scholarly journals How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis

Bioanalysis ◽  
2021 ◽  
Author(s):  
Melanie Anderson
Keyword(s):  
Clinical Trial ◽  
Long Term Effects ◽  
Sample Collection ◽  
Trial Conduct ◽  
Device Development ◽  
New Methods ◽  
Traditional Approaches ◽  
Clinical Trial Conduct ◽  
Research Resources

Thousands of clinical trials all over the world were stopped, disrupted or delayed while countries grappled to contain the pandemic and research resources were redeployed. The long-term effects of the turbulence caused by the pandemic have yet to be fully understood, but it should already be clear that the increased focus on participant needs and on the logistical challenges of current models are not likely to fade away quickly. This disruption is opening doors for rethinking traditional approaches to clinical trial conduct – including decentralizing site visits, introducing new methods of sample collection, rethinking matrix selection, reducing sample volumes and collaborating on device development. These approaches reduce participant burden while improving critical trial data.

International Standards for Clinical Trial Conduct and Reporting

2003 ◽  
Vol 82 (6) ◽  
pp. 415-416 ◽  
Author(s):  
Richard Niederman ◽  
Derek Richards ◽  
Debora Matthews ◽  
Daniel Shugars ◽  
Helen Worthington ◽  
...  
Keyword(s):  
Clinical Trial ◽  
International Standards ◽  
Trial Conduct ◽  
Clinical Trial Conduct

The Immediate And Long-Term Effects of Shexiang Tongxin Dropping Pill On Coronary Slow Flow: Study Protocol For A Randomized Double-Blind Placebo-Controlled Trial

2021 ◽  
Author(s):  
Birong Liu ◽  
Yong Liu ◽  
Liyong Ma ◽  
Jia Liu ◽  
Jingen Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Blood Flow ◽  
Blood Stasis ◽  
Blood Stasis Syndrome ◽  
Controlled Study ◽  
Slow Flow ◽  
Long Term Effects ◽  
Coagulation Function ◽  
Coronary Slow Flow

Abstract Background: Coronary slow flow (CSF) is a phenomenon characterized by delayed contrast medium progression in angiography in the absence of obstructive coronary epicardial disease. However, there is currently no definite effective therapy. A small sample self-controlled study had suggested an immediate improvement in coronary slow blood flow by Shexiang Tongxin Dropping Pills (STDP). But high-quality evidences on drug dosage, medication cycle and long-term effects are still lacking while the mechanism of STDP remains unclear. Methods: This study is a randomized, double-blinded, and placebo-controlled clinical trial. A total of 64 CSF patients diagnosed by coronary angiography will be randomly allocated into the test group, using STDP, and the control group, using placebo. The main efficacy indicators for immediate effects include thrombolysis in myocardial infarction (TIMI) blood flow grading and corrected TIMI frame count. Long-term effects will be evaluated by the comparison of cardiac radionuclide score, and patient condition such as angina readmission rate and angina scale. The safety indicators include a routine complete blood count, liver and renal function test, cardiac markers (including TnI, CK-MB, Myo), NT-proBNP, coagulation function, 12-lead electrocardiogram, and echocardiography. All adverse events during the trial will be recorded. Moreover, endothelial factors (including ET-1, NO, eNOS, iNOS), inflammatory factors (including adropin, IL-6, IL-1, IL-18, TNF-α, Lp-PLA2, hs-CRP) will be observed. Blood stasis syndrome (including platelet activation factors such as CD62 and CD63, coagulation function and blood stasis syndrome score) will be evaluated.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000035167. Registered on August 2, 2020. http://www.chictr.org.cn/showproj.aspx?proj=57349

scholarly journals Short- and long-term effects of exercise on neck muscle function in cervical radiculopathy: A randomized clinical trial

2016 ◽  
Vol 25 ◽  
pp. e72
Author(s):  
M. Halvorsen ◽  
D. Falla ◽  
L. Gizzi ◽  
K. Harms-Ringdahl ◽  
A. Peolsson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Muscle Function ◽  
Cervical Radiculopathy ◽  
Neck Muscle ◽  
Long Term Effects ◽  
Short And Long Term

scholarly journals Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017246 ◽  
Author(s):  
Samuel R P Franzen ◽  
Clare Chandler ◽  
Sisira Siribaddana ◽  
Julius Atashili ◽  
Brian Angus ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Necessary Conditions ◽  
Evidence Based ◽  
Middle Income ◽  
Trial Conduct ◽  
Middle Income Countries ◽  
Barriers And Enablers ◽  
Research Systems ◽  
Clinical Trial Conduct

ObjectivesIn 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.DesignProspective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).SettingCase studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100).Primary and secondary outcome measuresDiscussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.ResultsInstitutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.ConclusionsBarriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

scholarly journals LONG-TERM EFFECTS OF EPIRUBICIN ON INCIDENCE OF HEART FAILURE IN WOMEN WITH BREAST CANCER: DATA FROM A RANDOMIZED CLINICAL TRIAL

2016 ◽  
Vol 67 (13) ◽  
pp. 1513
Author(s):  
Ann Bøcher Secher Banke ◽  
Emil Fosbol ◽  
Jacob Møller ◽  
Gunnar Gislason ◽  
Mads Andersen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Heart Failure ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Breast Cancer Data ◽  
Long Term Effects ◽  
Cancer Data

scholarly journals Effects of Including Information about Hidden Hearing Loss in an Adopt-A-Band Program on College Band Members' Attitudes toward Healthy Hearing Behaviors

2018 ◽  
Vol 39 (02) ◽  
pp. 210-220 ◽  
Author(s):  
Carole Johnson ◽  
Jonathan Baldwin ◽  
Jeffrey Danhauer ◽  
Brian Wolfe ◽  
Stevana Jeannont ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hearing Loss ◽  
Confidence Interval ◽  
Self Efficacy ◽  
Future Research ◽  
Long Term Effects ◽  
Marching Bands ◽  
Hidden Hearing Loss ◽  
College Band

AbstractYoung musicians may be at risk for developing cochlear synaptopathy (CS), or hidden hearing loss (HHL), that could lead to permanent music-induced hearing loss (MIHL). Patients with CS often complain of tinnitus and/or difficulty understanding speech in noisy situations, even though traditional audiometric testing indicates normal hearing. The aim of this article was to determine the effects of including information about HHL on an Adopt-A-Band program involving college band members' concern about and self-efficacy toward the prevention of MIHL. We conducted a single-blinded, randomized clinical trial. Forty-eight band members participated in this study. Band members were randomly assigned to two Adopt-A-Band presentations, one with and one without information on HHL. Including information about HHL had no effect on these band members' concerns about and self-efficacy toward the prevention of MIHL. However, the Adopt-A-Band program resulted in significantly increased concern for MIHL by 39.5% (p < 0.0001, 95% confidence interval [CI]: 25–54.2), self-efficacy in its prevention by 79.1% (p < 0.0001, 95% CI: 66.9–91.2), and plans to use musicians' earplugs while playing by 67.4% (p < 0.0001, 95% CI: 53.4–81.45). Although inclusion of information about HHL did not have a significant effect, the Adopt-A-Band program, in general, significantly increased the immediate intent of these students to practice healthy hearing behaviors. Future research is needed to determine the long-term effects of using the Adopt-A-Band program with university marching bands' use of healthy hearing behaviors.

Neurotrophic approach in preventive therapy of alzheimer disease

2011 ◽  
Vol 26 (S2) ◽  
pp. 488-488
Author(s):  
S. Gavrilova ◽  
I. Kolykhalov ◽  
Y. Fedorova ◽  
M. Odinak ◽  
A. Emelin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alzheimer Disease ◽  
Cognitive Deficit ◽  
Diagnostic Category ◽  
Preventive Therapy ◽  
Long Term Effects ◽  
Clinical Scales ◽  
Slowing Down ◽  
Ad Therapy

IntroductionDuring the last years a great number of new facts of involving nerve growth factors (NGF) in pathogenesis of Alzheimer Disease (AD) and other neurodegenerative diseases have been received. Discovery of neurotrophic effects of Cerebrolysin similar to NGF attracted new attention to it (Rockenstein E. et al. 2000).Clinical study of long-term effects of Cerebrolysin has proved that Cerebrolysin has positive modifying action on the dementia progression (Gavrilova S.I. et al., 2003). That's why we suggest that Cerebrolysin may prevent or slow down clinical manifestation of dementia in patients with mild cognitive impairment (MCI) of amnestic type.The aim of the present study was to investigate in an open comparative prospective clinical trial ability of Cerebrolysin to slow down or prevent transition of MCI syndrome into the clinically evident AD in 2 groups of patients repeatedly treated with 1 month courses of Cerebrolysin or Cavinton during a period of 3 years.Methods110 patients who met the diagnostic criteria of MCI of amnestic typewere included. During the clinical trial patients were assessed with a set of clinical scales and a battery of neuropsychological cognitive tests. Genotyping for the APOE polymorphism was performed as well.ResultsThe superiority of Cerebrolysin over Cavinton in slowing down of the cognitive deficit progression and delaying the time or transition of MCI patients to the diagnostic category of Alzheimer disease during 3 years was demonstrated. Cerebrolysin was particularly effective in MCI patients with the ApoE4 (+) genotype.ConclusionCerebrolysin could be recommended as a preventive AD therapy.

scholarly journals Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

2020 ◽  
Author(s):  
Eudocia Q Lee ◽  
Michael Weller ◽  
Joohee Sul ◽  
Stephen J Bagley ◽  
Solmaz Sahebjam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Response Assessment ◽  
Primary Brain Tumor ◽  
Trial Participation ◽  
Cooperative Groups ◽  
Clinical Trial Participation ◽  
Eligibility Criteria ◽  
Trial Conduct ◽  
The Impact ◽  
Clinical Trial Conduct

Abstract Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

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