EFGCP: Bringing the Patient Voice to the PharmaLedger Project

The COVID-19 pandemic has sparked conversation and interest around clinical trials all across the world. EFGCP is bringing patient engagement and education to the PharmaLedger project.

PharmaLedger’s Blockchain consortium relies on teamwork. This ecosystem includes 29 partners from various healthcare ecosystems and tech industries. However, perhaps some of the most important key input of all comes from the patient, which PharmaLeger makes sure to represent and be heard.

We wanted to explore how PharmaLedger factors this vital stakeholder, namely you, into our project as we work towards blockchain-enabled solutions. We were able to interview Ingrid Klingmann from the European Forum for Good Clinical Practice (EFGCP), a PharmaLedger consortium member. She discussed how she puts the individual’s practical needs upfront and center of all operations, giving patients a voice in the PharmaLedger project.

Q: PharmaLedger has partnered with you as a representative of the European Forum for Good Clinical Practice. What is the EFGCP?  

Ingrid: EFGCP is an not for profit organisation that enables multi-stakeholder dialogues. We do our work to help different stakeholders have solution-oriented discussions around the development of and access to new treatments. We assist them to collaborate and share expertise in identifying and solving issues. 

Q: What led you to focus on what is now your primary stakeholder in PharmaLedger, the patient? 

Ingrid: Over the last ten to twelve years, the EFGCP has gotten progressively more involved in patient-centric activities. We have been working to enable patient engagement – something we found lacking in new medicine development.

Our project ‘PatientPartner’ sought to identify why patients weren’t sufficiently involved in the new medicine development process. The results revealed that very few patients knew anything about medicine development processes, and even fewer could give criticism and advice that was useful to the experts in various developmental areas. 

EFGCP then began educating interested patients by designing and contributing to the IMI project “European Patients Academy on Therapeutic Innovation (EUPATI)”. EUPATI works to train patients, patient experts and the general public about all aspects of the medicine development process. In EFGCP, patients are systematically engaged as co-chairs in all conferences and working party activities. Generally, the organisation champions patient engagement in all interdisciplinary interactions for the past ten years. 

Q: In your words, could you describe the role of EFGCP at PharmaLedger?

Ingrid: PharmaLedger invited the EFGCP as a multi-stakeholder discussion enabler. We have a reputation from our facilitation experience with a network of various stakeholders; ranging from representatives of different departments in healthcare companies and academic research institutions to ethics committees, competent authorities, clinical investigators and patients. 

Patients from the EFGCP network are educated in the medicine development process and aspects of access to treatment in relation to patient needs. Thus, these people can critically review methodology and strategy within PharmaLedger, assisting the experts on what their work means for people living with certain diseases. Just recently, we enabled two focus group meetings to comment on PharmaLedger’s plans to use blockchain technology for helping patients find clinical trials. We explored particularly whether they would be willing to share data if it could serve them with better accessibility to clinical trials.  

Q: As chairman of the board at EFGCP, what does your role entail? 

Ingrid: I manage the Board’s supervision and development of the organisation. We have different working parties of field specialists, such as those in quality management, paediatric and geriatric medicines development, ethics, education, patients’ roadmap to treatment and medical devices. 

My role, among other things, is to take ideas from these working parties and help them to respond to any calls. I am also involved in organising workshops and conferences, as well as training clinical research and project management staff and patients. It must all be done in a way that keeps the organisation living and growing in this difficult environment. I have been and still am working and assisting in the resourcing of several other Innovative Medicines Initiative (IMI) projects.

Q: Why has EFGCP taken the step to partner up with PharmaLedger? 

Ingrid: Firstly, we were glad to learn that several use cases will contribute to increasing the efficiency of different aspects in clinical trials. The complex nature of clinical trials is something we have always found to be an issue because every party has its challenges. Healthcare companies, for example, can highly professionally prepare and supervise clinical trials but they are dependent on the experience and professionalism of investigators who run the trial in their clinical environment and generate the data. Investigating physicians struggle to balance high workloads with recruiting patients and managing the trial process. 

Patient scarcity is also a real obstacle, seen in the fact that one-third of fully trained trial sites never actually enroll a single patient. Numerous efforts are attempted to involve more patients, like assisting and training patients in proactively finding the trials themselves. The truth is that very few patients know about them because their treating physicians are hesitant to recommend what they don’t know enough about. 

To tackle this, PharmaLedger can facilitate exchange and reliably secure patients’ health data required by an investigator to verify whether a patient might fulfil the selection criteria of a trial he or she is interested in. The responsibility that comes with such data release by patients is privacy. PharmaLedger’s secure blockchain-enabled technology would ensure that all exchanges remain confidential.

With these trial-and-patient matchmaking problems in mind, the EPGCP has been exploring ways to facilitate the safe, easy and transparent exchange of information, like complete health records. PharmaLedger technologies would help make this happen.

Q: Are there any other clinical trial benefits from the PharmaLedger capabilities?

Ingrid: The electronic informed consent process is important too. Currently, patients are required to make extra visits to trial sites and to sign informed consent forms – a burden for someone who lives far away, in addition to being ill. We are working to make remote clinical trials possible so that more assessments can be made at home, even if home is on the other side of a national border. Providing informed consent forms remotely not only enables clinical trials to involve patients from larger distances, but it will also help keep data organised and safely stored.

Q: Are you involved with any other PharmaLedger use cases outside of clinical trials?

Ingrid: I help wherever needed. I’ve also worked on the supply chain use case-wherever there is support required in understanding what is relevant to patients within that field. I am strongly involved in PharmaLedger’s activities to create the ethical and data protection infrastructure for blockchain technology.

Q: PharmaLedger is still in the beginning stages, and the roadmap is a long one. What action steps will you be taking next?

Ingrid: PharmaLedger has planned a pilot study for clinical trials, with clinical sites already secured and trained. Our next critical task will be to let communities know that we need their participation and we plan on using different patient organisations, webinars and workshops to do this.

Q: From your perspective, why is it vital for patients to seek out clinical trials? 

Ingrid: The current pandemic has widely opened doors for clinical research, as for the first time, there is a huge interest from the general public. We must use every opportunity to educate communities on these trials and to encourage people to contribute to the availability of new vaccines and treatments. While trials on new treatment options require between twenty and a few thousand subjects, for each vaccine trial we will require several ten thousand participants.

Q: Do you have any recommendations for people who want more information on clinical trials?

Ingrid: They can look at the EUPATI Clinical Trial toolbox for fact sheets, articles, presentations and various other informative resources, which is also available in 12 languages.

Q: What excites you the most about the partnership between EPCFG and PharmaLedger?

Ingrid: I am enthusiastic because PharmaLedger is a wonderful opportunity to solve some fundamental issues that have persisted until now. We are here to help find patient-centric solutions, to help make things work for all and bring such solutions to the point where they become game-changers. 

Ingrid will be participating in a Fireside Chat (Panel) – Blockchain Consortium in Scope – Summit for Clinical Ops Executives on the 2nd of March. She will also be a moderator for the Healthcare Data Privacy and Ownership panel discussion at this year’s European Blockchain Convention happening on the 12th through 16th of April.

Join us for our free open webinar “A Trust-Centric Healthcare Journey Part II: Clinical Trial & Health Data Use Cases,” where you’ll find out all about the latest development in our Clinical Trial and Health Data use cases. You can choose from two dates: the 24th of February and the 3rd of March. Also, make sure to sign up for our newsletter below to receive the latest updates about the PharmaLedger project.


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