2. PharmaLedger’s Clinical Trial eConsent Use Case

Clinical Trial eConsent | Watch PharmaLedger’s Use Case presentation and topic-specific Q&A – join us in our Trust-Centric Healthcare Journey.

Kicking off year two of the PharmaLedger project, we brought our partners together to introduce the challenges, solutions and added value of our four use cases under the umbrella of clinical trials and health data. We discussed the progress of these use cases by hosting our second Open Webinar: “A Trust-Centric Healthcare Journey Part II,” on the 24th of February and the 3rd of March. 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 eConsent Use Case

Following Clinical Trial eRecruitment, the second use case covered in the webinar was Clinical Trial eConsent, presented by its co-leads: Despina Daliani (Onorach) and Hernando Giraldo (Boehringer Ingelheim). 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 included to help you navigate through the presentation.

The Flow of Clinical Trials: The Problem (0:42)

After a patient has been approached for participating in a clinical trial, the next step is for them to be provided with all trial information and confirm their voluntary participation by signing the informed consent form (ICF). After the informed consent form has been signed, the patient is screened to confirm their eligibility, and their data gets collected and evaluated in relation to what the trial requires. Finally, the data is shared with the appropriate permissioned users participating in the study. 

Currently, the informed consent and the rest processes are done manually. The annual reports from the regulatory authorities from inspection shows the following problematic statistics:

The Flow of Clinical Trials Through Blockchain (2:22)

The informed consent is the most critical aspect of a clinical trial – without patient consent, no trial can be conducted. Given the challenges we face through this manual process, there is a lot of room for improvement regarding protocol compliance, the completeness of data, as well as the overall quality. PharmaLedger believes that using blockchain technology, which is a one shared source of truth, to transition aspects of the Informed Consent Process from a manual to an automated process will tackle these problem areas head on by creating:

  • Immutability 
  • Automation
  • Trust
  • Real-time updates 

Key Information Provided in the Informed Consent (3:28) 

In the informed consent process, participants are briefed on the following:

This manual process is complicated, but extremely important. It is key that the language is understandable, the participants can ask as many questions as they want, and that there is enough time given to the potential participants to finalise their decisions for participation. PharmaLedger believes that blockchain can ensure adherence to a patient’s consent, privacy and safety during a trial.

The Current Situation (5:02)

There are a wide range of problems that exist within the current informed consent process for clinical trials:

  • The process is complex and inefficient
  • Non-compliance risks exist at every touch point
  • Inability to have one unified platform for process actors to manage trial conduct result in siloed, less transparent and confusing data
  • Spot-check inspections to identify non-compliance are limited

But, as the situation stands, Good Clinical Practice (GCP) inspections only identify between 2% to 7% of all consent related issues. 

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

Blockchain Powered Consent: The Future (5:39)

PharmaLedger believes that blockchain can be absolutely transformative to any industry – even beyond healthcare. In the presentation, our speakers walk us through an example of how this technology has been tested and proven to track certain food item deliveries from the source, to the point of sale. The metric takeaway from this is that for certain food items in the US, the time needed to trace their prominence went from 7 days, to 2.2 seconds. PharmaLedger’s Clinical Trial eConsent use case aims to apply this proof of concept to clinical trials.

Why Blockchain for Clinical Trial Informed Consent? (6:41)

Conducting a clinical trial in a blockchain ecosystem brings in these elements that are missing today: transparency, security, trust and efficiency:

With blockchain, trial data would no longer be siloed. There would be an immutable record of participant consent available to appropriate permissioned users (patients, sponsors, clinical research organisations, ethics committee’s, etc.). So, even when the participant opts out, the status is seen by the laboratories as well as the other actors. This means sample processing, patient privacy rights, and adherence are immediately seen. The regulatory authority role switches from oversight to first-sight.

Blockchain would allow a significant decrease in fraudulent data while ensuring adherence to compliance procedures. These automated processes would in turn be in line with Good Clinical Practices (GCP).

Blockchain would allow patients ownership and the ability to decide which data information is shared. It would also create a greater consistency of information viewed by relevant participants.

Blockchain would allow real-time captures and real-time reporting offering transparency via regulators through their permission views. This changes the landscape for everyone, from regulatory folks, to patients, providing better awareness and visibility of consent status changes or protocol changes almost instantly.

Value Proposition to Stakeholders (7:18)

PharmaLedger’s proposed solution for Clinical Trial eConsent would bring immense value to all stakeholders involved:

  • Reduced process time
  • Trust, safety, integrity and traceability
  • Reduced operational expenses 
  • Real-time updates and changes

You can see the benefits our blockchain-enabled eConsent use brings for each individual stakeholder below:

In conclusion, PharmaLedger’s Clinical Trial eConsent use case aims to make the switch from the current, manual and paper-based informed consent process, to an automated, blockchain-based process. We believe that this solution would reduce the administrative burden, cost pressure, and compliance challenges of the informed consent process for clinical trials. This in return would accelerate clinical development, while also empowering patients to have full control over their own data.

Poll Results (8:45)

During the Clinical Trial eConsent presentation, attendees were invited to answer the following poll question: What do you feel is the most important step in a clinical trial?

  • Informed Consent (52%)
  • Data collection & Analysis (36%)
  • Data sharing (12%)
  • Screening (0%)

Over half (52%) of respondents agreed that the Informed Consent is the most important part of a clinical trial.

Q&A (9:28)

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.

  • Is there any concept available about how to deal with future research consents as these last longer then the actual study? (9:32)
  • How will the identification of the patient be ensured in a remote setting? (10:58)
  • We use the data from trials for many secondary uses, would this still be possible or require “reconsent”? This would be an issue as we then may not have full dataset. (12:03)
  • How does PharmaLedger’s eConsent solution differentiate from existing eConsent SaaS solutions? (13:48)
  • How do you plan to get doctors and sites and regulators on board with this idea? (15:08)
  • Blockchain has been used without specificity. Which ‘blockchain’ platform? And how do you intend to scale the voluminous data processing and use? (16:28)
  • Who/which suppliers would make these blockchains a reality? This is costly work and there are no off-the-shelf solutions. (19:08)
  • Can you please describe the process for achieving agreement on the data governance by all consortiums for all/any of these studies? (20:15)
  • How to join PharmaLedger ? We have developed an scalable use case that fits 100%. (22:06)
  • Who will manage these blockchain platforms? (23:15)
  • When could patients expect solutions to be available? (23:58)
  • Given that there are other similar solutions in development, how will you build the critical mass to ensure yours is successful? (25:23)
  • Will Big Pharma own these solutions? (26:31)
  • How many ledgers and nodes do you have on a possible chain code? (27:17)

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, IoT Medical Devices!

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

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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