On November 26, 2016, patient advocacy organizations in Chile came together at the School of Medicine at the University of San Sebastian in Santiago, Chile for a seminar entitled “Clinical Studies, Clinical Guidelines and Patient Registries: What do patients need to know?”
In Chile, in order to accomplish their advocacy work, patient leaders have been facing the need to interact with different target groups: medical community, pharmaceutical industry, academia, congressmen, politicians and representatives of the media. They have been forced to develop new skills, learn new concepts and professionalize their work.
We realized that there was a need for empowering the patient group representatives, giving them more information regarding three main subjects: Clinical Studies, Clinical Guidelines and Patient Registries, so that they could have a strong, clear and professional opinion in their conversations with the main stakeholders in access to the treatment advocacy process. It was particularly important to give them tools to gather information, data, and relevant clinical evidence for the decision makers to consider when evaluating reimbursement for high-cost treatments.
The first topic of the seminar was Clinical Trials. A panel composed of an investigator, Dr. Marcelo Garrido, a nurse, chief of the Clinical Studies Department, and a patient who is currently participating in a clinical trial, was assembled to give their testimony, each from their unique perspective. They defined what clinical trials are, how they are conducted and their role in discovering new treatments. Emphasis was placed on the benefits of the studies, since for many patients these kind of studies are the only option for access to a treatment, and this benefit is at risk due to the restrictions made by the newly promulgated law called Ley Ricarte Soto. Together with the panelists’ participation, an educational video was presented and an informational brochure was given to the participants.
This was a first step towards one of Alianza GIST´s projects for 2016: start the conversation about clinical trials, identify an investigator willing to participate in a Latin American Clinical Study as well as identify a health center where clinical trials could take place, and educate patients in order to demystify the idea of patients being “guinea pigs”.
The second topic was Clinical Guidelines, presented by Dra. Francisca Rodriguez, one of the co-authors of the Chilean Minister of Health’s Manual of Clinical Guidelines. The presentation taught us how clinical guidelines are made in Chile, who makes them, and the process they have to follow within the Ministry of Health in order for them to be approved. We chose this topic because it is a very important advocacy tool, as it is more feasible for a treatment to be covered by the health systems if it is included on a Clinical Guideline that is already accepted by the Ministry of Health. And if patients are involved and contribute to making the Clinical Guide, the Health Ministry may see with “good eyes” that part of their job is being accomplished by a patient advocacy group, therefore decreasing their working load.
The third topic was Patient Registries, presented by Camila Quirland, Ph.D in Pharmaceutical Sciences and a researcher/consultant at the Pharmacoeconomics and Economics Unit of the University of Chile’s School of Public Health.This topic is of great interest for GIST Chile, because in our country there are very few registries. The presentation focused attention on how patient associations are one of the most important stakeholders in order to build these kind of studies. The concept of Patient Reported Outcomes was also introduced as one strategy that can be used to represent the patient perspective on their health functional state, and how this information is becoming of great relevance in licensing procedures and post-marketing studies.
This objective was aligned, on one hand with the LRG Registry, and on the other hand with one of Salud con Datos’ country level outcome: By April, 2017, to host a meeting sponsored by academia, with patients to align speech about Patient Reported Outcomes, and by June 2017, to host a meeting with multiple stakeholders to continue the discussion of Patient Reported Outcomes.
The seminar was hosted by the academia with the participation of 50 patient representatives of 19 different pathologies from patient groups and representatives of the pharma industry, journalists, National Cancer Forum, clinicians and health centers.
To view a video (In Spanish) presenting the concept of clinical studies in Latin America, click here.