Part I: Insights on the Clinical Trial Landscape in Argentina

Part I: Insights on the Clinical Trial Landscape in Argentina

Posted by BBK on Tue, Sep 8, 2015

Fundacion_UnICA2BBK welcomes Laura Ardigó as our guest contributor on the blog today. Laura is an independent clinical research consultant with broad experience working in multinational pharmaceutical companies and is currently the President at Fundación UnICA (United for Clinical Research in Argentina). She will be sharing her insights into the patient recruitment landscape of Latin America, discussing industry trends, assumptions, and how technologies and innovations can most effectively be used to support clinical research while keeping the patient first.

Please share with us a little about you and your organization’s history, services, and relation to the clinical R&D industry.

I am a physician specializing in family medicine, an independent clinical research consultant, and President of the UnICA (United for Clinical Research in Argentina) Foundation, an independent non-profit organization dedicated to community outreach regarding clinical research. With over 13 years of experience in clinical research in Argentina and Latin America at large, I’ve participated in over 30 clinical studies across multiple study phases and medical disciplines.

The Foundation’s mission is to ensure that the general public and healthcare professionals of Argentina have better access to information about ongoing clinical research opportunities and to help them develop a better understanding of these opportunities. We seek to provide the right information and guidance for people who may be interested in participating in clinical research or who may know someone who would like to learn more about a clinical research opportunity.

What is the general sentiment towards participating in clinical research in Argentina?

Generally, patients and healthcare professionals are receptive to information regarding clinical research opportunities, but the overall population is not really aware of the opportunities available to them.  Unfortunately, there is no readily accessible clinical trial registry tailored for the general public. The lack of information surrounding clinical research generates a gap between the research community, healthcare professionals and patients, contributing to misconceptions that are not easily deconstructed. This is the main reason why we decided to fund UnICA. We are working to become a centralized source of information regarding ongoing clinical study opportunities in Argentina for both the general public and the medical community.

As patient centricity is currently the major industry ‘buzzword,’ what can sponsors do to ensure the best clinical trial experience for patients?

Sponsors need to become involved with community outreach activities, not necessarily as pharma employees, but as individuals with the opportunity to volunteer and share their knowledge.  Additionally, patients need to be involved from the start of the study, and their medical needs and concerns need to be addressed throughout its duration. Developing tools such as mobile apps and technologies to educate patients on the clinical research process with new formats like infographics, videos, and podcasts would help to address patients’ questions and concerns as well.  Lastly, sponsors need to recognize and appreciate the patients for their complete dedication and participation in the study. Unfortunately, many clinical study patients are unaware of the results of the study in which they’ve participated; however, patients are demanding greater endpoint data transparency, and this demand will only continue to increase.

What can sites do to ensure the best clinical trial experience for patients?

In Argentina, site staff and physicians remain close with study participants and are very receptive to the needs of the patients and their families. It is important that sites are also receptive to any interest expressed by healthcare professionals involved with patients’ care outside of the study. When it comes to referring physicians, site staff and investigators must make an effort to empathize with the originating physician. If this were your patient, wouldn’t you like to know about the trial, the study drug, and the possible risks and benefits associated? Wouldn’t this help to develop trust and build better relationships among the study community?

Additionally, sites need to begin using available technologies to better facilitate the clinical trial process. Social media platforms and clinical research websites are a great resource for reaching a potential community of patients. Some investigators in Argentina are already working with SMS functionality to enhance protocol retention, compliance, and long-term follow up. In the next entry of this two-part blog series, I will explore those technologies, most notably offered by BBK, and how their service offerings can best be adapted for use in Argentina.