What does the future of clinical trials and evidence-based medicine look like? NatureMedicine MDAndersonNews medicine clinicaltrials medicalscience
Background In recent times, advancements in technological wearables, machine learning, and data mining have initiated the transformation of evidence-based medical practices to revolutionize next-generation trials and treatments. Despite scientific advances in technology, the clinical translation of medicinal achievements is lacking.
Randomized controlled trials are not always feasible due to challenges in generating evidence in a timely and cost-effective manner. Moreover, the narrow sample population sizes limit generalizability, and many clinical questions remain unanswered. Ethical consent ethical barriers increase RCT durations. Prognostic or predictive biomarkers need to be defined, and endpoints must be defined clearly to accelerate drug development. Further, trials are challenged by staffing limitations.
Master protocols, comprising sub-studies such as umbrella studies, basket studies, platform studies, and master observational trials, are used to enhance clinical trial design progress. Future trials would be more decentralized, virtualized, and comprise digitalized endpoints for more realistic, globally harmonized, standardized real-world tracking of patient experiences and enable remote monitoring.
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Long COVID: major findings, mechanisms and recommendations - Nature Reviews MicrobiologyLong COVID is an often debilitating illness of severe symptoms that can develop during or following COVID-19. In this Review, Davis, McCorkell, Vogel and Topol explore our knowledge of long COVID and highlight key findings, including potential mechanisms, the overlap with other conditions and potential treatments. They also discuss challenges and recommendations for long COVID research and care.
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Cross-sectional associations of different types of nature exposure with psychotropic, antihypertensive and asthma medicationBackground Exposure to natural environments is thought to be beneficial for human health, but the evidence is inconsistent. Objective To examine whether exposure to green and blue spaces in urban environments is associated with mental and physical health in Finland. Methods The Helsinki Capital Region Environmental Health Survey was conducted in 2015−2016 in Helsinki, Espoo and Vantaa in Finland (n=7321). Cross-sectional associations of the amounts of residential green and blue spaces within 1 km radius around the respondent’s home (based on the Urban Atlas 2012), green and blue views from home and green space visits with self-reported use of psychotropic (anxiolytics, hypnotics and antidepressants), antihypertensive and asthma medication were examined using logistic regression models. Indicators of health behaviour, traffic-related outdoor air pollution and noise and socioeconomic status (SES) were used as covariates, the last of these also as a potential effect modifier. Results Amounts of residential green and blue spaces or green and blue views from home were not associated with medications. However, the frequency of green space visits was associated with lower odds of using psychotropic medication (OR=0.67, 95% CI 0.55 to 0.82 for 3–4 times/week; 0.78, 0.63 to 0.96 for ≥5 times/week) and antihypertensive (0.64, 0.52 to 0.78; 0.59, 0.48 to 0.74, respectively) and asthma (0.74, 0.58 to 0.94; 0.76, 0.59 to 0.99, respectively) medication use. The observed associations were attenuated by body mass index, but no consistent interactions with SES indicators were observed. Conclusions Frequent green space visits, but not the amounts of residential green or blue spaces, or green and blue views from home, were associated with less frequent use of psychotropic, antihypertensive and asthma medication in urban environments. No data available based on General Data Protection Regulation.
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Preston Police thank Mother Nature as snowy footprints help ensnare suspectsFootprints in icy snow in Preston Pic: Tony Worrall The cold weather has done Preston Police a favour with a set of snowy footprints helping officers link t
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Footprints in snow help Preston police identify suspectsOfficers investigating an offence thank 'Mother Nature for her assistance' in catching two suspects.
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Spatiotemporal evolution of the clear cell renal cell carcinoma microenvironment links intra-tumoral heterogeneity to immune escape - Genome MedicineBackground Intratumoral heterogeneity (ITH) is a hallmark of clear cell renal cell carcinoma (ccRCC) that reflects the trajectory of evolution and influences clinical prognosis. Here, we seek to elucidate how ITH and tumor evolution during immune checkpoint inhibitor (ICI) treatment can lead to therapy resistance. Methods Here, we completed a single-arm pilot study to examine the safety and feasibility of neoadjuvant nivolumab in patients with localized RCC. Primary endpoints were safety and feasibility of neoadjuvant nivolumab. Then, we spatiotemporally profiled the genomic and immunophenotypic characteristics of 29 ccRCC patients, including pre- and post-therapy samples from 17 ICI-treated patients. Deep multi-regional whole-exome and transcriptome sequencing were performed on 29 patients at different time points before and after ICI therapy. T cell repertoire was also monitored from tissue and peripheral blood collected from a subset of patients to study T cell clonal expansion during ICI therapy. Results Angiogenesis, lymphocytic infiltration, and myeloid infiltration varied significantly across regions of the same patient, potentially confounding their utility as biomarkers of ICI response. Elevated ITH associated with a constellation of both genomic features (HLA LOH, CDKN2A/B loss) and microenvironmental features, including elevated myeloid expression, reduced peripheral T cell receptor (TCR) diversity, and putative neoantigen depletion. Hypothesizing that ITH may itself play a role in shaping ICI response, we derived a transcriptomic signature associated with neoantigen depletion that strongly associated with response to ICI and targeted therapy treatment in several independent clinical trial cohorts. Conclusions These results argue that genetic and immune heterogeneity jointly co-evolve and influence response to ICI in ccRCC. Our findings have implications for future biomarker development for ICI response across ccRCC and other solid tumors and highlight im
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Maternal could be the British Grey's AnatomyThis new hospital-based drama isn't afraid to show the real ramifications of working in medicine as a mother
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