Introducing The Clintex Clinical Trials Intelligence (CTi) Platform:
The perfect application of a permissioned blockchain-based software solution.
In this inaugural post to our Medium channel, we’d like to give a very brief overview of the Clintex CTi Platform. We hope it inspires you to read our whitepaper, which obviously explains the project in much greater detail.
First some essential background:
The Clinical Trials Industry: Huge and Inefficient
Pharmaceutical companies conduct clinical trials in order to determine the safety and efficacy of drugs and other medical treatments. The trials form an integral part of the development of treatments. This is a multi-billion dollar industry and it’s growing in both size and cost. The number of clinical trials increased seven fold from 2004 to 2013, with the average cost for each of the four phases required for a trial now running at $15 million.
And while the number of clinical trials has increased, the relative number of approved drugs has simultaneously decreased. A 2012 study showed that the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950. It now costs around a billion dollars from start to finish to have a drug approved. That’s over 80 times as much as the cost to have a drug approved in 1950 (even after adjusting for inflation).
Meanwhile, profits earned from approved drugs have been on a steady decline. In the mid-90s an approved drug could be expected to bring in as much as $7 billion over its lifetime. Now that number is down to less than $3 billion.
All of this adds up to a lot of pressure on pharma-companies to streamline their operations and improve the success rate of clinical trials, which now runs at less than 10% overall.
Failed clinical trials and inefficient use of R&D money, while certainly detrimental to the bottom line for big-pharma, ultimately has the greatest impact on the cost of healthcare and ultimately on the quality of human life. Delays in the development of drugs to alleviate chronic conditions and acute illnesses mean pain and suffering for people, and spiraling healthcare costs for governments, payors and private patients. Healthcare spending in OECD countries has been rising steadily, consuming ever larger and larger a portion of national budgets. In the US it stood at just under 18% of GDP in 2016 and is projected to grow faster than GDP over the next decade, leading to warnings that with an ageing demographic, rising costs could result in the bankrupting of entire nations.
Reducing research costs and improving results is an industry-wide challenge but with clinical trials forming an integral part of the research process and accounting for a huge portion of the costs, any solution that focuses specifically on them has massive potential. Clintex Head of Clinical Data Analytics Neill Barron, with over 20 years’ broad clinical trials and new medicines development experience, knows the challenges and opportunities in the industry:
“Twenty years ago when I started in clinical trials, almost everything was paper-based data collection. Today, there are multiple sources of electronic data in clinical trials including electronic data capture, wearable technologies, lab data etc. However, the clinical trial industry has never truly capitalised on the full potential of this electronic data and still more or less works using manual paper-type processes rather than embracing the big data revolution.”
Other industry insiders like Definiens Chief Medical Officer Ralf Huss have for years been calling for big pharma to more effectively utilize data analytics and improve collaboration: “Big Data can make R&D and the clinical trial process much more efficient and effective,” he wrote in a 2016 column for industry magazine Clinical Leader.
While it’s clear that modern data analytics could help big-pharma reduce costs and speed up delivery of new and needed medicines, the fact is they are unable to fully utilize the data generated in their clinical trials because it remains fragmented and inaccessible.
FDA and other regulatory bodies’ rules make the safe and secure acquisition and analysis of clinical data essential. Combined with that, big-pharma is reluctant to aggregate their data and collaborate with rivals for fear of losing their intellectual property. And even if they could be assured of not violating patient privacy while protecting corporate IP, there’s still no good way to collaborate because there isn’t an agreed upon shared platform.
Blockchain Technology Opens The Door
Until now there has been no way to address this conundrum. Now however, Distributed Ledger Technology (DLT or “Blockchain”) will enable big-pharma to benefit from data analytics because:
1. Blockchain protects private data.
A fundamental tenet of blockchain — which is enabled by the concept in cryptography known as the “zero-knowledge proof” — is that one party can prove the validity of information to another without actually conveying the essence of any of the information. This is critical in the context of clinical trials because it means that sensitive patient information can remain anonymous while the data itself can be shared and fully utilized.
2. Blockchain ensures information security.
Big-pharma has been extremely reluctant to pool sensitive data and have it accessible online because of the risk of the information being accessed by unauthorized parties or being hacked. Blockchain offers the perfect solution: firstly, data stored in a blockchain environment is distributed in encrypted form across a network of nodes, meaning that — unlike data stored in a centralized database — it’s virtually impossible to hack. According to FDA regulations, access to clinical data must be limited to authorised individuals and each user must have a unique access key. Here again, blockchain offers the perfect solution: to retrieve data there are two encryption elements — a private key and a public address. The public address makes the existence of the record visible. The private key meanwhile reveals the contents within the record to the key holder. This basic formula creates great flexibility for controlling access to records and the data they represent.
3. Blockchain ensures the validity and immutability of data.
Because data stored in a blockchain is agreed upon through consensus across the network at a specific timestamp, it becomes effectively impossible to alter it once it is entered. This feature creates records that can be relied upon as never having been fraudulently altered; a critical feature for data that is used to develop medicines.
In summary, blockchain offers a secure, confidential and incorruptible way to share clinical data and clinical analytics across traditional organisational barriers during clinical trials.
ClinTex CTi Fills The Room
Now that it’s possible — thanks to blockchain — to aggregate and share the data, we are finally able to run effective data analytics.
Here’s where ClinTex comes in: we are building the platform on which the data can be aggregated and shared among stakeholders AND we are building the tools to allow that data to be processed, visualized, and acted upon.
Clintex CTi offers a complete software package that allows pharma to visualize the trial as it is being conducted. This will enable the researchers to determine exactly what needs to be improved or changed with the trial in real-time. For the first time they will be able to predict the probability of key events that impact the ability of a clinical trial to deliver the clinical data that regulators accept as proof of efficacy and safety of the drug being tested. For example, the data analytics provided by our software can identify patients who are statistically likely to drop out of the trial. The software will then show the likely cause of the problem and suggest the most effective solution. Carrying out this function automatically and effectively has the potential to translate into huge financial savings for pharmaceutical companies and significant reductions in the time it takes to develop treatments enabling them to bring proven effective drugs to the market more quickly. The outcome will be more affordable medicines available in a more timely fashion to the patients who need them.
The ClinTex CTi package also makes it easier to carry out critical clinical trial functions like sourcing and recruiting clinical trial volunteers, recruiting investigators to conduct the trial, and employing vendors to complete routine services from bloodwork to janitorial. ClinTex CTi does that by providing — for the first time — the space in which all stakeholders can gather to collaborate.
Finally, because ClinTex is powering its pay-per-licence software with a cryptocurrency, it is now possible to pay involved parties seamlessly, no matter their physical location. Not only that, but thanks to smart contract functionality, our platform enables payments to be completed automatically when previously agreed upon benchmarks and milestones are triggered.
First Mover Advantage
The Clintex CTi platform and data analytics software package is the first to offer such a comprehensive solution to the clinical trials industry. The development of our solution was the direct result of our core team members’ frustrations after decades of seeing firsthand the pain points in the industry. We know our solution is desperately needed and we are confident it will be adopted.
Watch This Space
In future posts we’ll go into more detail about each of the components of the ClinTex CTi Platform. We’ll also use this space to present pharma and blockchain industry news that has a direct impact on our project. Finally, we encourage you to follow this space for announcements about our business and software development progress, partnerships, and our upcoming token sale details.
In the meantime we encourage you to join our community channel in Telegram, where you’ll also have the opportunity to interact with our project: https://t.me/ClinTexCTi