Approaches for Measuring Inclusive Demographics Across Youth Enjoy Science Cancer Research Training Programs.

The National Cancer Institute's (NCI) Youth Enjoy Science Program (YES) funds initiatives to support the cancer research training and career ambitions of middle school through undergraduate students from populations underrepresented in the biomedical sciences. The program has funded 16 institutions nationally as of January 2022. Given the program's focus on increasing diversity within the cancer research workforce, demographic characteristics of YES trainees provide essential information about the populations being served and program effectiveness. Six programs formed an interest group focused on trainee demographics and surveyed all YES grantees about their demographic data practices. Fifteen programs (94%) completed the survey. Survey data were analyzed through descriptive statistics and thematic coding. Findings revealed considerable variability in programs' approach to demographic data, including which demographics were measured, how they were operationalized, and when and how the data were collected. Half of YES programs (53%) could report underrepresented populations in biomedical research among trainees using consistent definitions. Most programs described efforts to improve their demographic data practices; however, challenges remained for the vast majority. In consideration of these findings, we offer recommendations for inclusive demographic data practices to better define and retain underrepresented populations in biomedical sciences.

Best Practices to Support Early-Stage Career URM Students with Virtual Enhancements to In-Person Experiential Learning.

STEM training of college-bound and college students has reliably employed hands-on experiential learning by placing students in on-campus research settings. Dana-Farber/Harvard Cancer Center's Young Empowered Scientists for ContinUed Research Engagement (DF/HCC's YES for CURE) program introduces Massachusetts high school and college students from underrepresented populations to cancer research by immersing them in scientific and nursing research environments. Amidst the COVID-19 pandemic, the 2020 summer program was re-designed and delivered virtually for 45 students. Because the program spans three years, we could evaluate the experiences of 18 students (cohort 2) who completed the 2019 (pre-pandemic) and 2020 (pandemic) summer programs. Analysis of cohort 2 data revealed three areas where students felt their competence improved with virtual programming (i.e., effective communication of ideas, access to high caliber speakers, engagement with program leaders) and two areas where it declined significantly (i.e., engaging other students, learning lab material). Additionally, student-reported competence to perform 21 scientific research and seven critical thinking processes were not negatively impacted by the virtual transition. Herein, we describe the adaptation of DF/HCC's YES for CURE program to a virtual format and the impact on students as a resource for institutions interested in enhancing their STEM training programs with virtual programming.

CLINICAL TRIALS IN COVID-19 MANAGEMENT & PREVENTION: A META-EPIDEMIOLOGICAL STUDY EXAMINING METHODOLOGICAL QUALITY

BackgroundThe coronavirus disease (Covid-19) pandemic has produced a large number of clinical trial reports with unprecedented rapidity, raising concerns about methodological quality and potential for research waste. ObjectivesTo describe the characteristics of randomized clinical trials (RCTs) investigating prophylaxis or treatment of Covid-19 infection and examine the effect of trial characteristics on whether the study reported a statistically significant effect on the primary outcome(s). Study DesignMeta-epidemiological study of Covid-19 treatment and prophylaxis RCTs. Eligibility criteriaEnglish-language RCTs (peer-reviewed or preprint) that evaluated pharmacologic agents or blood products compared to standard care, placebo, or an active comparator among participants with suspected or confirmed Covid-19 or at risk for Covid-19. We excluded trials of vaccines or traditional herbal medicines. Information sourcesWe searched 25 databases in the US Centre for Disease Control Downloadable Database from January 1 to October 21, 2020. Trial appraisal and synthesis methodsWe extracted trial characteristics including number of centres, funding sources (industry versus non-industry), and sample size. We assessed risk of bias (RoB) using the modified Cochrane RoB 2.0 Tool. We used descriptive statistics to summarize trial characteristics and logistic regression to evaluate the association between RoB due to the randomization process, centre status (single vs. multicentre), funding source, and sample size, and statistically significant effect in the primary outcome. ResultsWe included 91 RCTs (46,802 participants) evaluating Covid-19 therapeutic drugs (n = 76), blood products (n = 9) or prophylactic drugs (n = 6). Of these, 40 (44%) were single-centre, 23 (25.3%) enrolled < 50 patients, and 28 (30.8%) received industry funding. RoB varied across trials, with high or probably high overall RoB in 75 (82.4%) trials, most frequently due to deviations from the intended protocol (including blinding) and randomization processes. Thirty-eight trials (41.8%) found a statistically significant effect in the primary outcome. RoB due randomization (odds ratio [OR] 3.77, 95% confidence interval [CI], 1.47 to 9.72) and single centre trials (OR 3.15, 95% CI, 1.25 to 7.97) were associated with higher likelihood of finding a statistically significant effect. ConclusionsThere was high variability in RoB amongst Covid-19 trials. RoB attributed to the randomization process and single centre status were associated with a three-fold increase in the odds of finding a statistically significant effect. Researchers, funders, and knowledge users should remain cognizant of the impact of study characteristics, including RoB, on trial results when designing, conducting, and appraising Covid-19 trials.

Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.

BACKGROUND: Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings. METHODS: Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost. CONCLUSION: TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.

Cancer disparities: developing a multidisciplinary research agenda - preface.

In this Special Issue, we present a series of papers concerned with developing a multidisciplinary research agenda to address social disparities in cancer. Motivating this Special Issue are two concerns: (1) despite major advances in knowledge during the 20th century about the extent, determinants, treatment, and prevention of cancer, social disparities in cancer, including within the United States, remain serious, persistent, and require redress; and (2) huge gaps in knowledge exist regarding the causes of and solutions to social disparities in cancer across the full cancer continuum, from prevention to occurrence to diagnosis to treatment and, all too often, to death. Consequently, critical research is critically needed, both to answer the unanswered questions and to ascertain why existing knowledge is not implemented to reduce and eliminate these disparities. To help advance work in this field, we share papers developed for a January 2004 workshop on cancer disparities held at the Dana Farber/Harvard Cancer Center (DF/HCC), in Boston, MA. Topics addressed include: the definition and magnitude of, and programmatic responses to, social disparities in cancer, plus development of a systematic approach to raising research questions to address cancer disparities, using the case examples of breast, cervix, colon, and prostate cancer.