scholarly journals Aspirin for Primary Prevention in Adults Older than 70 Years is Not Supported by High-Quality Trial Data and May Cause Harm

2020 ◽  
Vol 133 (7) ◽  
pp. e389-e390
Author(s):  
Suzanne E. Mahady ◽  
Robyn L. Woods ◽  
Rory Wolfe ◽  
Mark R. Nelson ◽  
Anne M. Murray ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Trial Data ◽  
High Quality ◽  
Quality Trial ◽  
High Quality Trial

scholarly journals Evidence-Based Guidelines Should Be Used to Inform COVID-19 Management

2020 ◽  
Author(s):  
Thomas L. Holland
Keyword(s):  
Treatment Algorithm ◽  
Trial Data ◽  
Evidence Based ◽  
High Quality ◽  
Recent Commentary ◽  
Quality Trial ◽  
High Quality Trial ◽  
Evidence Based Guidelines

A recent commentary by McCullough (1) includes a recommended COVID treatment algorithm that is outdated and parts of which are contradicted by high quality trial data.…

scholarly journals Children Are Not Just Small Adults: The Urgent Need for High-Quality Trial Evidence in Children

PLoS Medicine ◽  
2008 ◽  
Vol 5 (8) ◽  
pp. e172 ◽  
Author(s):  
Terry P Klassen ◽  
Lisa Hartling ◽  
Jonathan C Craig ◽  
Martin Offringa
Keyword(s):  
High Quality ◽  
Quality Trial ◽  
High Quality Trial ◽  
Trial Evidence

scholarly journals Investigation-Based Drug Value Framework in Hodgkin Lymphoma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2262-2262
Author(s):  
Ohad Oren
Keyword(s):  
Clinical Trials ◽  
Hodgkin Lymphoma ◽  
Scoring System ◽  
Conflicts Of Interest ◽  
High Quality ◽  
Nccn Guidelines ◽  
Significant Toxicity ◽  
Anti Cancer ◽  
Quality Trial ◽  
High Quality Trial

Abstract Background Currently available drug value frameworks integrate data about a medication's benefits and risks. However, the strength of the research data supporting the use of one medication versus another is highly variable. The greater the number and quality of well-conducted trials underlying a certain intervention, the stronger its potential favorable contribution to public health. Drug value should therefore also be a function of the magnitude of clinical evidence gleaned from high-quality clinical trials. Methods We propose an investigation-driven value framework that determines the merit of a drug based on the overall available evidence, including the rigour of relevant trials. The NCCN Hodgkin Lymphoma guidelines were reviewed and data collected about commonly used regimens for Classic HL. Value scores were determined for each drug combination. Results A model was designed incorporating information about the number of RCTs conducted, the total number of participants enrolled, and the generalizability to real-world populations, in addition to the drug's efficacy, significant toxicity and cost (Figure 1). Practice-changing trials supporting each of the currently-endorsed regimens were collected from the HL NCCN guidelines (ABVD, 4; Stanford V 4; Esc BEACOPP 2). The average number of participants per trial was higher for ABVD (1,126) and Esc BEACOPP (1,890) than for Stanford V (267). The generalizability score for the three compounds was 0.5 (ABVD), 0.25 (Stanford V) and -1 (Esc BEACOPP). The mean 5-year overall survival rate was higher in the case of ABVD (96.2%) and Esc BEACOPP (96.1%) compared with Stanford V (92.0%). The toxicity score was 1.24 (ABVD), 3 (Stanford V) and 2.5 (Esc BEACOPP). Using a multi-factorial value scoring system, ABVD, Esc BEACOPP and Stanford V obtained 11.5, 9.5 and 8.5 points, respectively. A scoring system that focused on traditional factors alone (efficacy, toxicity, cost) yielded different scores (ABVD, 7.7; Stanford V 6.7; Esc BEACOPP, 6.5). Conclusion The robustness of clinical trials investigating anti-cancer regimens deserves special consideration when defining drug value. Three high-quality trial characteristics help stratify common regimens in HL into higher/lower value strata using a simple, easy to use algorithm. Disclosures No relevant conflicts of interest to declare.

Feynman-Kac path-integral calculations with high-quality trial wave functions

2000 ◽  
Vol 61 (3) ◽  
Author(s):  
Sumita Datta ◽  
J. L. Fry ◽  
N. G. Fazleev ◽  
S. A. Alexander ◽  
R. L. Coldwell
Keyword(s):  
Path Integral ◽  
Wave Functions ◽  
High Quality ◽  
Quality Trial ◽  
High Quality Trial

Maintaining independence in older people

2010 ◽  
Vol 20 (2) ◽  
pp. 128-153 ◽  
Author(s):  
AD Beswick ◽  
R Gooberman-Hill ◽  
A Smith ◽  
V Wylde ◽  
S Ebrahim
Keyword(s):  
Older People ◽  
Social Engagement ◽  
Hospital Admissions ◽  
Meta Analysis ◽  
Functional Decline ◽  
Complex Interventions ◽  
Preventive Strategies ◽  
Health And Social Care ◽  
Quality Trial ◽  
High Quality Trial

SummaryAppropriate social and medical interventions may help maintain independence in older people. Determinants of functional decline, disability and reduced independence are recognized and specific interventions target the treatment of clinical conditions, multiple health problems and geriatric conditions, prevention of falls and fractures, and maintenance of physical and cognitive function and social engagement.Preventive strategies to identify and treat diverse unmet needs of older people have been researched extensively. We reviewed systematically recent randomized controlled trials evaluating these ‘complex’ interventions and incorporated the findings of 21 studies into an established meta-analysis that included 108,838 people in 110 trials. There was an overall benefit of complex interventions in helping older people to live at home, explained by reduced nursing home admissions rather than death rates. Hospital admissions and falls were also reduced in intervention groups. Benefits were largely restricted to earlier studies, perhaps reflecting general improvements in health and social care for older people. The wealth of high-quality trial evidence endorses the value of preventive strategies to help maintain independence in older people.

Statins for primary prevention: what is the regulator’s role?

2020 ◽  
pp. bmjebm-2019-111321 ◽  
Author(s):  
Tom Jefferson ◽  
Maryanne Demasi ◽  
Peter Doshi
Keyword(s):  
Cardiovascular Disease ◽  
Decision Making ◽  
Primary Prevention ◽  
General Public ◽  
Trial Data ◽  
Central Location ◽  
Decision Making Processes ◽  
Drug Approvals ◽  
Prevention Of Cardiovascular Disease

Globally, drug regulators have approved statins for the prevention of cardiovascular disease (CVD), although their use in primary prevention has been controversial. A highly publicised debate has ensued over whether the benefits outweigh the harms. Drug regulators, which are legally required to make independent judgements on drug approvals, have remained silent during the debate. Our aim was to navigate the decision-making processes of European drug regulators and ultimately request the data upon which statins were approved. Our findings revealed a system of fragmented regulation in which many countries licensed statins but did not analyse the data themselves. There is no easily accessible archive containing information about the licensing approval of statins or a central location for holding the trial data. This is an unsustainable model and serves neither the general public, nor researchers.

scholarly journals A Review of Ginseng Clinical Trials Registered in the WHO International Clinical Trials Registry Platform

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Yingchun He ◽  
Juan Yang ◽  
Yinghua Lv ◽  
Junchao Chen ◽  
Fang Yin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Comprehensive Evaluation ◽  
Clinical Settings ◽  
Double Blind ◽  
Funding Sources ◽  
Quality Trial ◽  
High Quality Trial ◽  
Design Type ◽  
Duration Condition ◽  
Clinical Trials Registry

Although ginseng has long been broadly used in clinical settings around the world, few clinical trials on ginseng have been conducted. The objective of this study was to provide a comprehensive evaluation of the characteristics of ginseng clinical trials registered in the WHO International Clinical Trials Registry Platform (ICTRP) as of December 2017 regarding their frequency, design, type of ginseng, dosage, duration, condition, funding sources, and publication status. A total of 134 ginseng clinical studies were registered from 2002 to 2017, of which 60.4% were completed and 23.1% are actively recruiting participants. A large number of trials were associated with aspects of high-quality trial design. Overall, 94% of the trials employed randomized allocation to study arms, 78.4% were double-blind studies using placebo as one of the control groups, and 71% were published as completed trials. Trials whose sample size was restricted to fewer than 100 participants accounted for 74.7% of the total. Of the primary funding sources for ginseng studies, 67.2% were nonindustry organizations. The ginseng clinical trials were heterogeneous with respect to ginseng species and variety, indications, dose, duration, and participant characteristics. Clearly, stricter and methodologically suitable studies are needed to demonstrate the efficacy and safety of ginseng.

scholarly journals TransCelerate: a global collaboration across biopharmaceutical R&D to accelerate and simplify new medi-cines development

2016 ◽  
Vol 1 (1) ◽  
pp. 14
Author(s):  
Lynn Marks
Keyword(s):  
Clinical Trial ◽  
Development Program ◽  
Cost Effective ◽  
Clinical Development ◽  
Non Profit ◽  
Clinical Development Program ◽  
The World ◽  
Aging Populations ◽  
Quality Trial ◽  
High Quality Trial

As the economic pressures increase on healthcare systems around the world due to aging populations, chronic diseases, expanding patient populations in emerging markets and advances in medical technology, it is crucial that we focus on developing and delivering innovative and quality medicines with true medical value to patients around the world in a more collaborative, quality-focused and cost-effective manner.An important component to this mission across the biopharmaceutical industry is identifying and solving common issues that compromise the success of a clinical development program – the shared pathway to safer and more clinically meaningful medicines. However, subject recruitment challenges, data collection and follow-up issues, identification of high-quality trial sites, and lack of successfully achieving study timelines continue to stress clinical trial operations teams across companies. Although there has been progressing across this range of roadblocks by individual companies, the underlying economics continue to threaten the research and development (R&D) business model.Failure to solve these key issues will affect all parties involved in the clinical trial enterprise: patients, clinical inves-tigators, health authorities, academia, tax-payers and the sponsor companies. The question remains whether a deep and broad collaborative effort that stretches across the clinical development arena—one that is charged with a common goal of improving quality, enhancing the investigator and patient experience, reducing costs and sharing data—can be a catalyst for success. With encouraging signs already realised, the operation of TransCelerate BioPharma Inc., a non-profit organisation created to improve the health of people around the world by accelerating and enhancing the R&D of innovative new therapies will test this premise.

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