Industry Experts Urge Pharma to go Blockchain

Cited vision and use-cases perfectly align with the ClinTex CTi platform

A paper entitled “How Blockchain Can Transform the Pharmaceutical and Healthcare Industries” has been published by England based pharma-tech think tank PhUSE.

The paper goes into a high-level examination of the feasibility of using blockchain technology in the pharmaceutical and healthcare industries noting that, “blockchain is a disruptive technology …and a cultural movement that our industries would be wise to embrace.”

Started in 2004 as the “Pharmaceutical Users Software Exchange,” PhUSE has grown to become a respected industry brain trust with an international membership of more than 8,500 clinical data scientists, many of whom attend the organization’s annual conferences in Europe and the US.

The researchers behind the paper cited a “confluence of factors” for why blockchain is suited to the pharmaceutical and health industries, including:

• Blockchain’s unique ability to effectively negotiate the tension between patient data privacy and data sharing;
• The inherent capability of blockchain tech to improve trust, transparency, auditability, and security of transactions.

This is of particular concern in the current pharmacological research environment because of:

• Increasingly strict regulations for industry interoperability and accountability;
• The cross jurisdictional nature of the pharmaceutical and healthcare industries;
• Unsustainable industry wastage, fraud, and mounting costs;
• Inefficiencies of the legacy R&D process.

The researchers concluded that blockchain technology is very well suited to improve clinical trial research, stating that with its implementation “… a drug can potentially be available 3–5 years sooner than with a traditional drug development process.”

Cutting 3–5 years in drug development time translates into billions saved by the pharmaceutical industry for just a single high-value treatment, not to mention the added years-to-life for those who rely on that treatment. Estimations for the potential value of cutting treatment development times are explored in this article: “The True Cost of Clinical Trial Failure.”

The PhUSE paper qualifies its optimism for the potential of the emerging technology saying, “blockchain still needs enterprise systems and APIs to enable end-to-end solutions.”

The ClinTex Clinical Trial Intelligence platform, as an enterprise software solution that leverages the advantages of blockchain technology, is exactly what the PhUSE paper is calling for in this regard.

Here’s a rundown of the specific reasons cited in the PhUSE paper for why blockchain has such transformative potential in clinical trials research and how the ClinTex CTi platform proposes to meet and even exceed that potential:

Data Integrity and Auditability

The PhUSE paper states that blockchain can enhance the data integrity of clinical trials by providing a full audit trail of each record (raw data), enabling seamless mapping into industry standards, and removing the need for manual quality checks. This improved data transparency for patients, healthcare practitioners, and regulatory authorities should add up to the enablement of faster submission for drug application, concludes the PhUSE paper.

Regulatory Compliance

Regulatory compliance, which is very much connected to data integrity and auditability, is also highlighted in the PhUSE paper as being enhanced by blockchain. Increasingly stringent data privacy regulations such as GDPR as well as compliance with the US FDA’s DSCSA (Drug Supply Chain Security Act), the Drug Quality Supply Act in the US, and the Falsified Medicine Directive in the EU are all simplified by the move to blockchain, according to the paper.

Collaboration

The PhUSE paper goes on to state that blockchain provides a “mechanism for real-time, secure, transparent, and auditable collaboration in clinical research amongst a group of peers,” and quotes Maria Palombini from the Institute of Electrical and Electronics Engineers Standards Association (IEEE-SA) who says, “an alluring feature of blockchain is the ability to negotiate the tension between patient data privacy and sharing.”

The ClinTex CTi Solution

Data Analytics Drive Research Quality and Efficiency

Data integrity, auditability, and collaboration are also the features of blockchain technology that form the backbone of the ClinTex CTi vision, which states: “Linking all clinical trial sponsors together on a common platform provides greater visibility across the end-to-end trial process. Enabling real-time access to information, and the ability to share knowledge more easily will foster greater collaboration.”

The ClinTex CTi platform thus enables the delivery of inter-company collaboration across clinical trials through the creation of a clinical trial datahub populated from the key clinical trial source systems.

The ClinTex CTi platform then takes that collaboration-friendly datahub populated by auditible data and applies advanced data analytics and machine learning to it in order to derive insightful actions that further drive efficiency and quality in clinical research. In other words, ClinTex CTi not only enables secure collaboration, it also provides valuable data analytics tools that can improve quality and efficiency in clinical trial research.

In the ClinTex CTi platform, three applications combine to do this. These three applications are the Clinical Data Visualisation Application, the Predictive Data Analytics Application, and the The Risk Based Monitoring Application. These applications work together to improve identification and sharing of issues that may impact on trial integrity and safety of patients. For example, the Predictive Data Analytics Application can take information from the Clinical Data Visualisation Application such as bloodwork, disease status, medication and adverse drug reactions to predict, for example, which patients are likely to have to withdraw from a trial. The Risk Based Monitoring Application may then recommend specific intervention to prevent the withdrawal of a particular patient, potentially saving the trial from complete failure.

Patient Recruitment

The PhUSE paper highlights patient recruitment as being particularly fit for blockchain disruption, even laying out a detailed use-case that aligns closely with ClinTex’s Patient Recruitment & Retention Application.

It takes on average 14 years to bring a new drug to market (at a cost of over 1 billion USD) and with at least a third of the total clinical trial duration taken up by patient recruitment, according to 2017 research. Such timeframes and costs have not improved in over a decade.

The PhUSE paper’s proposed use case to address this problem supposes that if a patient is interested in participating in a clinical trial, he or she could contribute a set of electronic health records adhering to Fast Healthcare Interoperability Resources (FHIR) standards by having data like demography and patient disease history anonymized through the blockchain. This would allow researchers to easily access the information in order to quickly verify the inclusion or exclusion of the patient from the trial. The paper states, “In the best possible case, the recruitment for a given trial could be completed in the space of one day with a substantial amount of the data already collected, allowing the clinical trial to begin on Day 1 or Day 2.”

The paper admits however, that such a use-case would involve the widespread adoption of regulatory compliant electronic health records, something that is still only on the fairly distant horizon for all but a few of the most tech-forward nations. However, the paper maintains that blockchain provides a “mechanism for secure, efficient, and transparent recruitment of subjects for clinical trials, with ability to digitally streamline the process.”

The ClinTex CTi Solution

Understanding that widespread adoption and integration of electronic health records remains distant, ClinTex’s Patient Recruitment & Retention application takes a more realistic approach than the “ideal” use-case outlined in the PhUSE paper. ClinTex’ solution is designed to kick start the leveraging of blockchain. The Patient Recruitment & Retention application therefore:

• Provides a portal for clinical research sites to share patient profiles relevant to participation in a clinical trial;
• Enables patients to express interest in participating in a clinical trial;
• Enables pharmaceutical companies to search patient profiles so that suitable patients can be identified for their clinical trial.

Vendor Management

Third-party vendors collect and manage data during clinical trials including pharmacokinetic/pharmacodynamic, serology, stool and blood analysis, electronic diaries, and ECG data. They provide different types of services based on the specific therapeutic area being trialled. For example, serology data is important for vaccine trials. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third-party vendors on a regular basis before, during and after the completion of the contract. Such processes often contribute to delays and constitute a significant portion of overall clinical trial costs.

The PhUSE paper highlights blockchain technology’s ability to enable “oversight of vendor and third parties’ deliverables in clinical trial/research with nearly real-time data, thus establishing robust processes quickly and efficiently.”

The ClinTex CTi Solution

The advantage of blockchain tech to manage vendors as highlighted by PhUSE corresponds closely to the ClinTex Vendor Management application, which plays a significant role in effective management of third-party vendor data. The ClinTex Vendor Management application provides oversight on data quality from third-party vendors. It also manages compensation by the pharmaceutical company to the third-party vendors (in the form of payment through cryptographically secured tokens), triggered automatically by milestones and KPIs such as number of assessments performed, data quality and data timeliness.

Huge Potential for Improvement

Nothing is static in technology. In clinical research for instance there is a growing trend towards remotely conducted trials in which participants are spread out over a large area, perhaps even across multiple countries. This trend is spurred by the increasing prevalence of IoT enabled wearables, but it remains largely out of reach because of current limitations such as a lack of ability to collaborate. For such a system to work effectively, more than ever there needs to be data security, the ability to safely monitor data in real-time, as well as collaboration across varied data sets and between multiple vendors.

The PhUSE paper states that “the evolution of traditional site-based trials to remote or virtual trials…can greatly benefit from blockchain for patient eligibility, consent, distribution of investigational drugs, and remote assessments to meet regulatory requirement.”

ClinTex is well positioned to capitalize on the trend towards remote trials because the ClinTex CTi array of connected application puts all the necessary pieces together to more effectively run a clinical trial.

The PhUSE paper’s projection that the integration of a blockchain enhanced ecosystem to medical trials research has the potential to bring treatments 3–5 years sooner than with a traditional drug development process is, we believe, optimistic in the short-term but realistic in the long-term.

But considering even just a 1% average cost reduction across all trials running today would generate a saving of $3.5 billion across the industry (based on a rough estimation of the total cost of all trials globally) the potential to improve clinical trial research, reduce costs, and improve treatments appears vast and very much supported by emerging innovative technologies, particularly the blockchain technology that is the foundation of the ClinTex platform.