Patient Partnering in Clinical Development

This presentation will use NICE’s experience of working with patients and carers to demonstrate the value of the patient voice in developing guidance at a national level. Alongside this the presentation will discuss mechanisms by which these population-level guidance recommendations can support patients and clinicians in making indvidualised decisions about treatment and care.

AI has the potential to transform key steps of clinical trial design from study preparation to execution towards improving trial success rates, thus lowering the pharma R&D burden.

Decentralized Clinical Trials (DCTs), which put the patient at the center of the trial experience and incorporate digital technologies, and artificial intelligence (AI) are combining to transform clinical research. Organizations are marrying DCT methodologies with AI in innovative ways to reshape workflows across the clinical lifecycle, from trial design and patient recruitment to evidence generation—and are seeing striking decreases in both the time and cost of clinical studies.

Today, there are at least 25,000 clinical trials offering a form of open source data. With the right analytical tools and AI, the industry can take advantage of this rich data to optimize patient recruitment, increase patient retention, reduce timelines, and maximize study results in future trials. AI can also expedite target validation, trial design, and patient identification.

DCTs can also reduce time and cost of clinical studies by expanding patient access and retention as a result of allowing patients to participate safely and conveniently in their homes. The net effect is an improvement in data quality as site-based transcription is eliminated plus an increase in efficiency for patients, sites, and study teams. Together, AI and DCTs can be a powerful force.

DCTs fuel AI engines since they inherently capture massive real-world, real-time data from diverse patient populations more inclusive of the diverse world in which we live. By combining both innovations, companies will improve three crucial areas of clinical trials: trial design, patient recruitment, and evidence generation.

Clinical Trials as we knew them before Covid-19 pandemic, may have become the old version of clinical trials and decentralized clinical trials a new paradigm that insists on coming to stay.

While decentralized clinical trials is not something new, it has been just recently when it is in everybody’s mouth.

With the extraordinary need for a different approach to face to face interactions and specially in order to stay away from the pandemic most demanded locations, hospitals, what was mostly the “future” for clinical trials, suddenly become the priority.

Does it mean the term “decentralized clinical trials” is just one easy way to describe the new version of clinical trials? Can we implement all what we envision? How ready are the different stakeholders to embrace such decentralization?

Answers to those questions and more will be discussed during our meeting, looking forward to see you all!

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More details available soon

Over the course of the last year, the traditional clinical trial model was flipped upside down. Sites, patients and sponsors were forced to think about study conduct in an entirely different way. As a result, DCT studies have become a “new” normal. Enabling research participation from home using a decentralized model seems to be the perfect solution to improving patient accessibility and diversity. But is it really that simple?

In this session, we will share feedback and guidance from patients and physicians on successfully deploying DCTs to improve ethnic, racial, cultural, and linguistic diversity in research and ensure the best result from a site, patient, and sponsor perspective.

Patient Advocacy is a strategic function within the company that serves as a bridge to establish relationship between the patient community and the industry, serving to inform research, development and regulatory strategies, support market access processes.

By putting patients, caregivers in the center of everything we do not only serve patients and making a difference in their lives but also enables biopharmaceutical companies to better understand their conditions, symptoms to develop appropriate diagnostic tools and innovative medicines.

Patient Advocacy impacts every part of the business like research programs, patient focused drug development, clinical study design, supports HEOR and data collection, regulatory and market access processes therefore the importance of early patient involvement is key.

To be able to achieve all of this we need to develop trustful relationships with the patient groups and collaborate in partnership, not only hear but listen to the patients.

By focusing on the issues that are critical to patients and involving them in the decision making process enables them to be part of the mechanism by having a positive impact shaping clinical study designs, health care policies.

We shall empower patient advocates and communities to increase their ability to serve members through growth and independence and strengthen their belief that their voice matters.

Background
Children and young people’s participation in health, research and innovation is a fragmented practice across Europe. Minors have the same rights than adults. When they are enough mature they deserve, beyond the right to express their views, the opportunity to be heard and included in any activity that can matters them. This applies to health, research and innovation.
In the last decades, many industries have developed the right methodologies and processes to involve their customers in the design and delivery of its services or products.
Health sector time by time is moving to this new paradigm of cross-collaboration between the different stakeholders involved. When these activities refer to children and young people, to guarantee their active engagement for co-designing patient centric initiatives it’s essential to educate them in this role.

Aims
Develop the YEAH (Youngsters Engagement Active in Health) training programme to educate young people in the field of patient engagement in the design of clinical trials and in the development of medical devices addressed to the paediatric population.
Co-design the seven training modules, including specifically activities related to the engagement of young people and how to assess the patient experience of the young people participating in clinical trials.

Methods
Active involvement of members of three Young Person’s Advisory Groups members from the teams of Liverpool, Riga and Barcelona in the co-creation of the educational resources to be integrated in a digital toolkit.

Results
Digital toolkit addressed to train members of YPAGs, High School students and young citizens. Accessible in English and in Spanish. Addressed to YPAGS, patients organizations and secondary schools.
Discussion
Involve children and young people in the co-design of clinical trials and medical devices guarantees suitable products to this target population. Prior to involve them and to guarantee a meaningful participation it is essential to educate them in this innovative citizens’ involvement field.

The presentation will cover the following points:

• Progress on medical science is a priority for health industry and patients
• Integration of patients` needs and experiences, in additional to clinical and academic knowledge, seems an effective way to develop innovative and effectives drugs
• The incorporation of patients as active partners in the R&D process needs to be extended across the whole process of R&D in a coordinated and effective manner
• These exchanges should be based on transparency, collaboration and mutual interest
• Practical examples of PE in R&D will be used to illustrate the different ways to engage with patients and the impact on projects

The session will be moderated by Doris Christiane Schmitt – Consultant for patient communication

Biomarkers are getting more and more important in order to identify subgroups for personalized Oncology. Breast Cancer or Lung cancer are good examples for individual treatment options and longer survival rates.

• How can we reach out for more voice in local health care system?
• What can we do to raise awareness of better information in testing cancer tissue in public?
• Are there already best practic examples in patient organizations?