COVID-19 is a global threat impacting the health and daily life of millions. Prophylactics and therapeutics are in development. As a research organization, PanAmerican’s job during these times is to support the clinical development of vaccine and drug product candidates. This is especially critical in light of PanAmerican’s previous experience conducting a clinical trial during a Pandemic. Due to this novel experience, PanAmerican is providing this document to educate its clients and the research community on lessons learned and to provide best practices developed from firsthand experience.
The last documented pandemic in our lifetime was Pandemic Influenza A (H1N1) in 2009-2010, which had its epicenter in Mexico. Two core members of the PanAmerican Team, Kathy Lenhard RN, CEO, and Eulises Franco MD, Senior Medical Advisor and Epidemiologist, were responsible for the operational planning, preparation, and execution of the A (H1N1) clinical trial in Mexico during the pandemic. [Vaccine 29 (2011) 7826-7834]. The trial’s goal was to rapidly evaluate the safety and efficacy of a novel vaccine.
The successful trial enrolled 4563 healthy adults (18-64 yrs old) in five months. This unprecedented outcome resulted from fast regulatory timelines, community engagement, efficient recruitment, precise logistical planning and execution, established communication channels, motivated staff, and the collection of quality data. Here are the best practices that drove the trial.
- Established strategic execution plan and clear communication plan and channels. Communication plan must include sponsor, CRO, PI communications; issue escalation and resolution; and document, supply, and sample management control. Issue resolution must permit creative and adaptable solutions.
- Regulatory documents, including translations, were checked and double checked. Any error can delay approval and is unacceptable.
- Engaged with the ethics committee and government early to request expeditious approval. The A (H1N1) trial received ethics approval in 24 hours from submission and approval from COFEPRIS in 5 weeks, versus the standard 4-5 months.
- Operations worked intimately with an experienced and local customs broker on importation and exportation licensure and execution. Operations, the broker, and courier all facilitated and ensured cold chain management, including actually walking all IP shipments through customs and reviewing temptales until the IP was appropriately stored at the site in a 2-8 degree Celsius constant temperature refrigerator.
- The site and site staff were selected for their research experience and were trained extensively on the protocol. This training extended to site staff physicians, nurses, study coordinators and laboratory specialists. Ongoing or re-training was also rapidly deployed to address issue trends and new information.
- Nurses were assigned to two groups. One group delivered the vaccine and the other blinded group performed all the injection site assessments.
- Operations and project management resided on-site for close oversight, fast issue resolution, and site support considering pandemic conditions and high enrollment.
- A unique compressed database for data management was developed. This database was built, tested, and made live in 22 days for Part A of the trial and in 32 days for Part B.
- Due to fear and disinformation, the trial relied heavily on community engagement for education and recruitment. Population centers and communities were targeted for education on A (H1N1) and on clinical research. Such engagement began at the local leader level and extended to clinics, schools, and sporting events. After establishing trust and rapport, public health fairs and screenings were conducted and a referral database built.
- Buses were used to transport participants from their communities to the clinical site and a lunch was provided after the study visit.
- To consent large volumes of participants, a study overview was provided in a group setting followed by private consent discussions.
- A call center was established to field participant questions, reporting of adverse events, pregnancies, or any other issues that impacted participants.
- Extended working periods were established: there were 5-10 CRAs on site every week from first subject in to last subject out. Shifts were 12 hours and included weekends. To address burnout, shifts rotated every 2 weeks.
- Special teams were formed to monitor staff schedules and strategic working groups (e.g. informed consent, follow-up and resolution, deviation tracking, query resolution).
- Infrastructure to manage sera samples was put in place including a tracking system, monitoring and analysis. Shipments required advance planning due to high volumes. The A (H1N1) trial shipped 41,040 samples from Mexico to labs in the U.S. for analysis.
- Daily detailed safety review occurred. This involved SAE processing, reporting and tracking, with on-site support and quality data review. This was in conjunction with a formed Data Safety Monitoring Board who met at regular intervals or as needed.
- In advance of study close-out, procedures and processes were in place for archiving study documents, vaccine destruction, and the creation of the clinical study report.
In the midst of the pandemic in Mexico, the trial exceeded expectations in terms of timelines, enrollment, and quality data and resulted in crucial safety and efficacy information for a novel A (H1N1) vaccine. For more information or to discuss your upcoming COVID-19 trials, please contact PanAmerican at firstname.lastname@example.org or call 301-633-6602.
PanAmerican Clinical Research provides clinical operations, regulatory support, patient recruitment, home visits, and research sites in Texas and throughout all of Latin America. PanAmerican employs infectious disease physicians and epidemiologists and its research sites have a strong emphasis on infectious disease and the ability to recruit not only from their established databases, but also in the community. PanAmerican is able to support all trials, no matter the complexity or size, due to its strategic partnership with global CROs and with CAIMED, Latin America’s most experienced infectious disease research network. Contact PanAmerican to learn more: email@example.com