Abstract B086: Planning for the unexpected: Strategies for maintaining a robust clinical trial rogram
Authors: Melecio Lemuel , Hernandez Jessica , Chevere Victor Carlo , Rodriguez Luz , Cruz-Correa Marcia 
Published: August 2020

Abstract
As researchers engaged in conducting clinical trials, maintaining the well-being of our participants is the most important objective and above any other study research objective. Similarly, research protocols have well-delineated participant and sponsor communication plans as well as clearly outlined loss-to-follow-up algorithms. However, limited plans are developed to help investigators deal with unforeseen disasters such as those caused by natural disasters or political/governmental problems, such as government closeouts, long-term strikes or political unrest, that we may encounter during the time span of the study. Unexpected events, like natural disasters, may cause a great amount of infrastructure damage and affect our everyday life and the lives of research participants. Anticipation of and preparation for unexpected events such as natural disasters would allow development of strategies that are incorporated into the research protocol and will ultimately provide a road map for participants, investigators and sponsors. Hurricane Maria devastated Puerto Rico on September 20, 2017, causing damage to virtually all infrastructures in the island. All basic life necessities in Puerto Rico were severely compromised. FEMA reported that during the first 30 days after Hurricane Maria, only 61% of the population had cell phone service, 69% had potable water and 21% had power. In addition, communication by roads was severely impaired as roads' integrity and accessibility were largely disrupted to several parts of the island. Hurricane Maria taught us how our duty as clinical investigators extended beyond the immediate research protocol needs and included providing support in other areas that affected the well-being of our research participants. We identified four main challenges faced as a result of the natural disaster: (1) infrastructure damage, (2) shortage of basic necessities (water, fuel, food, medications, etc.), (3) transportation difficulties and (4) communication failure. We will discuss the strategies and interventions that allowed us to continue our research enterprise, protect participants' lives and provide support during the post-natural disaster emergency. Surviving Hurricane Maria has given us a new perspective on planning for emergencies and developing redundant systems, operating procedures and protocols that incorporate loss of infrastructure support. Moreover, budgets that include funds to support transportation and communications costs to sustain the clinical research enterprise during natural disasters or other unexpected social/political events should be developed. In addition, research protocols should have clear algorithms for emergencies (preapproved by sponsors and the IRB) and extended loss of communication.
Citation Format: Lemuel Melecio, Jessica Hernandez, Victor Carlo Chevere, Luz Rodriguez, Marcia Cruz-Correa. Planning for the unexpected: Strategies for maintaining a robust clinical trial rogram [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr B086.