There are both commonality and differences along the clinical translation research phases in terms of research focuses and considerations regarding study design, implementation, and data analysis approaches.

Sound scientific practices, starting with rigorous study design, transparency, and team efforts can greatly enhance CTR. Investigators from multidisciplinary teams should work along the spectrum of CTR phases, and identify optimal practices for study design, data collection, data analysis, and results reporting to allow timely advances in the relevant field of research.

Sound scientific practices, starting with rigorous study design, transparency, and team efforts can greatly enhance CTR. Investigators from multidisciplinary teams should work along the spectrum of CTR phases, and identify optimal practices for study design, data collection, data analysis, and results reporting to allow timely advances in the relevant field of research.For the past 4 years, as part of the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) grant award number UL1TR001436, the Clinical Translational Science Institute of Southeast Wisconsin (CTSI) has used process engineering approaches to identify and understand barriers that local researchers and other stakeholders face when engaging in clinical and translational science. We describe these approaches and present preliminary results. We identified barriers from published and unpublished work at other CTSA hubs, supplemented by surveys and semi-structured interviews of CTSI faculty. We then used a multifaceted approach to organize, visualize, and analyze the barriers. We have identified 27 barriers to date. We ranked their priority for CTSI to address based on the barrier’s impact, the feasibility of intervention, and whether addressing the barrier aligned with CTSI’s institutional role. This approach provides a systematic framework to scope and address the “barriers to research problem” at CTSI institutions.The availability of large healthcare datasets offers the opportunity for researchers to navigate the traditional clinical and translational science research stages in a nonlinear manner. In particular, data scientists can harness the power of large healthcare datasets to bridge from preclinical discoveries (T0) directly to assessing population-level health impact (T4). A successful bridge from T0 to T4 does not bypass the other stages entirely; rather, effective team science makes a direct progression from T0 to T4 impactful by incorporating the perspectives of researchers from every stage of the clinical and translational science research spectrum. In this exemplar, we demonstrate how effective team science overcame challenges and, ultimately, ensured success when a diverse team of researchers worked together, using healthcare big data to test population-level substance use disorder (SUD) hypotheses generated from preclinical rodent studies. This project, called Advancing Substance use disorder Knowledge using Big Data (ASK Big Data), highlights the critical roles that data science expertise and effective team science play in quickly translating preclinical research into public health impact.

The AIDS Malignancy Consortium (AMC) conducts clinical trials of therapeutic and prevention strategies for cancer in people living with HIV. With its recent expansion to Sub-Saharan Africa and Latin America, there was a need to increase the competence of clinical investigators (CIs) to implement clinical trials in these regions.

AMC CIs were invited to complete a survey to assess role-relevance and self-perceived competence based on the Joint Task Force for Clinical Trials Competency domains.

A total of 40 AMC CIs were invited to complete the questionnaire and 35 responded to the survey. The data management and informatics and engaging with communities’ domains were lowest in the average proportion of CIs rating themselves high (scores of 3-4) for self-perceived competency (46.6% and 44.2%) and role-relevance (61.6% and 67.5%), whereas, the ethical and participant safety considerations domain resulted in the highest score for competency (86.6%) and role-relevance (93.3%). In the scientific concepts and research design domain, a high proportion rated for competency in evaluating study designs and scientific literature (71.4% and 74.3%) but a low proportion for competency for designing trials and specimen collection protocols (51.4% and 54.3%).

Given the complexity of AMC clinical research, these results provide evidence of the need to develop training for clinical research professionals across domains where self-perceived competence is low. This assessment will be used to tailor and prioritize the AMC Training Program in clinical trial development and management for AMC CIs.

Given the complexity of AMC clinical research, these results provide evidence of the need to develop training for clinical research professionals across domains where self-perceived competence is low. This assessment will be used to tailor and prioritize the AMC Training Program in clinical trial development and management for AMC CIs.

The association between surgery with general anesthesia (exposure) and cognition (outcome) among older adults has been studied with mixed conclusions. We revisited a recent analysis to provide missing data education and discuss implications of biostatistical methodology for informative dropout following dementia diagnosis.

We used data from the Mayo Clinic Study of Aging, a longitudinal study of prevalence, incidence, and risk factors for mild cognitive impairment (MCI) and dementia. selleck kinase inhibitor We fit linear mixed effects models (LMMs) to assess the association between anesthesia exposure and subsequent trajectories of cognitive

-scores assuming data missing at random, hypothesizing that exposure is associated with greater decline in cognitive function. Additionally, we used shared parameter models for informative dropout assuming data missing not at random.

A total of 1948 non-demented participants were included. Median age was 79 years, 49% were female, and 16% had MCI at enrollment. Among median follow-up of 4 study visits over 6.