scholarly journals American Industry and the U.S. Cardiovascular Clinical Research Enterprise

2011 ◽  
Vol 58 (7) ◽  
pp. 677-680 ◽  
Author(s):  
Robert M. Califf ◽  
Robert A. Harrington
Keyword(s):  
Clinical Research ◽  
American Industry ◽  
The U.S

scholarly journals Protocol Development: A Contract Between Sponsor and Investigator

2019 ◽  
Vol 9 (4-s) ◽  
pp. 844-845
Author(s):  
Rada Santosh Kumar ◽  
B. Joshna
Keyword(s):  
Clinical Research ◽  
Outcome Measures ◽  
Drug Administration ◽  
Design Methodology ◽  
European Medicines Agency ◽  
Data Handling ◽  
Research Protocol ◽  
Record Keeping ◽  
Protocol Development ◽  
The U.S

The main aim of this review which is published by the European Medicines Agency EMEA and the U.S. Food and Drug Administration (FDA)[1-7] is to describe about the importance of protocol in clinical trials.When developing a successful study designand writing a protocol, the researcher must address various successful components including the type of data being collected, data handling, record keeping, outcome measures. A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations and organization of clinical research project.

scholarly journals The Problem-Oriented Record in Psychiatry

1973 ◽  
Vol 7 (3) ◽  
pp. 138-141 ◽  
Author(s):  
Alex J. Gilandas
Keyword(s):  
Clinical Research ◽  
Record Keeping ◽  
System A ◽  
Progress Notes ◽  
The U.S ◽  
Oriented Approach

The problem-oriented approach to record keeping developed by Lawrence Weed, M.D. is having a significant impact upon psychiatry in the U.S. Under the system, a patient&s problems are listed and all subsequent data, plans and progress notes are cross-indexed to the appropriate problems. This encourages the use of sound logic in therapy. Communication with others about the patient is also improved. Although the system does not require a computer it anticipates and facilitates the computerization of psychiatric records. Precise documentation also allows more accurate clinical research. Some problems posed by the system are also discussed.

scholarly journals ISSUES OF INDIVIDUAL CAPITALISM IN THE NARRATIVE FILM OF THANK YOU FOR SMOKING AND THE COMPANY MEN

Lire Journal ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. 16-25
Author(s):  
Sukarni Suryaningsih
Keyword(s):  
American Industry ◽  
Hollywood Movies ◽  
Narrative Film ◽  
The U.S ◽  
Economic Character

The idea of capitalism always refers to the triumph of the U.S. giant industry. In economic field, American and British capitalism is called as individual capitalism – the contrary of communal capitalism a la Japan and Germany. This paper is intended to examine the identity of economic character of individual capitalism in two Hollywood movies Thank You for Smoking (2006) and The Company Men (2010). Exploring the theory of individual and communal capitalism stated by Lester Thurow, it can be found that through mechanistic relationship, hard individual competition and unending punishment, those all erase emotional bound between individual and corporation. In short it becomes one of the reasons why American industry perishes its superiority slowly.

scholarly journals Lack of clinical trial data transparency and current solutions

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Tabassom Baghai
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
World Health Organization ◽  
Clinical Trial Data ◽  
Trial Data ◽  
World Health ◽  
The World ◽  
Data Transparency ◽  
Health Organization ◽  
The U.S

An ongoing challenge in clinical research is the inaccessibility of clinical trial data, which prevents physicians from making an informed decision with regards to patient care. The U.S. Food and Drug Administration (FDA) as well as the World Health Organization (WHO) recently called for all trial data to be registered and made publically available. However, this issue is still ongoing and there are several measures currently being enforced to rectify these concerns. Potential solutions, such as regulations, campaigns, and possible conse- quences, for increasing transparency in clinical trial data will be discussed. RÉSUMÉ L’inaccessibilité des données provenant d’essais cliniques constitue un défi constant en recherche clinique, puisqu’elle empêche les médecins de prendre des décisions éclairées quant aux soins de leurs patients. Récemment, le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) ainsi que l’Organisation mondiale de la Santé (OMS) ont demandé que toutes les données d’essais cliniques soient enregistrées et mises à la disposition du public. Toutefois, ce problème persiste et plusieurs mesures ont été mises en place pour répondre à ces préoccupations. Des solutions possibles dont des réglementations, des campagnes et des sanctions possibles pour améliorer la transparence en ce qui concerne les données d’essais cliniques seront discutées. 

Improving the Recruitment of Minority Populations in Clinical Trials

2017 ◽  
pp. 1354-1367
Author(s):  
Saliha Akhtar ◽  
Michelle Lee D'Abundo
Keyword(s):  
Clinical Research ◽  
Leadership Strategies ◽  
Minority Populations ◽  
Healthcare Industry ◽  
Minority Recruitment ◽  
Contributing Factors ◽  
Community Based ◽  
Organizational Perspective ◽  
Clinical Research Trials ◽  
The U.S

Clinical research trials are an important part of establishing evidence-based practice in the U.S. healthcare industry. The purpose of this chapter is to review how the recruitment of minority populations can be improved by creating a strategic shift toward community-based recruitment. The problem of insufficient minority recruitment is defined and contributing factors are reviewed. The relevancy of Lewin's change theory is explained from a staff and organizational perspective. Specific community-based change and leadership strategies that can be applied to clinical research organizations to create a strategic shift to increase minority recruitment are evaluated. Through making minority recruitment a strategic priority, staff and organizations can work with communities to resolve a salient issue in the U.S. healthcare industry.

scholarly journals A Pilot Survey on the Licensing of DNA Inventions

2003 ◽  
Vol 31 (3) ◽  
pp. 442-449 ◽  
Author(s):  
Michelle R. Henry ◽  
Mildred K. Cho ◽  
Meredith A. Weaver ◽  
Jon F. Merz
Keyword(s):  
Intellectual Property ◽  
Research And Development ◽  
Clinical Research ◽  
Financial Risks ◽  
Practical Applications ◽  
Pilot Survey ◽  
Medical Tests ◽  
Negative Effect ◽  
Genetic Sequences ◽  
The U.S

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access.

The 2008 Declaration of Helsinki — First among Equals in Research Ethics?

2010 ◽  
Vol 38 (1) ◽  
pp. 143-148 ◽  
Author(s):  
Annette Rid ◽  
Harald Schmidt
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Standard Of Care ◽  
The United States ◽  
Basic Principles ◽  
Declaration Of Helsinki ◽  
The World ◽  
Ethical Guidance ◽  
Post Trial ◽  
The U.S

The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration (FDA) recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

ASCO Research Community Forum: Impact on clinical research.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 299-299
Author(s):  
David Michael Waterhouse ◽  
Nicholas J. Robert ◽  
Edward S. Kim ◽  
Dax Kurbegov ◽  
Howard A. Burris III ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Clinical Research ◽  
Research Community ◽  
Site Quality ◽  
Steady Increase ◽  
Research Education ◽  
Oncology Research ◽  
Community Forum ◽  
The U.S

299 Background: In 2011, ASCO launched a forum for the oncology research community to facilitate and promote the implementation of quality clinical research. The ASCO Research Community Forum (RCF) was created to provide a solution-oriented venue for research sites to address common challenges with conducting clinical trials. It offers in-person and virtual forums and resources to learn and share best practices with peers on a variety of topics, including site quality assessment and improvement, research site operations, and clinical trial access and accrual. Methods: An assessment was performed to measure the ASCO RCF output and to gather information on its potential impact on the cancer community. Results: The ASCO RCF has provided an in-person venue for physicians and research administrators with a steady increase in attendance, from 52 attendees in 2012 to 159 in 2018. Multi-stakeholder meetings and manuscripts have promoted best practices and solutions to address challenges with implementing quality clinical trials. Tools and resources to facilitate best practices and quality improvement at trial sites have been accessed by a range of types of research sites from across the U.S. and internationally. Its web-based library of resources was accessed over 27,000 times in 2018, alone. An online forum was launched in 2019 to provide a new opportunity to connect and impact the research community. Conclusions: The ASCO RCF is a productive and esteemed resource for the cancer research community. In-person and virtual forums, along with practical tools, promote access and accrual to clinical trials by facilitating networking, developing solutions, and providing education and resources. The ASCO RCF impact has extended from community-based oncology practices to larger research networks and academic centers across the U.S. and internationally. Its efforts to promote and facilitate access to quality clinical trials align with the vision and mission of ASCO to conquer cancer through research, education, and promotion of the highest quality patient care.

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