scholarly journals Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Janet L. Funk ◽  
Claus Schneider
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Dietary Supplements ◽  
Clinical Trial Design ◽  
The United States ◽  
Lessons Learned ◽  
Disease Treatment ◽  
Botanical Dietary Supplements ◽  
Regulatory Frameworks ◽  
Key Points

Plant-derived compounds, without doubt, can have significant medicinal effects since many notable drugs in use today, such as morphine or taxol, were first isolated from botanical sources. When an isolated and purified phytochemical is developed as a pharmaceutical, the uniformity and appropriate use of the product are well defined. Less clear are the benefits and best use of plant-based dietary supplements or other formulations since these products, unlike traditional drugs, are chemically complex and variable in composition, even if derived from a single plant source. This perspective will summarize key points–including the premise of ethnobotanical and preclinical evidence, pharmacokinetics, metabolism, and safety–inherent and unique to the study of botanical dietary supplements to be considered when planning or evaluating botanical clinical trials. Market forces and regulatory frameworks also affect clinical trial design since in the United States, for example, botanical dietary supplements cannot be marketed for disease treatment and submission of information on safety or efficacy is not required. Specific challenges are thus readily apparent both for consumers comparing available products for purchase, as well as for commercially sponsored vs. independent researchers planning clinical trials to evaluate medicinal effects of botanicals. Turmeric dietary supplements, a top selling botanical in the United States and focus of over 400 clinical trials to date, will be used throughout to illustrate both the promise and pitfalls associated with the clinical evaluation of botanicals.

scholarly journals Are women underrepresented in cerebrovascular disease clinical trials? A systematic review using the FDA database

2020 ◽  
Author(s):  
Xiaobo Zhong ◽  
Qing Hao
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Cerebrovascular Disease ◽  
Meta Analysis ◽  
Regression Tree ◽  
Clinical Trial Design ◽  
Drug Approval ◽  
The United States ◽  
Boosted Regression Tree ◽  
Women's Participation

ABSTRACTBACKGROUND AND PURPOSEClinical trials provide essential evidence in the US Food and Drug Administration (FDA) drug approval process. Women were underrepresented in the enrollment of clinical trials for many medical conditions other than cerebrovascular disease (CVD). We investigated women’s participation in FDA-registered CVD-related interventional clinical trials and assessed whether women CVD patients in the United States were underrepresented. We also evaluated the association between the underrepresentation and the features of design and operation among these trials.METHODSWe systematically reviewed the phase 2 and 3 CVD-related interventional trials started in 2002–2017 in the FDA database. The proportions of women enrolled in these trials and the proportion-to-prevalence ratios (PPRs), defined as the ratios of the proportions of women enrolled in these trials to the proportion of women prevalent among US CVD patients during the same period, were calculated and summarized by a meta-analysis approach. We used boosted regression tree, a machine learning model, to identify the determinants of women’s underrepresentation in CVD-related trials.RESULTSAccording to our selection criteria, we analyzed the data of 145 CVD-related trials, among which 40.9% (95% CI: 38.3–43.5%) of the patients enrolled were women. Their PPR was estimated to be 0.843 (95% CI: 0.796–0.890). We found that four factors substantially influenced women’s underrepresentation in these trials: the number of enrollment sites, the starting year, randomization, and academic institution sponsorship.CONCLUSIONSGenerally, women with CVD in the United States were underrepresented in FDA registered trials started in 2002–2017. In addition, trials with greater numbers of enrollment sites, randomization, and non-academically sponsored trials had a higher risk of underrepresenting women with CVD in the United States. Investigators should take these factors into consideration in clinical trial design in the future, by either increasing women’s participation or stratifying the enrollment by gender.

Developing a Clinical Trials Infrastructure in the United States

2012 ◽  
Vol 2 (5) ◽  
Author(s):  
Paul Eisenberg ◽  
◽  
Petra Kaufmann ◽  
Ellen Sigal ◽  
Janet Woodcock ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States

Winning the Argument and Moving the Fight: The Legacy of a Grassroots Humanitarian

Public Voices ◽  
2016 ◽  
Vol 14 (1) ◽  
pp. 115
Author(s):  
Mary Coleman
Keyword(s):  
Higher Education ◽  
United States ◽  
Winning Strategy ◽  
Supreme Court Decision ◽  
The United States ◽  
Colleges And Universities ◽  
Lessons Learned ◽  
The Political ◽  
Political Actors ◽  
Trade Offs

The author of this article argues that the two-decades-long litigation struggle was necessary to push the political actors in Mississippi into a more virtuous than vicious legal/political negotiation. The second and related argument, however, is that neither the 1992 United States Supreme Court decision in Fordice nor the negotiation provided an adequate riposte to plaintiffs’ claims. The author shows that their chief counsel for the first phase of the litigation wanted equality of opportunity for historically black colleges and universities (HBCUs), as did the plaintiffs. In the course of explicating the role of a legal grass-roots humanitarian, Coleman suggests lessons learned and trade-offs from that case/negotiation, describing the tradeoffs as part of the political vestiges of legal racism in black public higher education and the need to move HBCUs to a higher level of opportunity at a critical juncture in the life of tuition-dependent colleges and universities in the United States. Throughout the essay the following questions pose themselves: In thinking about the Road to Fordice and to political settlement, would the Justice Department lawyers and the plaintiffs’ lawyers connect at the point of their shared strength? Would the timing of the settlement benefit the plaintiffs and/or the State? Could plaintiffs’ lawyers hold together for the length of the case and move each piece of the case forward in a winning strategy? Who were plaintiffs’ opponents and what was their strategy? With these questions in mind, the author offers an analysis of how the campaign— political/legal arguments and political/legal remedies to remove the vestiges of de jure segregation in higher education—unfolded in Mississippi, with special emphasis on the initiating lawyer in Ayers v. Waller and Fordice, Isaiah Madison

scholarly journals 690 Are participants in obstetrical randomized clinical trials representative of the United States pregnant population?

2021 ◽  
Vol 224 (2) ◽  
pp. S433
Author(s):  
Cynthia Coots ◽  
Stephen Wagner ◽  
Matthew J. Bicocca ◽  
Megha Gupta ◽  
Hector Mendez Figueroa ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
The United States

scholarly journals Preparedness and response to an emerging health threat—Lessons learned from Candida auris outbreaks in the United States

2021 ◽  
pp. 1-6
Author(s):  
Diane Meyer ◽  
Elena K. Martin ◽  
Syra Madad ◽  
Priya Dhagat ◽  
Jennifer B. Nuzzo
Keyword(s):  
United States ◽  
New York ◽  
Qualitative Interviews ◽  
The United States ◽  
Lessons Learned ◽  
Infection Prevention And Control ◽  
Healthcare Organizations ◽  
Candida Auris ◽  
Term Care ◽  
Healthcare Facilities

Abstract Objective: Candida auris infections continue to occur across the United States and abroad, and healthcare facilities that care for vulnerable populations must improve their readiness to respond to this emerging organism. We aimed to identify and better understand challenges faced and lessons learned by those healthcare facilities who have experienced C. auris cases and outbreaks to better prepare those who have yet to experience or respond to this pathogen. Design: Semi-structured qualitative interviews. Setting: Health departments, long-term care facilities, acute-care hospitals, and healthcare organizations in New York, Illinois, and California. Participants: Infectious disease physicians and nurses, clinical and environmental services, hospital leadership, hospital epidemiology, infection preventionists, emergency management, and laboratory scientists who had experiences either preparing for or responding to C. auris cases or outbreaks. Methods: In total, 25 interviews were conducted with 84 participants. Interviews were coded using NVivo qualitative coding software by 2 separate researchers. Emergent themes were then iteratively discussed among the research team. Results: Key themes included surveillance and laboratory capacity, inter- and intrafacility communication, infection prevention and control, environmental cleaning and disinfection, clinical management of cases, and media concerns and stigma. Conclusions: Many of the operational challenges noted in this research are not unique to C. auris, and the ways in which we address future outbreaks should be informed by previous experiences and lessons learned, including the recent outbreaks of C. auris in the United States.

scholarly journals EPID-07. ACCESS TO GLIOBLASTOMA CLINICAL TRIALS FOR RURAL PATIENTS IN THE UNITED STATES FROM 2010–2020

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii79-ii79
Author(s):  
Kathryn Nevel ◽  
Samuel Capouch ◽  
Lisa Arnold ◽  
Katherine Peters ◽  
Nimish Mohile ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Rural Communities ◽  
The United States ◽  
Interventional Treatment ◽  
Phase Ii Trials ◽  
Treatment Trials ◽  
Rural Sites ◽  
Rural Patients ◽  
Urban Sites

Abstract BACKGROUND Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. METHODS We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. RESULTS We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p< 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. DISCUSSION Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.

scholarly journals Evolving oxygenation management reasoning in COVID-19

Diagnosis ◽  
2020 ◽  
Vol 7 (4) ◽  
pp. 381-383
Author(s):  
Steven Liu ◽  
Cara Sweeney ◽  
Nalinee Srisarajivakul-Klein ◽  
Amanda Klinger ◽  
Irina Dimitrova ◽  
...  
Keyword(s):  
United States ◽  
Intensive Care Unit ◽  
New York ◽  
New York City ◽  
Intensive Care ◽  
Initial Phase ◽  
The United States ◽  
Lessons Learned ◽  
Hypoxemic Respiratory Failure ◽  
Hospital Wards

AbstractThe initial phase of the SARS-CoV-2 pandemic in the United States saw rapidly-rising patient volumes along with shortages in personnel, equipment, and intensive care unit (ICU) beds across many New York City hospitals. As our hospital wards quickly filled with unstable, hypoxemic patients, our hospitalist group was forced to fundamentally rethink the way we triaged and managed cases of hypoxemic respiratory failure. Here, we describe the oxygenation protocol we developed and implemented in response to changing norms for acuity on inpatient wards. By reflecting on lessons learned, we re-evaluate the applicability of these oxygenation strategies in the evolving pandemic. We hope to impart to other providers the insights we gained with the challenges of management reasoning in COVID-19.

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