12 Jan 2021 Morgan Hayze
Clintex – Where Clinical Trials Data Meets Blockchain Technology And DLT
Over the past year, one of the worst pandemic crises in modern times has completely changed our lives and left a major impact on the global economy. The COVID-19 battle has initiated numerous clinical trials in a bid of developing working vaccines against the virus that will receive international approval from healthcare authorities and organizations.
Receiving approval from healthcare bodies, however, is a cumbersome process, that often requires large quantity of data to be processed for each of the drug approval phases. Despite that tests are taking place in an advanced modern economy, clinical trials data is still passed at a very slow rate.
Drug Testing Procedure
Drug testing often requires four stages of clinical trials before receiving approval from regulatory authorities. The first stage is conducted with a small number of trial participants, which varies between 20 and 100. As the research group increases the dosage, scientists are evaluating all side effects and the way the human absorbs, metabolizes, and excretes the drug. In the second stage of testing, drug companies conduct “blind tests” where one group receives the drug, while the “control” group is given a placebo. Phase 3 further increases the number of tested individuals with randomized and blind testing. If a drug successfully passes Phase III clinical trials, which often lasts at least a couple of years, a drug company is eligible to request approval from the corresponding drug safety authority for selling and marketing the drug.
The last stage, dubbed Post Marketing Surveillance Trials, consists of a comparison of the drug to other alternatives, monitoring long-term effectiveness and effects, and the costs associated with the drug therapy, compared to newer drugs or their alternatives.
The full 4-stage cycle of clinical trials could last between two and four years in total. Trials are not only time-consuming but very expensive too, as estimate figures show $30-$70 million in costs just for running a Phase III clinical trial procedure. Adding the previous two stages and the manufacturing process costs, an additional $2,5 billion on average is incurred for bringing a drug to the market. According to data from Wong et al., almost half of the costs for developing a drug comes from the Phase IV long-term surveillance trials.
The ClinTex Approach – Bringing Drug Costs Down Via Blockchain Technology
A large portion of the expenses associated with drug development comes from “data-driven” aspects, such as data acquisition, data management and analysis, and recruitment. Those data blocks can be easily transferred onto a distributed ledger, which grants fast, secure, and tamper-proof access to clinical trial data.
Over the past 20 years, the number of clinical trials has exploded, reaching 362,558 as of 30th December 2020. A 1% cost reduction across all clinical trials would result in billions of dollars saved.
ClinTex is a pioneer in developing blockchain applications for good – bringing affordable medicines to the people that need them faster and cheaper through optimization of the medicine’s development and testing processes, and with the use of smart contracts and distributed ledger (DLT).
The team at ClinTex shares 50 years of clinical experience, which helped the team establish major connections to the world of Big Pharma drug companies and clinical trials laboratories.
After a successful Tier 1 pre-sale, the company showcased the demand for a proven blockchain-based clinical trials data-sharing platform. Boosting demand even further, ClinTex partnered with leading crypto exchange KuCoin to bring clinical trials to the crypto trading ecosystem.
ClinTex’s Clinical Trial Intelligence Platform
Some of the benefits that ClinTex Clinical Trials Intelligence has over other clinical trials tools include bringing machine learning to clinical trial management, enabling full auditing functionalities, and eliminating the need for clients to cover hardware costs. The benefits also include a pay-per use model for ClinTex clients, powerful data analytics across various functions in clinical trials, creating a blockchain ecosystem based on collaboration across the pharmaceutical industry, and establishing ClinTex as the first collaborative platform for clinical trials.
ClinTex’s Clinical Trial Intelligence (CTi) blockchain-based platform is the first of its kind solution for clinical trial data processing, enabling smart contracts for end-to-end interoperability for pharmaceutical companies. The interoperability means the costs for data intermediaries would be significantly reduced, effectively pushing down the costs per product.
One of the main issues with clinical trials is the “FDA 21 CFR Part 11” regulation, which state that access to clinical data must be strictly authorized via a unique access key. ClinTex’s Clinical Trial Intelligence (CTi) blockchain-based platform utilizes the power of smart contracts and blockchain technology, and grants users a secure, traceable authorization, which ensures great flexibility and time-stamped, tamper-proof access to clinical data.
Various medical outlets pointed out the need for access to a blockchain-based clinical data management platform in a number of research papers. ClinTex is providing distributed, disintermediated, immutable storage of clinical information. The research papers emphasize the need for an auditable, transparent, secure, and trustless platform to mitigate the risks of patients` data leakage. ClinTex’s Clinical Trial Intelligence platform offers all of the above, adding several other tools to help out pharmaceutical companies to acquire data, insights, and visualizations.
The CTi platform consists of seven application tools, which target the main problematic areas in clinical trials:
- The CTi Operational Excellence (OEM) application grants users with provision of data-driven insights into waste reduction in clinical trials.
- The Predictive Analytics (PDA) tool uses historical data, combined with machine learning, to predict future problems before they even arise.
- The Site Investigators (SIM) tool helps recruit medics for conducting clinical trials and payment management.
- A patient recruitment and retention application, dubbed PRR, for monitoring patient activity and recruiting new patients for different phases of the clinical trials.
- The Vendor Management (VMM) application, which ensures the quality of clinical trials data by labs and third parties.
- The Risk-based Monitoring (RBM) tool that ensures effective resource deployments for areas in higher risk.
- Clinical Data Visualization (CDV) tool to provide users with visual analytics for a hassle-free decision-making process.
The CTi Token – The Heart Of The ClinTex Clinical Trials Blockchain
At the core of the CTi platform lies the native CTi token – a gateway for entering the platform. It is an ERC-20 Ethereum-based token, which acts both as a verification tool and a payment medium. All smart contracts are also running on the Ethereum’s blockchain, while a partnership with ChainLink will allow CTi token to utilize oracles for the facilitation of payments that occur outside of CTi’s blockchain. For example, ChainLink’s oracle services will help payments to investigators and vendors for their data attribution to be processed. The smart contracts have been audited by BEOSIN, with a detailed report consisting of 27 checks in 13 categories, which all have passed the rigorous auditing.
The CTi token also has another main feature – a staking model, which locks a certain number of tokens and effectively removes them from circulation. The staking would create a scarcity effect on the CTI token, which would be a further benefit for investors and CTi token holders. If ClinTex relied on the traditional, license-based model, the cost for the data licensing, transferring and drug research would be covered by the end customers, which is in contrast with the company’s main mission – to reduce the costs of medicines by reducing clinical trials costs. ClinTex estimated that by 2024, approximately 28 percent of the entire circulating supply would be locked for a minimum of 12 months, driving CTi prices up.
Also, the CTi token would be used as an access level verification tool, as the balance of CTi tokens will determine the parts of the Clinical Trials Intelligence platform users have access to.
CTi token meets the world of crypto exchanges
One of the largest and most well-known crypto exchanges to date, KuCoin, has announced that the CTi token is already live for trading on their exchange platform. For now, the supported trading pairs are CTI/USDT and CTI/ETH, which means Ethereum and Tether owners may enter the CTI trading right away. The project was initially set to be publicly launched in the form of an initial exchange offering, but the pre-sale success оf quickly reaching the soft cap and the opportunity to work towards the greater good of people led to a direct listing announcement on KuCoin. Purchasing CTi tokens supports ClinTex mission to bring optimizations and savings in drug research and development that will benefit eveyrone in need of better and cheaper medicines.
In conclusion
The world of clinical trials has been working in a slow, cost-ineffective way for decades. ClinTex aims to disrupt the current market state by providing a transparent, safe, and tamper-proof way of sharing clinical trial data, insights, and patient history. This way the overall cost of clinical trials and the time for medicines development will be dramatically reduced.
The opportunity is huge, as this is a $1.25 trillion industry that needs to be disrupted, and just one percent average cost reduction would generate a saving of $3.5 billion across the industry.
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