blockchain. Next, to further apply the algorism constructed to apply AI- based predictions for site investigations, patient recruitment and retention, risk-based monitoring, data visualisation and more in order to make best recommendations in real time, this will effectively reduce costs, time and setbacks during each phase of the trial. In short, the best way to unleash the power of blockchain technology is to integrate machine learning and AI, facilitating the clinical trials process to operate seamless and improve systematically.
“By building a blockchain database architecture based on hyper-ledger, this allows AI and machine learning to be applied and farm the immutable database intelligently and reliably.”
In summary, the clinical trial field needs a company that combines both blockchain technology and AI to not only store data, but to be able to accurately predict and address problems beforehand by using all relevant data available. Because of the centrally oriented data flow of existing clinical trials, it may make sense to first create an internal blockchain to replace the existing data flows already utilised by clinical trials. Most sponsors and stakeholders in a clinical trial don’t have the expertise and experience needed to create and maintain a blockchain, so they have to rely on external companies to not only create the blockchain for them, but also to manage it throughout the clinical trial to ensure the maximum benefit is reached. Ultimately, a perfectly fine-tuned hyper-ledger approach would include the implementations of blockchain, machine learning and AI together, in order to effectively analyse massive amounts of clinical trial data in real time and achieve hyper-efficiency for the trial. Eventually, billions of dollars will be saved and rewarded to the companies that are fast to adopt the above-mentioned database approach. ●
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