scholarly journals Position Paper: Recommended Design Features of Future Clinical Trials of Antibacterial Agents for Community‐Acquired Pneumonia

2008 ◽  
Vol 47 (S3) ◽  
pp. S249-S265 ◽  
Author(s):  
Keyword(s):  
Clinical Trials ◽  
Antibacterial Agents ◽  
Community Acquired Pneumonia ◽  
Position Paper ◽  
Design Features

The Programmable Implantable Medication System (PIMS): Design Features and Pre-Clinical Trials

1990 ◽  
Vol 22 (04) ◽  
pp. 201-206 ◽  
Author(s):  
C. Saudek ◽  
R. Fischell ◽  
M. Swindle
Keyword(s):  
Clinical Trials ◽  
Design Features

scholarly journals Canadian Recommendations for Clinical Trials of Pharmacologic Interventions in Rheumatoid Arthritis: Inclusion Criteria and Study Design: Table 1.

2011 ◽  
Vol 38 (10) ◽  
pp. 2095-2104 ◽  
Author(s):  
JACOB KARSH ◽  
EDWARD C. KEYSTONE ◽  
BOULOS HARAOUI ◽  
J. CARTER THORNE ◽  
JANET E. POPE ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Activity ◽  
Study Design ◽  
New Drugs ◽  
Nominal Group ◽  
Consensus Method ◽  
Inclusion Criteria ◽  
Design Features

Objective.Current clinical trial designs for pharmacologic interventions in rheumatoid arthritis (RA) do not reflect the innovations in RA diagnosis, treatment, and care in countries where new drugs are most often used. The objective of this project was to recommend revised entry criteria and other study design features for RA clinical trials.Methods.Recommendations were developed using a modified nominal group consensus method. Canadian Rheumatology Research Consortium (CRRC) members were polled to rank the greatest challenges to clinical trial recruitment in their practices. Initial recommendations were developed by an expert panel of rheumatology trialists and other experts. A scoping study methodology was then used to examine the evidence available to support or refute each initial recommendation. The potential influence of CRRC recommendations on primary outcomes in future trials was examined. Recommendations were finalized using a consensus process.Results.Recommendations for clinical trial inclusion criteria addressed measures of disease activity [Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) > 3.2 PLUS ≥ 3 tender joints using 28-joint count (TJC28) PLUS ≥ 3 swollen joint (SJC28) OR C-reactive protein (CRP) or ESR > upper limit of normal PLUS ≥ 3 TJC28 PLUS ≥ 3 SJC28], functional classification, disease classification and duration, and concomitant RA treatments. Additional recommendations regarding study design addressed rescue strategies and longterm extension.Conclusion.There is an urgent need to modify clinical trial inclusion criteria and other study design features to better reflect the current characteristics of people living with RA in the countries where the new drugs will be used.

scholarly journals Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology

2015 ◽  
Vol 37 (9) ◽  
pp. 747-754 ◽  
Author(s):  
Neville Jackson ◽  
Dan Atar ◽  
Maria Borentain ◽  
Günter Breithardt ◽  
Martin van Eickels ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cardiovascular Diseases ◽  
European Society ◽  
Round Table ◽  
Position Paper ◽  
European Society Of Cardiology

scholarly journals Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

2020 ◽  
Vol 41 (22) ◽  
pp. 2109-2117 ◽  
Author(s):  
Stefan D Anker ◽  
Javed Butler ◽  
Muhammad Shahzeb Khan ◽  
William T Abraham ◽  
Johann Bauersachs ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
European Society ◽  
Clinical Care ◽  
Position Paper ◽  
Adverse Outcomes ◽  
Web Based ◽  
Effective Care ◽  
America South ◽  
European Society Of Cardiology

Abstract The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

scholarly journals Comparative Analysis of Drug Interactions with Antibacterial Agents in the Treatment of Community-Acquired Pneumonia

2021 ◽  
Vol 9 (3) ◽  
pp. 136-143
Author(s):  
A. A. Taube ◽  
M. V. Zhuravleva ◽  
T. V. Alexandrova ◽  
O. A. Demidova ◽  
I. A. Mazerkina
Keyword(s):  
Comparative Analysis ◽  
Drug Interactions ◽  
Antibacterial Agents ◽  
Community Acquired Pneumonia

scholarly journals Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium

2021 ◽  
Vol 74 (1) ◽  
pp. 200-219
Author(s):  
Elsa Solà ◽  
Elisa Pose ◽  
Daniela Campion ◽  
Salvatore Piano ◽  
Olivier Roux ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Position Paper ◽  
Decompensated Cirrhosis
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