An interview with Patient Advocacy Manager Begonya Nafria Escalera
Patient centricity is one of the key issues in clinical trials at the moment and one that was explored extensively at Partnerships in Clinical Trials Europe in Vienna last week. As a Patient Advocacy Manager at Sant Joan de Déu Children’s Hospital in Barcelona, Begonya Nafria Escalera spends more time than most exploring strategies that put the patient at the core of research.
We spoke to her about the state of patient centricity in the industry today, as well as the role technology can play in its future.
What does your role at Sant Joan de Déu Hospital involve?
‘My responsibilities are as a patient liaison in two projects; Rare Commons and Kids Barcelona.
Rare Commons is a research platform 2.0 for clinical knowledge of pediatric rare diseases. Using social media, we work very closely with families to improve our scientific knowledge of the disease.
Kids Barcelona is the name of our hospital’s Young Patients' Advisory Group (YPAG). After training in clinical research and drug development the team help us as scientific council in different projects, most of them related to clinical trials. The only way to develop studies that take account of the necessities and specificities of the children is with their involvement.’
How well do you think the industry currently works with patients in clinical trials?
‘We have more than 20 years of experience with adult patients, but far more limited experience with children and young patients. At first it can seem difficult or even impossible, but the experience of teams such as our YPAG demonstrate that it is not only possible, it is the best and right way to develop clinical trials.
The first YPAG in Europe was established in 2006. Now all the existing groups linked to pediatric hospitals around Europe are working as a network with the aim of making it easier for researchers, pharma companies and regulators to approach our teams. The network is called eYPAGnet and we are working to gain approval as an Enpr-EMA network in the future.
We trust in the benefits of involving children and young patients in research and drug development, and we need to design a standardized working system that facilitates collaboration in projects as a mandatory requirement. The pilot projects we have participated in have demonstrated that this is the correct process to develop clinical trials for pediatric populations. Now is the moment to make it possible in the maximum number of projects, and national and European regulators have encouraged our network to work in this direction.’
How important are patient advocacy groups and what role can they play?
‘Patients and families (especially in pediatrics) need the support of patient advocacy groups than can represent their needs and interests at the different stages of clinical research.
I think education in this field is the responsibility of patient associations and research centers and we need to train more patient advocates; it is a huge responsibility to represent a group of patients or a specific disease. The investment in educational programs and resources is a social responsibility of all the stakeholders that are involved in the process of drug development. An educated patient has the capability to improve our work.’
How is social media (and technology more generally) changing how clinical trials function and the role of the patient within them? What benefits can it bring?
‘Everyone is now a user of social media and patients aren't excluded. They generally have a high level of social media use; more than clinicians or researchers. We can't forget this fact, and we need to take advantage of it.
One of the main uses of the internet is to search information about health and in my daily professional field in pediatric rare diseases, families are very active in using social media. They are connected every day with families around the world through open groups on Facebook where they share information and questions about their child’s disease.
We can use this high level of competence in using digital tools to approach families for research. On the Rare Commons social platform 2.0, relatives of children with a rare disease share clinical data with our researchers. With their help we are describing the natural history of the disease, studying the correlation between genotype and phenotype in genetic disorders, and we can also assess patients for clinical trials. The exhaustive clinical data that we can access is allowing us to apply inclusion and exclusion criteria. This is not the future, it is the present.
Families are fighting day by day against the disease, but also to find the right treatment for a better quality of life for their child. When we don't have any possible treatment for them, collaboration in a clinical trial is often the only option, for the benefit of future patients, even if perhaps not for their child.’
What ethical issues are there around using social media for patient recruitment?
‘The main ethical concern is the use of commercial open social networks. In these cases, the regulations are severe, as users can share health data in an open digital space without any option to anonymize it.
This is the reason we designed our own social media platform at the hospital that patients and families need a username and password to access. All the data is saved anonymously through processes that meet the personal data regulations. The data is stored on the hospital’s servers, with a daily system to record security copies.
These are the main ethical concerns over the use of social media for clinical research and trials, but they can be solved by the use of technology that guarantees all the regulatory aspects are respected.’