A GLOBAL TRIAL IN MEXICO
PanAmerican is in its third year conducting a phase III type 2 diabetes global trial in pediatrics. With the trial nearing completion, now is the time to reflect and understand the impact of this trial on its participants and their communities and on the future care of pediatric diabetes.
MEXICO AND CHILDHOOD DIABETES
Mexico is the leading country in pediatric obesity worldwide. The health system has exceeded its capabilities; beyond that, families in smaller towns or rural areas do not have access to health resources. There is also a lack of awareness regarding the consequences of obesity or the prevention of diabetes. This negates a sense of urgency to seek medical diagnosis and care. Even with diagnosis, there are significant challenges considering specific laboratory tests to distinguish between type 1 and type 2 diabetes are not universally available at a primary care level.
TURNING CULTURAL NORMS AND CHALLENGES INTO STRATEGY
Understanding local culture, the challenges of pediatric diabetes, and challenges specifically related to performing clinical research in Mexico, PanAmerican focused its trial strategy on five areas:
- Competitive regulatory timelines
- Effective recruitment
- Retention and close follow up of participants
- Quality data and results
- GCP and protocol compliance
To implement PanAmerican’s strategy the organization first leveraged its in-house epidemiologist to identify communities with the right patient population. Second, it leveraged its site network to select sites within these communities and with research experience. Third, it embedded its own Study Coordinator within each site to facilitate fast start-up, study training, GCP compliance, and a strong focus on recruitment and retention. To ensure only the highest accountability, each PanAmerican Study Coordinator is a trained physician with GCP experience.
ENGAGING THE COMMUNITIES
Leveraging competitive knowledge of Mexican regulatory and ethics committee processes and dedicated Study Coordinators to ensure accurate and swift submissions, PanAmerican achieved approvals in under posted times. Moving directly into recruitment, the community engagement approach started with contacting community leaders and planning health fairs.
PanAmerican medical staff were provided a public space to operate within each community and promotional support. These fairs were met with great anticipation and high turnout. During health fairs PanAmerican taught communities the importance of diet, physical activity and a healthy lifestyle.
PanAmerican also offered health screenings, including a blood pressure check, capillary glucose, and body mass index examination. If an individual was detected to have a health issue, like hyperglycemia or hypertension, PanAmerican staff referred them to our network of specialists to complete diagnosis and receive treatment.
During health fairs PanAmerican also engaged with the community in recreational activities like soccer or baseball. This helped form a bond with each community and promoted exercise.
Another component of community engagement was establishing a network of primary care physicians and specialists with referrals for the trial. Each site’s PanAmerican Study Coordinator kept in constant communication with primary care providers. The teamwork and clear communication delivered greater care for the patient.
Once a subject was enrolled in the trial the biggest challenge was retention. Participants were children that depend on an adult to come with them for the follow-up visits. This raised a number of issues: participants living in remote areas without easy access to transportation to the sites, parents that could not afford a day off work to bring their children to the site, and children that could not miss school. PanAmerican implemented a number of solutions to overcome these challenges. For example, PanAmerican Study Coordinators drove participants and their family to and from their home and PanAmerican negotiated a trial budget that included reimbursement for lost wages and transportation costs.
In the end, with earned trust, participants and their communities emerged more educated and embraced healthy lifestyle changes.
QUALITY AS A PRIORITY
PanAmerican Study Coordinators were on site for each scheduled subject visit and available to assist the principal investigator or her/his staff. In a quality role, the Study Coordinator facilitated and supported GCP compliance, adverse event reporting, data collection, source documentation completeness and accuracy.
THE BEST REWARD: GROWING OPPORTUNITIES FOR ALL
With only 20% of the sites globally, Mexico enrolled half the trial’s participants. Just as importantly, sponsor monitoring resulted in all positive audits. With the success of this trial, sponsors are not only showing a continued and growing interest in PanAmerican, but Latin America in general. While great for clinical research, this is also encouraging news for Latin American communities. With each trial comes the potential promise of a new therapy and, in the meantime, the ability for PanAmerican to continue providing health education and resources to build healthier communities.