1. PharmaLedger’s Clinical Trial eRecruitment Use Case

Kicking off 2021 and year two of the PharmaLedger project, we hosted our second Open Webinar “A Trust-Centric Healthcare Journey Part II,” on the 24th of February and the 3rd of March which covered the challenges, solutions and added value of our four use cases under the umbrella of clinical trials and health data. If you missed this webinar, you can now find the full recording, individual presentations, and topic-specific Q&A sessions from the event on our YouTube channel. 

Clinical Trial eRecruitment Use Case

The first use case covered in the webinar was Clinical Trial eRecruitment, presented by its co-leads: Despina Daliani (Onorach) and Ken Nessel (Pfizer). You can find the recording of this presentation below, along with the Q&A related to this topic asked by the participants at the end of the video:

Here is a brief overview of the presentation, with minute markers to help you navigate the video recording.

Introduction to Clinical Trials (0:55)

Clinical trials are a type of research where people can participate in a study that contributes to new medical knowledge. They allow new treatments to be developed, tested, and ensured for safety and effectiveness. 

Each clinical trial has a strict set of criteria for who can participate. Clinical trials must find people who want to voluntarily participate, while also meeting their criteria for inclusion. In general, this recruitment process has been historically challenging. 

Current Situation: Clinical Trial Recruitment (2:30)

The current process for clinical trial recruitment poses a significant challenge to clinical research.

As the situation stands, recruitment methods remain study-centric, meaning that clinical trials typically find participants through a Principal Investigator (Doctor), or through direct advertising. But through emerging trends and technologies such as an increase in patient-access to health data, tools to put this data to use, as well as the willingness to participate in research, we are moving toward a future where recruitment methods can be additionally patient-centric. Patient-centric recruitment would allow potential participants to discover the studies themselves, but in order to unlock this potential, trial pre-screening needs to be more accessible.

Challenges (4:49)

The image above represents an example of the current pre-screening process a patient might go through to be matched with a clinical trial. As you can see, the patient must first provide their health information to a trial Investigator at a clinical site, or through a study website, in order to even inquire about any relevant studies pertaining to them. This process can be repeated multiple times before the patient might find a match. This presents a multitude of pain points:

You can read more about the challenges faced within the domains of clinical trials in our previous article: A Trust-Centric Healthcare Journey Part II: Challenges Found in Clinical Trials and Health Data.

Future Vision (5:58)

PharmaLedger’s Clinical Trial eRecruitment use case aims to create a neutral, industry-wide utility to help patients or their healthcare providers, more efficiently find clinical trials which match their health profiles and interests.

Consider the image above which depicts an example of the PharmaLedger vision for electronic clinical trial recruitment. To begin, the first step for the patient remains to provide their health information. The difference here, is that this time the individual submits their information through a web application and only one single time. The patient then grants permission for their information to be run through an algorithm fed into a patient-matching utility, which contains pre-screening criteria for multiple different studies and sponsors. This system works to match the patient to any relevant studies, which they have access to view on a dashboard shown on their screen. 

The Patient-Empowerment Experience (8:05)

In the image below, you can take a look into what this process would actually look like through the eyes of a patient.

Why Blockchain for Clinical Trial Recruitment? (9:42)

Why Blockchain for clinical trial recruitment? It’s simple: the proposed patient-matching utility isn’t possible without trust.

• Patients will only share their data if they can trust the matching utility will protect their privacy and security.
• Sponsors will only share their trials if they trust the matching utility is fair and equitable.

Blockchain technology can give us the means to provide this level of trust, as operating this utility on a decentralised network can guarantee that no single party has undue influence. PharmaLedger plans to have the full provenance of a matching transaction anchored to a blockchain, ensuring the operation of the utility can be trusted by all parties.

Value Proposition to Stakeholders (10:30)

PharmaLedger’s proposed solution for Clinical Trial eRecruitment would bring immense value to all stakeholders involved. By simplifying the process by which patients can learn about potential studies and empowering them to have full control of their data, we believe we can encourage a higher rate of participation in clinical research. In turn, we can accelerate clinical trial recruitment, allowing sponsors, clinical research organisations, and clinical sites to reduce costs, simplify operations, and demonstrate patient-first imperatives. Lastly, PharmaLedger’s eRecruitment solution would allow physicians to stay up-to-date on clinical trials and better support their patients to find their best fit. 

Roadmap (11:30)

Below you can see our projected timeline in implementing PharmaLedger’s Clinical Trial eRecruitment solution. 

Poll Results (12:47)

During the Clinical Trial eRecruitment presentation, webinar attendees were asked to answer the following poll question: If you were interested in participating in clinical research, would you use the PharmaLedger matching utility to find relevant and appropriate clinical trials?

• Yes, sounds like a useful tool (74%)
• Maybe, could be useful but I’m not sure (22%)
• No, I would not use this utility (4%)

The vast majority (74%) of respondents agreed that the PharmaLedger patient-matching utility would be a useful tool.

Q&A (14:07)

At the end of the webinar, participants were asked to submit questions that were then answered by the presenters. You can find the questions asked below, and use the minute markers to hear the answers.

• Have you analysed Patient Matching Utilities relation to GDPR? Who would be the data controller? (14:15)
• How would you communicate that this utility is safe? the communication would be worldwide and not specifically targeted-would that be cost expensive? (16:13)
• Are there considerations about monetary incentives for patients providing data for clinical trials? (17:30)
• How would you guarantee that no excess information is given (or asked for) to a company that does not need these data for trials? (18:49)
• Will there be impact on inclusiveness if patients need to access an app to be included in trials if they don’t have a smartphone? Any solution for that? (21:02)
• Recruitment- how would governance work for such a matching tool? (23:05)
• Blockchain has been used without specificity. Which ‘blockchain’ platform? And how do you intend to scale the voluminous data processing and use? (24:38)
• Who/which suppliers would make these blockchains a reality? This is costly work and there are no off-the-shelf solutions. (27:10)
• Can you please describe the process for achieving agreement on the data governance by all consortiums for all/any of these studies? (28:15)
• How to join PharmaLedger ? We have developed an scalable use case that fits 100%. (30:06)
• When could patients expect solutions to be available? (31:58)
• Given that there are other similar solutions in development, how will you build the critical mass to ensure yours is successful? (33:28)
• Will Big Pharma own these solutions? (34:30)
• How many ledgers and nodes do you have on a possible chain code? (35:17)
  

Closing Remarks (37:03)

Over the next few weeks you can look forward to recap articles around each of the other three use cases covered in “A Trust-Centric Healthcare Journey Part II.” Next up, Clinical Trial eConsent!

You can watch the full recording of PharmaLedger’s recent webinar, “A Trust-Centric Healthcare Journey Part II” below.

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PharmaLedger has eight use cases in total covering supply chains, clinical trials and health data. PharmaLedger is a three-year project sponsored by the Innovative Medicines Initiative (IMI) and European Federation of Pharmaceutical Industries and Associations (efpia) that brings together a consortium made up of 29 partners who are working together to build a trusted platform using blockchain technology and in addition create many healthcare applications.

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