Clinical trial facilitators: A novel approach to support the execution of clinical research at the study site level.

In the summer of 2020, multiple efforts were undertaken to establish safe and effective vaccines to combat the spread of the coronavirus disease (COVID-19). In the United States (U.S.), Operation Warp Speed (OWS) was the program designated to coordinate such efforts. OWS was a partnership between the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. The U.S. Department of Veterans Affairs' (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines that were in development. Given the global importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these trials. The manuscript outlines the partnership and start-up activities led by two key divisions of the VA's Office of Research and Development's clinical research enterprise. These efforts focused on site and enterprise-level requirements for multiple trials, with one trial serving as the most prominently featured of these studies within the VA. As a result, several best practices arose that included designating clinical trial facilitators to study sites to support study initiation activities and successful study enrollment at these locations in an efficient and timely fashion.

Passive recruitment reach of a lifestyle management program to address obesity in the deep south during the COVID-19 pandemic.

Obesity is a significant public health concern, especially in the Deep South and in Mississippi where prevalence is among the worst in the nation paired, with other poor health outcomes and socioeconomic conditions. Lifestyle management programs that address modifiable risk factors, such as nutrition and physical activity, can be effective mitigation strategies to halt weight accumulation patterns and ameliorate metabolic risk factors for some populations. However, there is limited evidence regarding the implementation of effective practice models to address obesity risk in underserved and underrepresented populations, such as African Americans, and people in the stage of earlier adulthood. Furthermore, there is growing evidence supporting the impact of the COVID-19 pandemic on lifestyle management programs that should be considered in these populations. The purpose of this manuscript was to describe the development and telehealth implementation of a weight management program during the COVID-19 pandemic and provide a preliminary examination of recruitment strategies and baseline characteristics for enrolled participants. Passive recruitment (social media, web, email, and other media advertisements) resulted in 157 screening initiations, and 79 of those participants met the study inclusion criteria. Further, of the 79 eligible participants, 38 completed all study enrollment requirements and presented with metabolic abnormalities. The study findings add to the emerging body of evidence for how the pandemic may have impacted lifestyle management programs and is representative of an understudied and underrepresented population.

Clinical trial facilitators: A novel approach to support the execution of clinical research at the study site level

In the summer of 2020, multiple efforts were undertaken to establish safe and effective vaccines to combat the spread of the coronavirus disease (COVID-19). In the United States (U.S.), Operation Warp Speed (OWS) was the program designated to coordinate such efforts. OWS was a partnership between the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. The U.S. Department of Veterans Affairs' (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines that were in development. Given the global importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these trials. The manuscript outlines the partnership and start-up activities led by two key divisions of the VA's Office of Research and Development's clinical research enterprise. These efforts focused on site and enterprise-level requirements for multiple trials, with one trial serving as the most prominently featured of these studies within the VA. As a result, several best practices arose that included designating clinical trial facilitators to study sites to support study initiation activities and successful study enrollment at these locations in an efficient and timely fashion.

Introducing Curricular and Pedagogical Resuscitation (CPR): A Black Approach to Reviving the Self and Collective through Social Studies

Social studies has been lagging in the race to gain classroom instructional time due to the impact of high-stakes testing in urban schools. Furthermore, social studies can be particularly uninteresting to Black students whose diverse sociocultural histories and perspectives remain diminished or absent. Therefore, this paper advances curricular and pedagogical resuscitation (CPR) as a renewed and continuing quest to properly address and privilege Black students and their lived experiences. Employing BlackCrit, we forward CPR as a more accurate, timely, and holistic social studies approach?addressing the body, spirit, and mind of our students.