Featured Article: Clinical Research News – PharmaLedger Project To Create Blockchain-Based Clinical Trial Solution

Some of PharmaLedger’s use cases are discussed in a featured article from Clinical Research News.

Clinical Research News offers the latest updates in the life science industry, as well news on emerging technologies in clinical trials. Their article, “PharmaLedger Project To Create Blockchain-Based Clinical Trial Solution,” written by Senior Science Writer Deborah Borfitz (Cambridge Healthtech Institute) features our project and how we working on new solutions within the clinical trial sector. 

In the article, Baldwin Mak (Boehringer Ingelheim), who spoke at the Scope – Summit for Clinical Ops Executives event in early February 2022 also shared current problems in clinical trial conduct and how PharmaLedger is hoping to evolve and improve these processes with the help of blockchain and a few of our use cases.

Clinical Trials: Starts with Informed Consent

The article starts by highlighting how manual, paper-based consent documents for trials often lead to delays and negative outcomes for trial processes. Participants of these trials must be informed of many details about the study through these consent documents. “Any deviation from the consent document can negatively impact patients as well as the study itself,” Mak explained.

If changes are made, participants must be informed, which many times may lead to problems due to the lengthy process.

Blockchain in Clinical Trials

Our PharmaLedger project is then introduced, along with our end-to-end conduct for clinical trials with the help of blockchain. This technology can help adhere to any changes in the consent and support patient rights and safety. Another benefit of this technology is that it can provide a trusted source of information since recorded data can’t be altered (it is immutable). This is especially useful in clinical trial settings when it comes to screening, analysing or collecting samples.

Through electronic consent (eConsent), part of one of PharmaLedger’s use cases, patients can be re-consented electronically for any updates or changes made. Smart contracts can also empower patients to grant access to their sensitive data more easily. This automation of what is now complex with paper documents leads to more efficient clinical trial conduct. 

Blockchain can also create greater transparency, security and trust not only for patients, but all stakeholders involved in the clinical trial ecosystem — sites, sponsors, labs, ethics committees, and health authorities.

PharmaLedger Use Cases Adjustments

Mak goes on to explain that in its beginning, the PharmaLedger eConsent use case aimed to create a “digital solution that leverages the status of informed consent on the blockchain for study visits and data collection and use.” As time passed, however, and planning for the pilot began, many adjustments have been made, as eConsent builds upon and overlaps with PharmaLedger’s IoT and Personalised Medicine use cases. The adaptation to the original goals and solutions of these use cases are still in progress, as new problems and answers arise throughout the project’s advancement. More information about the evolution of these use cases will be released later on this year.

Improved Efficiency in Clinical Trails

Not only is the patient more aware of the clinical trials conduct and empowered to share their data, but the trials can become more efficient and proceed with less resistance. Sponsors can gain improved data quality and lower costs for trials, while labs can gain compliance for trial management (such as halting assessment for an errored sample collection). 

As stated earlier, many of the stakeholders can benefit from using blockchain technology in clinical trials, but there are still barriers to adopting this technology. PharmaLedger is working on other use cases as well, to help overcome technical issues and showcase tangible solutions for helping to embed blockchain in the healthcare industry and create a digitally trusted ecosystem.

We would like to invite you to our next webinar, “Building a Digital Trust Ecosystem – Blockchain & OpenDSU” which will go further into detail about the technical aspects behind PharmaLedger’s blockchain platform and the next phase of the project, – the Digital Trust Ecosystem (DTE). Make sure to sign up for our monthly newsletter below to be the first to register for this exciting event. 


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