scholarly journals Expanded Access and Right To Try Requests: The Community Oncologist's Experience

2021 ◽  
pp. OP.20.00569
Author(s):  
Marjorie E. Zettler ◽  
Yolaine Jeune-Smith ◽  
Bruce A. Feinberg ◽  
Eli G. Phillips ◽  
Ajeet Gajra
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Treatment Options ◽  
The United States ◽  
Investigational Drug ◽  
Web Based ◽  
Expanded Access ◽  
Patients With Cancer ◽  
The Us ◽  
The Right

PURPOSE: For patients with cancer who have exhausted approved treatment options and for whom appropriate clinical trials are not available, access to investigational drugs through the US Food and Drug Administration's Expanded Access (EA) program has been an alternative since the program's inception more than 30 years ago. In 2018, federal Right To Try legislation was passed in the United States, creating a second pathway—one that bypasses the US Food and Drug Administration—to obtain unapproved drugs outside of clinical trials. The use of the two programs by community medical oncologists and hematologist-oncologists has not been studied. METHODS: Between October 2019 and February 2020, community oncologists-hematologists from across the United States completed web-based surveys about EA and Right To Try pathways for accessing unapproved drugs for their patients. Physicians were asked about their utilization of, and perceptions of, the two programs. RESULTS: Of the 238 physicians who completed the survey, 46% indicated that they had attempted to gain access to an investigational drug for a patient using the EA program, whereas 14% reported attempting to use Right To Try pathway to obtain an unapproved drug for a patient. Eighty-nine percent of those who tried to use the EA program reported success in obtaining the investigational drug versus 73% of those who attempted to use the Right To Try pathway. CONCLUSION: Our survey found that most community oncologists-hematologists were aware of both the EA and Right To Try pathways, but there is room for improvement in understanding and utilization of the programs.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

The connection between the «color revolutions» and the strategic doctrines of the United States (late 20th century — 2014)

2021 ◽  
Author(s):  
Anna Igorevna Filimonova
Keyword(s):  
United States ◽  
20Th Century ◽  
American Foreign Policy ◽  
Use Of Force ◽  
The United States ◽  
Time Interval ◽  
Late 20Th Century ◽  
The Us ◽  
Color Revolutions ◽  
The Right

After the collapse of the USSR, fundamentally new phenomena appeared on the world arena, which became a watershed separating the bipolar order from the monopolar order associated with the establishment of the US global hegemony. Such phenomena were the events that are most often called «revolutions» in connection with the scale of the changes being made — «velvet revolutions» in the former Eastern Bloc, as well as revolutions of a different type, which ended in a change in the current regimes with such serious consequences that we are also talking about revolutionary transformations. These are technologies of «color revolutions» that allow organizing artificial and seemingly spontaneous mass protests leading to the removal of the legitimate government operating in the country and, in fact, to the seizure of power by a pro-American forces that ensure the Westernization of the country and the implementation of "neoliberal modernization", which essentially means the opening of national markets and the provision of natural resources for the undivided use of the Western factor (TNC and TNB). «Color revolutions» are inseparable from the strategic documents of the United States, in which, from the end of the 20th century, even before the collapse of the USSR, two main tendencies were clearly traced: the expansion of the right to unilateral use of force up to a preemptive strike, which is inextricably linked with the ideological justification of «missionary» American foreign policy, and the right to «assess» the internal state of affairs in countries and change it to a «democratic format», that is, «democratization». «Color revolutions», although they are not directly mentioned in strategic documents, but, being a «technical package of actions», straightforwardly follow from the right, assigned to itself by Washington, to unilateral use of force, which is gradually expanding from exclusively military actions to a comprehensive impact on an opponent country, i.e. essentially a hybrid war. Thus, the «color revolutions» clearly fit into the strategic concept of Washington on the use of force across the entire spectrum (conventional and unconventional war) under the pretext of «democratization». The article examines the period of registration and expansion of the US right to use force (which, according to the current international law, is a crime without a statute of limitations) in the time interval from the end of the twentieth century until 2014, filling semantic content about the need for «democratic transformations» of other states, with which the United States approached the key point of the events of the «Arab spring» and «color revolutions» in the post-Soviet space, the last and most ambitious of which was the «Euromaidan» in Ukraine in 2014. The article presents the material for the preparation of lectures and seminars in the framework of the training fields «International Relations» and «Political Science».

Where to limit the freedom of speech? Analysis in the context of the First Amendment to the US Constitution and the fighting words doctrine

2021 ◽  
Vol 37 (2) ◽  
pp. 239-256
Author(s):  
Karolina Palka
Keyword(s):  
United States ◽  
First Amendment ◽  
Free Speech ◽  
Freedom Of Speech ◽  
The United States ◽  
National Socialist ◽  
The Us ◽  
Us Constitution ◽  
Socialist Party Of America ◽  
The Right

This article is about the limits of the right to free speech. The first section provides a brief introduction to this topic, primarily in the context of the First Amendment to the U.S. Constitution. The second section describes the case of Chaplinsky v. New Hampshire, which was fundamental to the topic of this paper because the United States Supreme Court created the so-called "fighting words" doctrine based on it. In the next two sections, two court cases are presented that perfectly demonstrate the limits of the right to free speech in the United States: Snyder v. Phelps and Village of Skokie v. National Socialist Party of America. The fifth part shows the right to freedom of speech in the context of Polish civil, criminal, and constitutional law, as well as acts of international law binding on Poland. The last part is a short summary.

scholarly journals Whole-Brain Radiotherapy for Brain Metastases: Evolution or Revolution?

2018 ◽  
Vol 36 (5) ◽  
pp. 483-491 ◽  
Author(s):  
Paul D. Brown ◽  
Manmeet S. Ahluwalia ◽  
Osaama H. Khan ◽  
Anthony L. Asher ◽  
Jeffrey S. Wefel ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Brain Metastases ◽  
Whole Brain Radiotherapy ◽  
The United States ◽  
Alternative Therapies ◽  
Diagnosis And Treatment ◽  
Whole Brain ◽  
Patients With Cancer ◽  
Brain Radiotherapy

An estimated 20% of patients with cancer will develop brain metastases. Approximately 200,000 individuals in the United States alone receive whole-brain radiotherapy (WBRT) each year to treat brain metastases. Historically, the prognosis of patients with brain metastases has been poor; however, with new therapies, this is changing. Because patients are living longer following the diagnosis and treatment of brain metastases, there has been rising concern about treatment-related toxicities associated with WBRT, including neurocognitive toxicity. In addition, recent clinical trials have raised questions about the use of WBRT. To better understand this rapidly changing landscape, this review outlines the treatment roles and toxicities of WBRT and alternative therapies for the management of brain metastases.

scholarly journals Disparity in Clinical Trial Opportunities for Patients with B-Cell Malignancies in the United States

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4861-4861
Author(s):  
Sikander Ailawadhi ◽  
Sri Lekha Bodepudi ◽  
Zan Tahir Shareef ◽  
Fabiola Coromoto Cardozo ◽  
Salman Ahmed ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Geographical Distribution ◽  
Research Funding ◽  
Phase 1 ◽  
The United States ◽  
Phase 2 ◽  
B Cell Malignancies ◽  
The Us

Abstract Background: Clinical trials are fundamental to advance therapeutics systematically and improve patient outcomes. Despite this, enrollment on clinical trials remains dismal in the United States (US) and is a constant focus of healthcare policy. We studied distribution of clinical trials for B-cell malignancies over time across the US and unique clinical trial opportunities i.e. individual clinical trials for the given diagnosis at a site that patients may have access to participate. Methods: We abstracted data from clinicaltrials.gov for all trials that had non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) as an inclusion indication between 1999-2018. Clinical trial characteristics and distribution over US geographical divisions (West, Midwest, Northeast, and South) were studied, and differences were assessed by Chi-square test. Results: A total of 1930 trials were identified (NHL: 982, MM: 948), of which 483 were recruiting at the time of data abstraction (NHL: 250, MM: 233). Over the past 2 decades, 182691 patients were enrolled on the various trials (NHL: 81592, MM: 101099). Trials by phase of study included phase 1: 629, phase 1/2: 316, phase 2: 813, phase 2/3: 11 and phase 3: 161. Number of trials by phase separated by NHL and MM are shown in Figure 1. Of these, 197 trials were randomized (NHL: 67, MM: 130). Geographical distribution of trials by diagnosis type is shown in Figure 2. A total of 31806 unique trial opportunities were noted for MM and NHL, of which 9,513 were international and 22,293 were in the US, with a geographical distribution of 5080 in West, 8198 in Midwest, 3944 in Northeast, and 5071 in South. 4,883 of the unique trial opportunities were available at NCI/NCCN accredited sites and 17,410 were at non-NCI/NCCN sites in the US. Treatment characteristics of the trials included monoclonal antibodies in 1218, other targeted agents in 2641, stem cell transplant in 526, and other agents in 517 trials with several trials utilizing more than one of these therapeutic options. There was no statistically significant difference in the distribution of clinical trials by phase of study across various US geographical regions for MM (p=0.71), NHL (p=0.98) or combined MM+NHL (p=0.16). On the other hand, unique trial opportunities were significantly different by study phase and geographical distribution for MM, NHL or MM+NHL (all p<0.001) (Figure 3). Conclusions: Widespread access to clinical trials within a cancer diagnosis is imperative for generalizability of trial results. In a comprehensive, national analysis we noted that while it may appear that clinical trials are available across the US, sites where they are open are distributed unevenly, giving rise to a disparity in access to evidence-based therapeutic advancements for patients. Disclosures Ailawadhi: Janssen: Consultancy; Amgen: Consultancy; Pharmacyclics: Research Funding; Takeda: Consultancy; Celgene: Consultancy. Sher:Affimed: Research Funding.

The United States and Elections in Africa (2015–2018)

2019 ◽  
pp. 58-98 ◽  
Author(s):  
Andrey Urnov
Keyword(s):  
United States ◽  
Democratic Republic Of Congo ◽  
The United States ◽  
African Countries ◽  
The Us ◽  
Global Leader ◽  
The Usa ◽  
The Right ◽  
Selection Of

As a self-proclaimed “Global Leader” the United States have made “the assertion, advancement, support and defense of democracy” throughout the world one of the pillars of their foreign policy. This aim invariably figures in all Washington’s program documents pertaining to Africa. A major component of these efforts is an assistance to regular, free and fair elections. The selection of arguments cited to justify such activities has been done skilfully. In each specific case it is emphasized that the United States do not side with any competing party, stand “above the battle”, work for the perfection of electoral process, defend the rights of opposition and rank and file votes, render material and technical help to national electoral committees. Sounds irreproachable. However, the real situation is different. The study of the US practical activities in this field allows to conclude that Washington has one-sidedly awarded itself a role of a judge and supervisor of developments related to elections in the sovereign countries of Africa, tries to control the ways they are prepared and conducted. These activities signify an interference into the internal affairs of African states. The scale and forms of such interference differ and is subjected to tasks the USA try to resolve in this or that country on the national, regional or global levels. However, everywhere it serves as an instrument of penetration and strengthening of the US influence, enhancing the US political presence in African countries. The right of the US to perform this role is presented as indisputable. Sceptics are branded as opponents of democracy. The author explores the US positions and activities connected with elections in Africa during the last years of B.Obama and first two years of D.Trump presidencies. He shows how their policy have been implemented on the continental level and in regard to several countries – South Sudan, Libya, Democratic Republic of Congo, Burundi, Rwanda, Nigeria, Somali, Kenya, Uganda.

scholarly journals Wisconsin April 2020 Election Not Associated with Increase in COVID-19 Infection Rates

2020 ◽  
Author(s):  
Andrew C. Berry ◽  
Madhuri S. Mulekar ◽  
Bruce B. Berry
Keyword(s):  
United States ◽  
Incubation Period ◽  
Case Reports ◽  
The United States ◽  
Infection Rates ◽  
Web Based ◽  
Primary Election ◽  
Milwaukee County ◽  
The Us ◽  
Voting Age

AbstractBackgroundWisconsin (WI) held a primary election in the midst of the COVID-19 pandemic. Live voting at polls was allowed despite concern over increasing the spread of COVID-19. In addition to 1.1 million absentee ballots cast, 453,222 persons voted live. The purpose of our study was to determine if an increase in COVID-19 activity was associated with the election.MethodsUsing the voting age population for the United States (US), WI, and its 3 largest counties, and daily new COVID-19 case reports from various COVID-19 web-based dashboards, daily new case rates were calculated. With election day April 7, the incubation period included April 12-21. The new case activity in the rest of the US was compared with the Wisconsin activity during the incubation period.ResultsWI daily new case rates were lower than those of the rest of the US for the 10-day period before the election and remained lower during the post exposure incubation period. The ratio of Wisconsin new case rates to US new case rates was 0.34 WI: 1 US for the 10 days leading up to the election and declined to 0.28 WI: 1 US for the 10-day post-incubation period after the election. Similar analysis for Milwaukee county showed a pre-election ratio of 1.02 Milwaukee: 1 US and after the election the ratio was 0.63 Milwaukee: 1 US. Dane county had a pre-election ratio of 0.21 Dane: 1 US case, and it fell to 0.13 Dane: 1 US after the election. Waukesha county had a pre-election ratio of 0.27 Waukesha: 1 US case and that fell to 0.19 Waukesha: 1 US after the election.ConclusionsThere was no increase in COVID-19 new case daily rates observed for Wisconsin or its 3 largest counties following the election on April 7, 2020, as compared to the US, during the post-incubation interval period.

Alternative Ways to Resolve Disputes Related to Consumer Protection of Financial Services in Hong Kong, Singapore and the United States: Innovations 2017 – 2019

2020 ◽  
Vol 11 (2) ◽  
pp. 394
Author(s):  
Natalia V. IVANOVSKAYA ◽  
Sergey S. ISAI
Keyword(s):  
United States ◽  
Hong Kong ◽  
Consumer Protection ◽  
Financial Services ◽  
Practical Experience ◽  
The United States ◽  
Alternative Methods ◽  
The Us ◽  
The Right ◽  
Goals And Objectives

The authors explore regulatory innovations in financial services consumer protection in Hong Kong, Singapore, and the United States. It was revealed that: (1) the priority of such an alternative way of regulating financial demand with the participation of consumers as mediation is ensured by the activities of the FDRC Center in Hong Kong, and in Singapore – by the new law on mediation in 2017; (2) the creation of a unified mediation model, which is mandatory for all member states – the Singapore Convention on Mediation 2019 – will allow mediation to become the most widely used alternative way to resolve cross-border, including financial, disputes; (3) a positive result of the application of arbitration in the field of settlement of financial disputes with the participation of large banks can be achieved by creating certain conditions, including by attracting highly professional arbitrators with extensive practical experience, as, for example, was done by the Hong Kong International Arbitration Center (HKIAC); (4) on the example of the US experience, one can also identify another way to improve the mechanisms for resolving financial disputes, the goals and objectives of which are shifted from the vector of propaganda and updating alternative methods of resolving financial disputes to improving the mechanism for providing financial services; (5) the inclusion of a clause on the mandatory resolution of possible disputes in arbitration, as a mandatory part of the contract itself with consumers, indicates the deprivation of the right to choose the method of resolving the dispute by the consumer, and also deprives them of the right to file collective claims.

Clinical Cancer Advances 2010: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology

2010 ◽  
Vol 28 (36) ◽  
pp. 5327-5347 ◽  
Author(s):  
Mark G. Kris ◽  
Steven I. Benowitz ◽  
Sylvia Adams ◽  
Lisa Diller ◽  
Patricia Ganz ◽  
...  
Keyword(s):  
United States ◽  
Cancer Research ◽  
Clinical Trials ◽  
Clinical Oncology ◽  
The United States ◽  
Cooperative Group ◽  
Institute Of Medicine ◽  
Group Program ◽  
American Society ◽  
The Right

A MESSAGE FROM ASCO'S PRESIDENT Like many health professionals who care for people with cancer, I entered the field because of specific patients who touched my heart. They still do. In an effort to weave together my personal view of what the American Society of Clinical Oncology (ASCO) stands for and the purpose the organization serves, my presidential theme this year is “Patients. Pathways. Progress.” Patients come first. Caring for patients is the most important, rewarding aspect of being an oncology professional. At its best, the relationship between doctor and patient is compassionate and honest—and a relationship of mutual respect. Many professional organizations have an interest in cancer, but no other society is so focused on the entire spectrum of cancer care, education, and research. Nor is any other society as particularly interested in bringing new treatments to our patients through clinical trials as ASCO is. Clinical trials are the crux for improving treatments for people with cancer and are critical for continued progress against the disease. “Pathways” has several meanings. Some pathways are molecular—like the cancer cell's machinery of destruction, which we have only begun to understand in recent years. But there are other equally important pathways, including the pathways new therapies follow as they move from bench to bedside and the pathways patients follow during the course of their diseases. Improved understanding of these pathways will lead to new approaches in cancer care, allowing doctors to provide targeted therapies that deliver improved, personalized treatment. The best pathway for patients to gain access to new therapies is through clinical trials. Trials conducted by the National Cancer Institute's Cooperative Group Program, a nationwide network of cancer centers and physicians, represent the United States' most important pathway for accelerating progress against cancer. This year, the Institute of Medicine released a report on major challenges facing the Cooperative Group Program. Chief among them is the fact that funding for the program has been nearly flat since 2002. ASCO has called for a doubling of funding for cooperative group research within five years and supports the full implementation of the Institute of Medicine recommendations to revitalize the program. ASCO harnesses the expertise and resources of its 28,000 members to bring all of these pathways together for the greater good of patients. Progress against cancer is being made every day—measurable both in our improved understanding of the disease and in our ability to treat it. A report issued in December 2009 by the National Cancer Institute, the Centers for Disease Control and Prevention, the American Cancer Society, and the North American Association of Central Cancer Registries found that rates of new diagnoses and rates of death resulting from all cancers combined have declined significantly in recent years for men and women overall and for most racial and ethnic populations in the United States. The pace of progress can be and needs to be hastened. Much remains to be done. Sustained national investment in cancer research is needed to bring better, more effective, less toxic treatments to people living with cancer. Pathways to progress continue in the clinic as doctors strive to find the right treatments for the right patients, to understand what represents the right treatments, and to partner with patients and caregivers for access to those treatments. This report demonstrates that significant progress is being made on the front lines of clinical cancer research. But although our nation's investment in this research is paying off, we must never forget the magnitude of what lies ahead. Cancer remains the number two killer of Americans. Future progress depends on continued commitment, from both ASCO and the larger medical community. George W. Sledge Jr, MD President American Society of Clinical Oncology

scholarly journals The Politics of ‘Dolphin-Safe’ Tuna in the United States: Policy Change and Reversal, Lock-in and Adjustment to International Constraints (1984–2017)

2017 ◽  
Vol 17 (4) ◽  
pp. 635-663 ◽  
Author(s):  
RODRIGO FAGUNDES CEZAR
Keyword(s):  
United States ◽  
Policy Change ◽  
World Trade ◽  
The United States ◽  
Process Tracing ◽  
The Us ◽  
The World ◽  
The Right ◽  
Lock In ◽  
Tracing Method

AbstractRecently, the World Trade Organization (WTO) granted Mexico the right to retaliate against the US as a compensation for losses related to the US ‘dolphin-safe’ label (May 2017). Despite the diversity of works on the issue, few analyze the changes in the US approach to dolphin protection as a result of international and domestic pressures related to the tuna–dolphin controversy. This paper seeks to understand such changes and their consequences using the process tracing method. It shows that (1) the US approach to dolphin protection passed through a process of policy change motivated by trade and diplomatic concerns mediating dolphin protection, and that (2) it was partially reversed in court as an outcome of the concessions offered to get the policy change approved. Finally, the paper argues that (3) this process led to the lock-in of the US ‘dolphin-safe’ label and to its expansion in response to recent WTO decisions.

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