Clinical trials have been the bedrock of medical research since the post-war era. They are used to establish the safety and efficacy of medical treatments before treatments are made available to the public — but there’s a growing crisis in clinical trials: rising costs and increased lead time for medicines development increasingly hold back the introduction of important new treatments. The ClinTex CTi suite of block-chain enabled tools is being developed to solve the unique and complex problems facing the modern clinical trials process.
The rising cost of developing medicines
As medicine has advanced, conducting clinical trials for the development of new medicines has become an increasingly complex proposition. This State of the Industry report from leading research firm First Analysis, for instance, found that clinical trial complexity has increased by nearly 86% over the last ten years. And as the complexity of clinical trials has increased, the cost of conducting them has ballooned to unsustainable levels. The latest figure for the cost of developing a prescription drug that gets marketing approval is a colossal $2.558 billion, a number that has risen dramatically over the last two decades.
With one only one of every 10 drugs that starts trials getting approved by the FDA, and an average time-span of more than 10 years from concept to approval for a new treatment, return on pharmaceutical R&D investments is on the steady decline. Deloitte’s analysis of a cohort 12 large biopharma companies, for instance, showed a sustained decline in R&D return on investment from 10.1 percent in 2010 to 3.2 percent in 2017.
Is digitalization the answer?
Digitalization has long promised to reduce the costs and improve efficiencies of clinical trials management. So-called “eClinical” trials, are now touted as the next big thing in clinical trial management. Indeed, huge investments have been made into eClinical solutions over the last decade. The eClinical solutions market was valued in a 2019 report from industry analyst Mordor Solutions at USD 5.06 billion in 2018, with expected CAGR of 12.86% over the next five years for a 2024 value of over USD 10.5 billion.
In a nutshell, eClinical trials move much or all of the traditionally paper-driven clinical trial process to the digital milieu. At the most basic level, instead of reports being filled out by hand, they are filled out digitally either at desktops on or tablets. This, in theory, improves the capacity to share data amongst stakeholders in the trial, while also cutting down on costly human-error.
eClinical trials also attempt to ease some of the frictions in the clinical trial process by conducting them on mobile devices. For instance, rather than forcing a trial participant (patient) to make their way to a clinic to “self-report” during a trial, mobile applications can allow the patient to make such reports from the comfort of her home. This is important for improving patient retention in clinical trials. The quality of a trial depends in large part on the number of participants it monitors. With dropout rates now as high as 30% for traditional clinical trials, increasing patient retention in clinical trials has become a critical issue.
Finally, eClinical trials improve on traditional trials by integrating additional data that was previously impossible or very difficult to integrate. For example, trial participants can now be outfitted with biometric-tracking wearables that provide a much higher granularity of data, even while the patient is in the “real-world” as opposed to a strictly clinical environment.
For all of these reasons, digitalization promises to increase clinical trial efficiency, thereby reducing the cost and time needed to develop life-saving medical treatments.
Barriers to digitalization
Unfortunately, major barriers stand in the way of the digitalization process. At the heart of the problem is data security. Information collected in clinical trials must fulfill several important criteria:
1. It must protect the identity of participants.
2. It must be proven accurate and untampered.
3. It must be shared across only permissioned stakeholders such as vendors, regulators, and clinical research organizations (CROs).
From the perspective of the pharmaceutical companies spending millions to conduct the trials, it’s essential to maintain ownership of the data collected during them. Data collected in clinical trials is an asset that ultimately enables the creation of the intellectual property that pays for the R&D process. While digitalization certainly promises to increase efficiency of the clinical trials process (thereby lowering R&D costs), if electronic data falls into the wrong hands as it so often does in the digital era, the consequences can be disastrous from an IP-protection perspective. Secondly, data leaks are a regulatory nightmare from the perspective of pharmas and CROs, who could be fined heavily and even lose their license to conduct trials. These are just some of the reasons pharmas and CROs have been extremely slow to digitalize their clinical trials.
Now consider the perspective of regulators. They must somehow be assured that data collected during clinical trials is untampered. It’s effectively impossible to ensure as much with traditional database technology due to the relative ease which bad actors can change entries without other stakeholders’ knowledge.
Finally, consider the perspective of the entire clinical trials ecosystem. Remember, the goal here is to develop effective medical treatments safely and cost-effectively. For the true potential of digitalization to be unleashed, all permissioned stakeholders in the clinical trial process need an as-close-to-real-time-view as possible of the data collected. The problem is: how to provide that collaborative view while simultaneously protecting the data from hackers or other un-permissioned actors?
How blockchain overcomes the barriers to digitalization
Distributed ledger technology, blockchain – whatever you want to call it – can aid in the process of digitalization by overcoming the above-listed barriers. At a first principles level, it does this through decentralization and distribution of the database that contains clinical trials information. Transparent rules and protocols for the accessing of and writing to the database are agreed upon ahead of time by stakeholders, and there is no way to skirt the procedures. In practice, what this means is that all participants can be assured of the immutability of data once it has been entered into the shared database. This effectively solves the tamper problem described above.
Further, utilizing public-private cryptography, participants can be given granular read-write access to the database based on their permissions. This means, for example, that wearable devices can write to the database, but the wearer of device cannot read the database. Another example would be a vendor such as a food supplier during an in-situ clinical trial having the capacity to input data on foods served during the trial, but not having access to any other portion of the database. This solves the permission problem.
Finally, the database itself can be updated at very close to real-time, giving all permissioned participants the real-time view of the data they need. This solves the collaboration problem, unleashing a wide variety of potential improvements in the clinical trials process.
“Stringent regulation is placing ever increasing demands on trial data as data sources become more complex and varied. The use of predictive data analytics, and the interoperability of the use decentralised ledger technology, allows clinic trial sponsors not only to manage this complexity securely, but also to drive collaboration across pharma and develop data driven insights. As someone with 20 years’ experience working on large clinical trials, I’m excited by the impact blockchain and distributed ledger technology can have on medicines development.”
– Ethan Diamant, Director of Clinical Data Services, ClinTex
The ClinTex Solution
ClinTex’ clinical trial intelligenceplatform enables permissioned stakeholders to trust the data they are seeing. From the perspective of regulators, having assurance of the data’s security and a reliable view of the data collected is exactly what’s needed to protect trial participants and confidently approve effective medicines while rejecting clearly ineffective ones.
The ClinTex CTi suite of blockchain-enabled tools also enables participants to unleash the power of digitalization in medical trials. Two key features in this regard are the ability to:
- Visualize medical trials’ data in real-time.
- Glean insights into medical trials’ data as the trials are being conducted.
From the perspective researchers, this will make it possible to identify, for example, patients who are on the verge of dropping out of a trial. Having identified such at-risk patients, appropriate measures can be taken to intervene where necessary. Researchers will also have the data they need to, for example, cut-short trials that are showing inefficacy of the trialed medicine far sooner than was previously possible, thereby saving time and money for everyone involved.
Finally, the ClinTex CTi solution deploys the innovative use of “smart contracts” – contracts that automatically execute when agreed-upon conditions have been met. This allows CTi to cut out costly and slow intermediaries in the clinical trial process. For example, the secure execution of a payment to an investigator can be automatically triggered as pre-set milestones are reached, based on clinical data entered into CTi, and verified by an outside system through an oracle (as outlined in phase 2 of our roadmap). This works to further drive down costs in the delivery and research of new medicines.
“With CTi, ClinTex will lead the development of AI and blockchain based interoperable solutions tailored to specifically attack the key pain points in clinical trials. By doing so, CTi promises to provide huge cost savings in the development of new medicine, ultimately benefiting end-users, patients, and healthcare as a whole”
– Brendan Mannion, Co-Founder, ClinTex
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