According to ClinicalTrials According to the data of gov website, the global drug development market is worth more than 350 billion US dollars every year, including the cost of research and the resources used.
In addition to money, these trials have many other problems to deal with: patient treatment, incomplete / unreliable data, and delays that usually delay trials by an average of nearly 11 months. Taken together, all these factors cost the company an average of $8 million a day because clinical trials were delayed.
The modern history of clinical trials dates back to 1747, so why didn’t we find a faster, more accurate and cheaper way to complete them?
More in-depth research
Clinical trials have many stages and can be better optimized in many different places. To understand the overall situation, let’s take a look at how standard clinical trials are conducted.
Phase I – duration: several months
This phase of a clinical trial assesses the safety of a drug and usually includes a small number of healthy volunteers whose participation is paid. The purpose of this phase is to ensure that the drug is safe to take and to measure how it is absorbed, metabolized and excreted. Side effects are often found at this stage, and about 70% of drugs pass this stage of research.
Main disadvantages: voluntary patient recruitment and retention, data management / analysis, and payment portal.
Phase II – duration: months – two years
Drugs that pass the first stage will be tested here. After all, if a drug doesn’t achieve the effect it should achieve, what’s the use of it? Phase II studies are usually randomized, with one group taking drugs and the other taking placebo. In addition, these studies were “blind”, so neither the participants nor the researchers knew who was taking the drug. About 33% of the drugs passed this stage of the study.
Main disadvantages: patient retention, data management / analysis, data integrity and human error
Phase III – duration: several years
On average, the most expensive and largest official testing phase, phase III, can include hundreds to thousands of patients, usually distributed around the world. This phase exists to help FDA better understand the effectiveness of drugs. Due to the large number of participants, the budget of this phase usually increases. So far, 70% to 90% of drugs can pass this stage.
Main disadvantages: data tracking and analysis, patient recruitment and retention, central laboratory management, investigator site management / integrity check and payment portal
Phase IV – duration: until completion
This stage occurs after the drug is on the market. It is usually necessary to monitor the long-term use of drugs and the impact of drugs on the quality of life of patients. At the end of the fourth phase, the drug can continue to be used or withdrawn from the market for re evaluation.
Main disadvantages: large amount of data tracking and reporting
Almost all drugs on the market have gone through these stages, which is why almost all clinical research can benefit from modern blockchain technology and solve many common problems and weaknesses experienced in clinical research. Considering the database functions as the core of the blockchain, it should not be surprising that when it comes to data tracking and management, they will surpass the existing systems in terms of efficiency and invariance. But this is not all the blockchain can provide to the clinical trial industry
Clinical trials on the chain
Many companies are trying to be the first to receive the huge reward of clinical trial funds, but most of them are using the same solution to solve this problem.
To sum up, clinical trials usually go through four stages and have many different weaknesses.
Blockchain can directly solve most of these problems, such as:
·Clinical data security: the ability to track each record and change across multiple devices.
·Immutable transaction ledger: FDA requires verifiable data, while blockchain ledger can provide immutable proof for records.
·Historical data: it is very important for clinical trials to be able to track every change, who did it and when. Blockchain can go further and store all these data in the same location.
·Interoperability: exchanging information between laptops, phones, computers, servers, etc. without relying on e-mail or other methods is critical to data integrity.
Here are four companies currently competing in this field. I briefly introduce their business and advantages.
Although the company is not directly involved in the clinical trial process, it is a strong supporter of tracking and managing health data.
Considering that patient recruitment and retention is a major weakness of clinical trials, patientory has a lot of opportunities to intervene and fill this gap. By helping people manage their health data on the blockchain, from tracking steps to heart test results, patientory can easily shift its focus to helping clinical trials find research participants. Often, research has to rely on doctors, message boards, recruitment websites, advertisements, etc. to find participants – clinics can completely eliminate this need by providing ideal candidates who are already using patient clinic services.
Guardtime has a long history of success in creating a proven secure blockchain. Guardtime health, a branch of the company, focuses on five key aspects: health data blockchain, personal privacy control over data, anonymous personal data for secondary research, timestamp data transactions for audit trials, and EHR (electronic health record) integrated with the transmission supported by blockchain.
Like patient, trials AI also compiles data and uses it for greater purposes. The focus of trying artificial intelligence is to inject artificial intelligence data investigation, help clinical trials find the best place, participants, and protocols, and finally help their trials succeed. AI allows researchers to gain insight into past trials, medical journals, regulations and best practices to reduce costs and setbacks.
By combining many of the practices mentioned above, clintex IO uses a hybrid approach that combines AI, ML and blockchain to help researchers create and maintain a successful clinical trial. Build artificial intelligence based prediction, field investigation, patient recruitment and retention, risk-based monitoring, data visualization and other protocols, and clintex IO brings the real power of blockchain technology and artificial intelligence into clinical trials. Clintex’s two specific applications, CTI OEM and CTI PDA, help researchers save more money and time. The former (CTI OEM) provides AI driven insights into the high waste areas of clinical trials, while the latter (CTI PDA) uses historical clinical trial data to predict future performance and price issues.
Is there an ideal solution?
Although no company is perfect, the clinical trial field needs a company that combines blockchain technology and artificial intelligence, which can not only store data, but also use the data to detect problems and costs before problems arise. In order for clinical trials to benefit from these technologies and save money, they must migrate all existing technologies and methods currently used to the blockchain without any interruption. Since the data flow of existing clinical trials is centralized, it may be easier to replace the existing data flow already used by clinical trials with the service of creating internal blockchain.
Most researchers and companies that create clinical trials do not have the expertise and experience required to create and maintain blockchains, so they must rely on external companies to not only create blockchains for them, but also manage them to ensure maximum benefits. Relying on guardtime to create blockchains is a solution, but to get full benefits, you must rely on experimentation. Another option is to use clintex, which recently tested their software by integrating various test data provided by the European Medicines Agency. Clintex can provide operational insights for many advanced clinical trials, which is very helpful for their cases because they have market experience.
The winners will be those companies that can successfully integrate multiple clinical case studies into their systems first. They will have solid evidence that blockchain and AI can help reduce costs and errors.
As we can see, the efficiency of clinical trials will certainly be improved and the cost will certainly be reduced.
Blockchain will definitely play a huge role in this regard, especially when it is combined with machine learning algorithm to further analyze massive data. The world needs a better way to complete clinical trials safely and quickly, and companies that provide the best solutions can get billions of dollars in clinical research funds in the United States alone.
Responsible editor; zl