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A Trust-Centric Healthcare Journey Part II: Challenges Found in Clinical Trials and Health Data

In order to fully grasp the work that PharmaLedger is doing to transform clinical trials and patient health data, we must first understand the challenges faced within these domains.

The COVID pandemic made it clear that the healthcare system wasn’t ready to support the solutions our society needed. PharmaLedger is excited to be actively working on this as the project’s use cases are correlated to the healthcare challenges and the pandemic’s effect. We believe that our solutions build a new culture of sharing data in healthcare, which are all crucial for helping to ease the burden of the pandemic’s impact. 

PharmaLedger started in January 2020 and is a three-year project that is funded by the Innovative Medicines Initiative (IMI), and sponsored by the European Union and the European Federation of Pharmaceutical Industries and Associations (efpia). If you are new to the project you can read more about how we got started, check our intro into PharmaLadger below.

PharmaLedger has eight use cases, four of which fall under Supply Chains, two in Clinical Trials and two in Health Data. In order to understand the approach PharmaLedger is taking, it is important to know the challenges faced in the current state of these domains. You can read the challenges faced by healthcare supply chains and rewatch our first open webinar: “A Trust-Centric Healthcare Journey Part I” to find out more about this domain. 

We recently hosted our second open webinar “A Trust-Centric Healthcare Journey Part II: Clinical Trial & Health Data Use Cases,” which you can rewatch on our Youtube channel in case you missed it.  This article aims to introduce the challenges faced by the four use cases falling under clinical trials and health data, and you’ll gain a better understanding of why they were created. With this introduction, you’ll be able to better understand PharmaLedger’s future vision and the added value it brings.

#1 Clinical Trial: eRecruitment Use Case

Clinical trials are a crucial part of the health system. Research is conducted to reach new medical knowledge and to test whether treatments are safe and efficient. Clinical trials can range from a dozen or so to a thousand participants and there are multiple independent bodies that make sure that the participants stay safe. When clinical trial recruitment occurs, doctors explain the study, the benefits and the risks to a patient at a clinical site. Each trial has strict criteria, which can be filled by voluntary participants. It isn’t easy to find participants and the recruitment process poses many challenges.

The current clinical trial recruitment process is not patient-friendly and it’s inefficient. A patient can submit his or her medical record for one trial, then resubmit the same information for another trial until he or she finds the perfect fit. It can seem quite discouraging and it can be a lengthy process.

The PharmaLedger eRecruitment use case aims to bring patient-centric recruitment with patients finding the studies themselves. Digitising the application process and having the patient submit his or her health data once with the help of blockchain technology are just some of the points this use case aims to do. You can find out more information and the added value the eRecruitment use case can bring by viewing the video from our webinar recording below!

#2 Clinical Trial eConsent Use Case

After a participant is approached for a clinical trial, an informed consent form must be obtained. After the consent form is signed, the participant is screened for eligibility in the study and his or her health data is collected and evaluated. The informed consent and risk processes is a manual and often tedious process. These processes are often inadequate to ensure the clinical trials quality, inaccurate or incomplete almost half of the time. This is often related to the clinical trial protocol – the instruction manual on how to actually conduct the clinical trials.

Informed consent is a crucial part of the clinical trial process. A trial cannot continue without it being obtained from patients, and it is impossible to conduct the study without participants. The current state of informed consent provides the patient with any needed information about the study, risks and benefits. Some pain points include that it is a complex process, the data is siloed and it can be quite confusing. There is also a lack of transparency with high non-compliance risk at many touchpoints. It is quite inefficient since there isn’t a single platform for this process.

Blockchain technology can help with informed consent by adding immutability, automation, trust and real-time updates. PharmaLedger plans to use this technology in its eConsent use case, which you can learn all about in terms of the future state and the added value by watching the eConsent use case video from our recent webinar below.

#3 Health Data IoT Medical Device Use Case

IoT medical devices, such as patches, phone applications and sensors, are creating silos and many other challenges. These applications are often disconnected from each other since they use their own cloud or applications for data storage. The data cannot easily be accessed and used for studies, since it would have to be downloaded weekly or monthly to process to be used in clinical trials or by researchers. This time-consuming process is inefficient and the various devices that one patient might use create a disconnected ecosystem.

Another issue at hand is safety and regulation, so providing some sort of cybersecurity mechanism would be ideal. There isn’t a single common platform that could read the data of these various devices. There is also a lacking standardization in data formats as more and more companies create their own, and the siloed information of these devices do not have traceable and verifiable data. There is evident disconnection and time-delay between the information gathered and what can be used for research. Currently, there is no smart analytics to process this data to be able to make quick decisions for a patient’s health.

PharmaLedger’s IoT Medical Device use case aims to make use of blockchain properties and interoperability to connect the data of these devices on the PharmaLedger platform in order to have patients safely and more-easily participate in clinical trials or non-interventional clinical trials. You can find out about PharmaLedger’s solution to overcoming the challenges mentioned, its supporting study within this use case and the value it brings by rewatching the IoT Medical Device use case video from our webinar!

#4 Health Data Personalised Medicine Use Case

Currently, patients don’t have much control nor knowledge of their own personal health data and what is recorded. If a patient wants to somehow retrieve data, he or she most likely has to go on a research hunt through hospitals with no guarantee of success. If there were a way to create real-work data space and combine health data from other patients based on prediction models and data privacy, there could be a better solution for determining patient health risk and the best possible treatments. This is exactly what PharmaLedger’s Personalised Medicine use case aims to do.

By using blockchain technology, this use case aims to support patient-centric solutions in a trusted environment. Researchers would be able to use real-world evidence to come to better diagnosis prevention and personalised treatment. You can find out all about the proposed solution for the Personalised Medicine use case, why blockchain technology is the perfect fit and the added value to the stakeholders involved in our recent webinar: “A Trust-Centric Healthcare Journey Part II: Clinical Trial & Health Data Use Cases.”


If you haven’t had a chance to participate in our recent webinar, you can rewatch it on our Youtube channel and look forward to individual use case articles that breakdown the video content with included timestamps. Make sure to subscribe to our Youtube channel to get notified right away to when we will upload each individual use case presentation from clinical trials and health data. You can look forward to these videos in the next few weeks!

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