scholarly journals An ethics framework for consolidating and prioritizing COVID-19 clinical trials

2021 ◽  
Vol 18 (2) ◽  
pp. 226-233
Author(s):  
Michelle N Meyer ◽  
Luke Gelinas ◽  
Barbara E Bierer ◽  
Sara Chandros Hull ◽  
Steven Joffe ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Good News ◽  
Research Review ◽  
Research Institutions ◽  
Short Supply ◽  
Ethics Framework ◽  
Research Prioritization ◽  
Effective Interventions ◽  
Third Stage ◽  
Threshold Criteria

Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.

scholarly journals Systemic sclerosis phase III clinical trials: Hope on the horizon?

2018 ◽  
Vol 3 (3) ◽  
pp. 193-200 ◽  
Author(s):  
Martin Aringer ◽  
Christopher P Denton
Keyword(s):  
Clinical Trials ◽  
Systemic Sclerosis ◽  
Cannabinoid Receptor ◽  
Good News ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Cell Antibody ◽  
Interleukin 6 Receptor ◽  
Low Incidence ◽  
First Time

While significant progress has been made in treating systemic sclerosis, many patients still have an outcome that is far from satisfactory. For the first time in history, several drugs are now in phase III randomized controlled trials. Approaches tested include the anti-B cell antibody rituximab, the anti-interleukin-6 receptor antibody tocilizumab, the antifibrotic drugs nintedanib and pirfenidone, and the cannabinoid receptor mimetic lenabasum. That all these drugs are in advanced clinical trials despite the relatively low incidence of the disease therefore is good news. Not only is there realistic hope that at least some of the approaches will work, this also indicates growing industry interest, for most of the trials are company-sponsored. This review attempts to delineate the ongoing trials and to summarize the underlying evidence of these candidate systemic sclerosis drugs.

scholarly journals The challenges of control groups, placebos and blinding in clinical trials of dietary interventions

2017 ◽  
Vol 76 (3) ◽  
pp. 203-212 ◽  
Author(s):  
Heidi M. Staudacher ◽  
Peter M. Irving ◽  
Miranda C. E. Lomer ◽  
Kevin Whelan
Keyword(s):  
Clinical Trials ◽  
Dietary Intervention ◽  
Research Review ◽  
Dietary Advice ◽  
Dietary Interventions ◽  
Advantages And Disadvantages ◽  
Sham Intervention ◽  
Potential Risks ◽  
Intervention Trials

High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.

scholarly journals Report on a Delphi process and workshop to improve accrual to cancer clinical trials

2016 ◽  
Vol 23 (2) ◽  
pp. 125 ◽  
Author(s):  
J.A.H. Bell ◽  
L.G. Balneaves ◽  
M.T. Kelly ◽  
H. Richardson
Keyword(s):  
Clinical Trials ◽  
Present Report ◽  
Knowledge Exchange ◽  
Evidence Based ◽  
Cancer Clinical Trials ◽  
Research Collaborations ◽  
Effective Interventions ◽  
Key Stakeholders ◽  
Cancer Trials ◽  
Living With Cancer

Cancer clinical trials (ccts) are essential for furthering knowledge and developing effective interventions to improve the lives of people living with cancer in Canada. Randomized controlled trials are particularly important for developing evidence-based health care interventions. To produce robust and relevant research conclusions, timely and sufficient accrual to ccts is essential.The present report delivers the key recommendations emerging from a workshop meeting, Improve Accrual to Cancer Clinical Trials, that was hosted by the Canadian Cancer Trials Group and funded by the Canadian Institutes of Health Research. The meeting, which took place in Toronto, Ontario, in April 2012 before the Canadian Cancer Trials Group annual spring meeting, brought together key stakeholders from across Canada to explore creative strategies for improving accrual to ccts. The objectives of the workshop were to provide an opportunity for knowledge exchange with respect to the research evidence and the ethics theory related to cct accrual and to promote discussion of best practices and policies related to enhancing cct access and accrual in Canada.The workshop provided the foundation for establishing new interdisciplinary research collaborations to overcome the identified barriers to cct participation in Canada. Meeting participants also supported the development of evidence-based policies and practices to make trials more accessible to Canadians living with cancer.

A Role of Clinical Trial in Management of Hypertension and Medication of Hypertension

2021 ◽  
pp. 3215-3222
Author(s):  
Minesh Patel ◽  
G.S. Chakraborthy
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Left Ventricle ◽  
New Drugs ◽  
Research Review ◽  
Incremental Growth ◽  
Indian Food ◽  
New Treatments

Clinical trials are essence for the progress of new treatments. Whether a person should engage confide in on their compassionate of the liability and gain for themselves and for society as an entity. Clinical trials are research review in which people volunteer to attempt major treatments, interventions or experiment as a means to forbid, detect, evaluate or manage assorted diseases or medical conditions. Some investigations glance at how people react to a new arbitration and what side effects valor occur. Every new medicine and treatment initiated with volunteers engage in clinical trials. We incur our present high ideal of medical care to studies that have been operate in the past under guidance of the INDIAN Food and Drug Administration (FDA). In addition to Research on new drugs and devices, clinical trials bring a scientific footing for urge and treating patients. Even when researchers do not achieve the conclusion they anticipate; trial results can help point scientists in the mend direction. Blood pressure is great because the larger than your blood pressure is, the larger than your risk of health problems in the future. If your blood pressure is higher than it is putting extra ache on your arteries and on your heart. High blood pressure clouts your heart to work higher to pump blood to the comfort of your body. This causes part of your heart (left ventricle) to congeal. A congeal left ventricle high your risk of heart attack, heart failure and sudden cardiac death. Heart failure. The arena for clinical trials of hypertension management is in transition. The stage of mega trials may not be bygone but is assuredly in decline. Incremental growth in the therapies assessable in the face of a high global disease hardship has imply that hypertension researchers have also attract on getting beat efficacy and value from the available treatments through arrangement improvement, combinations, and algorithms. There has been go on amuse in the role of nonpharmacological compute in cure and management of hypertension.

Evaluation of observational and controlled trials of therapy

2009 ◽  
pp. 127-152 ◽  
Author(s):  
Richard J. Glassock ◽  
Daniel C. Cattran
Keyword(s):  
Clinical Trials ◽  
False Negative ◽  
Evidence Base ◽  
Glomerular Disease ◽  
Good News ◽  
Specific Disease ◽  
Negative Results ◽  
Primary Glomerular Disease ◽  
Therapeutic Decision Making ◽  
Meta Analyses

The literature on the subject of treatment of glomerular disease is immense (over 15,000 articles in PubMed as of July, 2008). Negotiating this broad and complex panorama can be a difficult task, especially in relationship to the evaluation of the best evidence for a particular treatment strategy for a specific disease entity occurring in an individual patient. Perfection is not attainable in clinical trials of therapy and every report has some pitfall or limitation. Some studies, however, stand out as excellent examples of design and execution. Unfortunately, in the field of treatment of glomerular disease such studies are relatively uncommon. The good news is that well designed and executed studies of treatment of primary glomerular disease are being reported with increasing frequency in recent years. This has occurred in part because of increased collaboration among groups interested in furthering knowledge in this important area of inquiry, but also because of better recognition of the deficiencies of past efforts to study treatment of glomerular disease in clinical trials. Many interinstitutional collaborative studies have been aided by improvements in trial design and by more complete descriptions of the natural history of untreated disease. One of the main weaknesses of clinical studies of therapy in primary glomerular disease is the small numbers of subjects studied in individual reports. This increases the risks of confounding and of both false positive and false negative results. The purpose of this chapter is to provide a concise analysis of the strengths and weakness of the various approaches to the study of therapeutic efficacy and safety of agents used in primary glomerular disease. The focus will be on observational studies, controlled clinical trials, and meta-analyses of published reports. The specific aims are to equip the discerning reader for improved understanding of the evidence-base for therapy of primary glomerular disease. The details of the specific reports and how they can be integrated into an ‘evidence-based’ approach to therapeutic decision-making are dealt with in the chapters devoted to specific disease entities which follow.

scholarly journals Evaluation of the efficacy of low concentration fluoride gel using custom trays to prevent radiation-related dental caries in patients with head and neck cancer: protocol for a randomised controlled phase III trial (FluCar study)

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e038606
Author(s):  
Soutome Sakiko ◽  
Souichi Yanamoto ◽  
Maho Murata ◽  
Yumiko Kawashita ◽  
Masako Yoshimatsu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Head And Neck Cancer ◽  
Dental Caries ◽  
Head And Neck ◽  
Neck Cancer ◽  
Phase Iii ◽  
Research Review ◽  
Control Group ◽  
Type I ◽  
Low Concentration

IntroductionThe present study is a randomised, multicentre, open-label, phase III study, to evaluate the efficacy of low concentration of fluoride gel, applied using custom trays, in preventing radiation-related dental caries in patients with head and neck cancer who have undergone or are undergoing radiotherapy.Methods and analysisPatients will be randomised into fluoride and control groups (1:1 ratio). In the fluoride group, patients will wear custom trays loaded with 0.145% fluoride gel after brushing every night while sleeping. In the control group, patients will receive oral hygiene instructions as usual. Patients in both the groups will be followed up every 3 months for 1 year. The primary endpoint is the incidence of newly developed dental caries. Target accrual is 80 patients with a two-sided type I error rate of 5% and 80% power to detect 80% risk reduction.Ethics and disseminationThis study was approved by the Clinical Research Review Board in Nagasaki University The protocol of this study was registered at Japan Registry of Clinical Trials (jRCT) and University hospital Medical Information Network Clinical Trials Registry (UMIN). The datasets generated during the current study will be available from the corresponding author on reasonable request.Trial registration numbersjRCTs 072190039 and UMIN000041426

scholarly journals Narzędzia szacowania ryzyka powrotu do przestępstwa. Niezbędny instrument postępowania wykonawczego

2020 ◽  
Vol 54 ◽  
pp. 45-65
Author(s):  
Tomasz Kalisz
Keyword(s):  
Clinical Trials ◽  
Criminal Behavior ◽  
Sexual Preference ◽  
Social Reintegration ◽  
Effective Interventions ◽  
Actuarial Methods ◽  
Permanent Form ◽  
Level Of Risk

The aim of the study is to discuss the most important problems related to the assess-ment of the level of risk of recidivism, taking into account actuarial methods, psycho-metric methods, and idiographic clinical trials. The point is to show tools that are intended not only to predict criminal behavior, but also to be an indicator of effective interventions aimed at social reintegration of convicts and thus a permanent form of preventing recid-ivism. These instruments are of particular importance for controlling crimes committed under the influence of sexual preference disorders.

scholarly journals Efficacy of clarithromycin on COVID-19 pneumonia without oxygen administration; protocol for multicenter, open-label, randomized-controlled, 3-armed parallel group comparison, exploratory trial (CAME COVID study)

2021 ◽  
Author(s):  
Kazuko Yamamoto ◽  
Naoki Hosogaya ◽  
Noriho Sakamoto ◽  
Haruo Yoshida ◽  
Hiroshi Ishii ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Symptoms ◽  
The Body ◽  
Research Review ◽  
Group Comparison ◽  
Open Label ◽  
Randomized Controlled ◽  
Exploratory Trial ◽  
Oxygen Administration ◽  
Parallel Group

Introduction: The coronavirus disease 2019 (COVID-19) epidemic has been emerged worldwide. Although several medications have been approved for treating moderate-to-severe COVID-19, no treatment strategy has been established for mild COVID-19 patients who do not require oxygen administration. The spread of SARS-CoV-2 has been mostly through patients with mild COVID-19; therefore, treating patients with mild COVID-19 is critical in society. Clarithromycin is a macrolide antimicrobial agent that has been widely used for bacterial respiratory infectious diseases. Clarithromycin also acts an immunomodulating drug and suppresses cytokine storms in viral respiratory diseases, including influenza infection. In this study, we aimed to evaluate the efficacy of clarithromycin in patients with mild COVID-19. Methods and analysis: This is a multicenter, open-label, randomized controlled, 3-armed parallel group comparison, exploratory trial. Subjects with mild COVID-19 pneumonia who did not require oxygen administration were enrolled and randomly assigned in a 1:1:1 ratio to Group A (administration of clarithromycin 800 mg/day), Group B (administration of clarithromycin 400 mg/day), or Group C (standard treatment without clarithromycin). The primary endpoint was the number of days required to improve clinical symptoms as measured by the severity score. Secondary endpoints included days to recover the body temperature, proportion of subjects with oxygen administration, inflammatory cytokines, viral load, serum immunoglobulins, peripheral blood lymphocytes, blood biomarkers, and pneumonia infiltrations. Ethics and dissemination: The study protocol was approved by the Clinical Research Review Board of Nagasaki University in accordance with the Clinical Trials Act in Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act, and other current legal regulations in Japan. Written informed consent will be obtained from all participants. The results of this study will be reported as journal publications. Registration: This study was registered at the Japan Registry of Clinical Trials (registration number: jRCTs071210011).

scholarly journals Bibliometric analysis on randomized controlled trials of colorectal cancer over the last decade

2020 ◽  
Author(s):  
Jun-hong Hu ◽  
Chen-Yu Wang ◽  
Shi-Can Zhou ◽  
Xing-Wang Li ◽  
Bing-Hui Li ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Clinical Research ◽  
Randomized Controlled Trials ◽  
Bibliometric Analysis ◽  
Controlled Trials ◽  
Research Institutions ◽  
Randomized Controlled ◽  
The Past ◽  
Surgical Methods

Abstract Background The aim of this bibliometric analysis was to evaluate the clinical trials of randomized controlled trials (RCTs) of colorectal cancer all the world over the past decade. Methods The PubMed and Web of Science database were searched to obtain a randomized controlled trial of colorectal cancer from January 1, 2008 to January 1, 2018.The included literatures were analyzed with the bibliometric analysis. Results In the past 10 years, Randomized controlled trials of colorectal cancer have shown an upward trend; Most of the top ten research institutions in the literature are from the USA, the UK and other regions which has the high incidence of colorectal cancer; Most of the related research journals are also sponsored by European and American countries; the frequently cited top 15 literatures are mostly international multi-center clinical research, and there are fewer participants in Chinese research institutions. By keyword co-occurrence, colorectal cancer research mostly involves screening, disease-free survival, drug treatment, surgical methods, clinical trials, quality of life and prognosis; The results of the co-authorship network analysis show that Chinese researchers are less involved in international cooperation. Conclusions High-quality randomized controlled trials are increasingly favored by top international journals. However, there is still a large gap in clinical research between China and abroad. Researchers should gradually implement the standardization and accuracy of clinical trials, strengthen international multi-center cooperation and emphasize quality control.

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