scholarly journals The time is now: role of pragmatic clinical trials in guiding response to global pandemics

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aws Almufleh ◽  
Jacob Joseph
Keyword(s):  
Clinical Trials ◽  
Clinical Evidence ◽  
Randomized Clinical Trials ◽  
Sufficient Evidence ◽  
Regulatory Authorities ◽  
Pragmatic Clinical Trials ◽  
Research Platform ◽  
Barriers And Challenges ◽  
Subsequent Wave

AbstractAlong with its heavy toll of morbidity and mortality, the coronavirus disease 2019 (COVID-19) pandemic exposed several limitations of the current global research response. The slow and inefficient process of carrying out traditional randomized clinical trials led regulatory authorities to hastily approve treatments and tests without sufficient evidence of safety and efficacy.We here outline issues with the current research platform, summarize shortcomings of traditional randomized clinical trials particularly apparent at the time of pandemics, and highlight the advantages of pragmatic clinical trials as an alternative to rapidly generate the needed clinical evidence. We further discuss barriers and challenges to pragmatic clinical trials implementation and explore opportunities for research institutions and regulatory authorities to facilitate widespread adoption of this vital research tool.As a subsequent wave of COVID-19, and/or another epidemic, are all but inevitable in our lifetime, we must ensure that our research infrastructure is conducive to carrying out pragmatic clinical trials to expeditiously generate the needed evidence and blunt the epidemic’s toll on human lives and livelihoods.

scholarly journals COVID-19: Role of Nutrition and Supplementation

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 976
Author(s):  
Fiorenzo Moscatelli ◽  
Francesco Sessa ◽  
Anna Valenzano ◽  
Rita Polito ◽  
Vincenzo Monda ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Viral Infections ◽  
Overweight And Obesity ◽  
Shortness Of Breath ◽  
Nutritional Interventions ◽  
The World ◽  
Diet Regimen ◽  
Specific Diet

At the end of 2019, a new coronavirus (COVID-19) appeared on the world scene, which mainly affects the respiratory system, causing pneumonia and multi-organ failure, and, although it starts with common symptoms such as shortness of breath and fever, in about 2–3% of cases it leads to death. Unfortunately, to date, no specific treatments have been found for the cure of this virus and, therefore, it is advisable to implement all possible strategies in order to prevent infection. In this context, it is important to better define the role of all behaviors, in particular nutrition, in order to establish whether these can both prevent infection and improve the outcome of the disease in patients with COVID-19. In the literature, it is widely shown that states of malnutrition, overweight, and obesity negatively affect the immune system, leading to viral infections, and several studies have shown that nutritional interventions can act as immunostimulators, helping to prevent viral infections. Even if several measures, such as the assumption of a specific diet regimen, the use of dietary supplements, and other similar interventions, are promising for the prevention, management, and recovery of COVID-19 patients, it is important to highlight that strong data from randomized clinical trials are needed to support any such assumption. Considering this particular scenario, we present a literature review addressing several important aspects related to diet and SARS-CoV-2 infection, in order to highlight the importance of diet and supplementation in prevention and management of, as well as recovery from COVID-19.

scholarly journals Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

2020 ◽  
Vol 41 (1) ◽  
pp. 9-20
Author(s):  
Louise B. Russell ◽  
Laurie A. Norton ◽  
David Pagnotti ◽  
Christianne Sevinc ◽  
Sophia Anderson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Financial Incentives ◽  
Behavioral Interventions ◽  
Randomized Clinical Trials ◽  
Financial Incentive ◽  
Trial Data ◽  
Control Group ◽  
Cost Information ◽  
Billing Data ◽  
Pragmatic Clinical Trials

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

scholarly journals Role of Omega-3 Fatty Acids in the Treatment of Depressive Disorders: A Comprehensive Meta-Analysis of Randomized Clinical Trials

PLoS ONE ◽  
2014 ◽  
Vol 9 (5) ◽  
pp. e96905 ◽  
Author(s):  
Giuseppe Grosso ◽  
Andrzej Pajak ◽  
Stefano Marventano ◽  
Sabrina Castellano ◽  
Fabio Galvano ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Clinical Trials ◽  
Depressive Disorders ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Omega 3 Fatty Acids ◽  
Omega 3

Role of radiofrequency ablation in the treatment of liver metastases from colorectal cancer: Pooled analysis of randomized clinical trials.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. e14557-e14557
Author(s):  
Fabrizio Drudi ◽  
Emiliano Tamburini ◽  
Manuela Fantini ◽  
Antonio Polselli ◽  
Lucia Stocchi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Radiofrequency Ablation ◽  
Liver Metastases ◽  
Randomized Clinical Trials ◽  
Pooled Analysis

scholarly journals Role of nab-paclitaxel in metastatic breast cancer: a meta-analysis of randomized clinical trials

Oncotarget ◽  
2017 ◽  
Vol 8 (42) ◽  
pp. 72950-72958 ◽  
Author(s):  
Yun Liu ◽  
Guoxin Ye ◽  
Dali Yan ◽  
Lei Zhang ◽  
Fan Fan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Metastatic Breast

scholarly journals Anemia in Chronic Kidney Disease : Role of Hypoxia Inducible Factor Stabilizer

2021 ◽  
Vol 5 (3) ◽  
pp. 395-400
Author(s):  
Emilia ◽  
Zulkhair Ali
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Hypoxia Inducible Factor ◽  
Iron Availability ◽  
Current Standard ◽  
Erythropoietin Production ◽  
Significant Harm ◽  
Erythropoietin Deficiency

A B S T R A C TAnemia contributes to increased morbidity and mortality in chronic kidney diseasepatients. The pathogenesis of anemia in these patients is multifactorial, but thecontribution of erythropoietin deficiency becomes greater as glomerular filtrationrate declines which related to decreased nephron mass. The current standard ofcare includes supplemental iron, erythropoiesis-stimulating agents (ESA), and redblood cell transfusions, although each has drawbacks. Lately, concern has arisenfollowing randomized clinical trials showing that higher hemoglobin targets and/orhigh ESA doses may cause significant harm including increasing cardiovascular andthrombotic events, and even death. Recent experimental and clinical studies showthe promising efficacy of hypoxia inducible factor (HIF) stabilizer which stimulatesendogenous erythropoietin production and enhance iron availability.

scholarly journals A partial defense of clinical equipoise

2019 ◽  
Vol 15 (2) ◽  
pp. 1-17
Author(s):  
Scott D Gelfand
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Clinical Equipoise ◽  
Best Interest ◽  
Fourth Section ◽  
Insight Into ◽  
Shed Light

In this essay, I suggest that a slightly modified version of Freedman’s formulation of the clinical equipoise requirement is justified. I begin this essay with a brief discussion of the equipoise requirement. In the second and third sections, I discuss several objections to the clinical equipoise requirement as well as two attempts to justify the equipoise requirement. In the fourth section, in order to gain some insight into what it means to say that a physician has an obligation to act in the best interest of her patient, I examine a similar obligation, namely, a parent’s obligation to act in her child’s best interest. I claim that there are several uncontroversial exceptions to this obligation, and these exceptions arise when a parent occupies a role more complex than the role of parent simpliciter. In the fifth section, I explore whether the exceptions to a parent’s obligation to act in her child’s best interest may shed light on some exceptions to a physician–researcher’s obligation to act in the best interest of her patient. These exceptions, I suggest, arise when a physician occupies a role more complex than physician simpliciter, and they ground a permission to conduct randomized clinical trials, even if doing so is not in the best interest of a physician–researcher’s patients. I furthermore claim that these exceptions provide justification for a modified formulation of the clinical equipoise requirement.

Chemotherapy in metastatic hormone-naïve prostate cancer: Pooled analysis of randomized clinical trials.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 259-259 ◽  
Author(s):  
Paolo Fabbri ◽  
Lucia Stocchi ◽  
Stefania Nicoletti ◽  
Fabrizio Drudi ◽  
Emiliano Tamburini ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Preliminary Analysis ◽  
Randomized Clinical Trials ◽  
Pooled Analysis ◽  
Hazard Ratio ◽  
Androgen Blockade

259 Background: To assess the role of chemotherapy in metastatic, hormone-naïve prostate cancer, we presents the preliminary data of a pooled analysis comparing the outcome of patients with metastatic hormone-naïve prostate cancer. Methods: A pooled analysis of the outcome of randomized clinical trials approaching the role of docetaxel in metastatic hormone-naïve prostate cancer was performed using a random effect model. The final outcome of all the patients enrolled into the trials was the primary end point of our analysis. The pooled final result was reported as pooled Hazard Ratio and 95% Confidence Interval. The between-the trials heterogeneity was assessed using the I2 test. An α-error of 5% was identified as index of statistical significance. Overall survival of the entire population enrolled into the trials was the outcome of the preliminary analysis, while no subgroup analysis was performed in this preliminary phase of a multi-steps analysis. Results: Three trials (the CHAARTED, the STAMPEDE and the GETUG-AFU 15 trial) were considered eligible and included into the analysis. A pooled Hazard Ratio of 0.76 (95% Confidence Interval of 0.59-0.98, p = 0.037) was detected for overall survival, with an I2 of 67.8. The pooled datum was obtained observed the outcome of 951 patients treated with docetaxel plus androgen blockade and 1338 with androgen blockade alone. Conclusions: Although the between-the-trials heterogeneity seems to suggest caution in the final interpretation of the results, a significant reduction of the risk of death can be obtained with docetaxel in the treatment of metastatic hormone-naïve prostate cancer. Our preliminary analysis, including all the patients with metastatic hormone-naïve prostate cancer, seems to suggest a role of docetaxel in all the patients with metastatic disease; further data are probably needed to detect its role in some different subclasses of patients (patients with high burden of the disease, fit or unfit patients, elderly patients).

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