scholarly journals Clinical research in developing countries: recent moral arguments

2002 ◽  
Vol 18 (5) ◽  
pp. 1455-1461 ◽  
Author(s):  
Douglas P. Lackey
Keyword(s):  
Developing Countries ◽  
Clinical Trials ◽  
Clinical Research ◽  
Ethical Problems ◽  
Declaration Of Helsinki ◽  
The Us ◽  
Advisory Commission ◽  
Moral Arguments

During the 1990s, bioethicists raised questions about certain clinical trials conducted in developing countries. These inquiries led to revisions in the Declaration of Helsinki and recommendations from the US National Bioethics Advisory Commission. This article raises doubts about the original questions and subsequent recommendations. It is possible that impractical solutions have been proposed for nonexistent ethical problems.

scholarly journals A Historic View of the US Business Ethical Laws and Implications for Developing Countries like China

2016 ◽  
Vol 8 (3) ◽  
pp. 49 ◽  
Author(s):  
Zheng-guo Zhu ◽  
Wen-zhong Zhu
Keyword(s):  
Developing Countries ◽  
Ethical Dilemmas ◽  
Business Environment ◽  
Ethical Problems ◽  
Us History ◽  
Ethical Behaviors ◽  
The Us ◽  
The Government ◽  
The Times ◽  
Institutional Construction

<p>In the nearly 150 years of the US history, following big historical events or business ethical dilemmas, the business ethical laws have evolved gradually, which can be divided into 11 stages in 4 levels. In each stage, the emphases or governance purposes of the business ethical laws differ greatly, but tend to bear the sign of the times. Through the systematic review and analysis, the paper concludes that in a specific era of the history, when facing a specific ethical dilemma, the government or regulatory authority will develop and perfect the related regulations or norms of business ethical behaviors in line with the feature of the period so as to effectively prevent or solve the ethical problems in the business environment. The practice of the US institutional construction may be of some enlightenment for developing countries like China.</p>

scholarly journals Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries

2016 ◽  
Vol 131 (3) ◽  
pp. 396-403 ◽  
Author(s):  
Jonathan Kagan ◽  
Dao Duc Giang ◽  
Michael F. Iademarco ◽  
Van TT Phung ◽  
Chuen-Yen Lau ◽  
...  
Keyword(s):  
Developing Countries ◽  
Clinical Trials ◽  
Clinical Research ◽  
Research Capacity

The strength of pharmaceutical IPRs vis-à-vis foreign direct investment in clinical research: Preliminary findings

1969 ◽  
Vol 17 (4) ◽  
Author(s):  
Meir Perez Pugatch ◽  
Rachel Chu
Keyword(s):  
Clinical Trial ◽  
Developing Countries ◽  
Clinical Trials ◽  
Foreign Direct Investment ◽  
Technology Transfer ◽  
Intellectual Property ◽  
Clinical Research ◽  
Direct Investment ◽  
Ip Protection ◽  
Clinical Trial Activity

This article examines the effect of the intellectual property (IP) environment in developing countries on the level of foreign direct investment (FDI) and technology transfer occurring in the biopharmaceutical field in these countries. In particular, it considers the correlation between the strength of IP protection in several developing countries (using the Pharmaceutical IP Index) and the number of clinical trials taking place in these countries (as a proxy of biomedical FDI). The article finds that overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.

scholarly journals Magyar klinikai vizsgálatok sajátosságai egy nemzetközi adatbázis elemzése alapján

2017 ◽  
Vol 158 (9) ◽  
pp. 345-351
Author(s):  
Tamás Tóth ◽  
Péter Pollner ◽  
Gergely Palla ◽  
Elek Dinya
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Data Cleaning ◽  
Free Text ◽  
Research Organizations ◽  
The Us ◽  
Us Government ◽  
International View ◽  
Significant Data

Abstract: Intorduction: The ClinicalTrials.gov website, which is operated by the US government, collects data about clinical trials. Aim: We have processed data related to Hungary by downloading from the website as XML files. Method: Most of the data describe trials performed after 2000, so we got an overview about the clinical research of the last 10 to 15 years. As the majority of the data fields are collected as free text, significant data cleaning was needed. Results: The database contained 2863 trials related to Hungary from 189 settlements. Only 20 per cent of the actual research organizations could have been identified as many times only an “id” number or a general name was given, thus this information was anonymised in many cases. Conclusion: Besides the analysis of the information obtained from this database, our study points out the relevant issues that may influence the international view of the Hungarian clinical research. Orv. Hetil., 2017, 158(9), 345–351.

scholarly journals Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research

2017 ◽  
Vol 49 (6) ◽  
pp. 1700051 ◽  
Author(s):  
Adam T. Hill ◽  
Charles S. Haworth ◽  
Stefano Aliberti ◽  
Alan Barker ◽  
Francesco Blasi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Working Group ◽  
Exercise Tolerance ◽  
Research Collaboration ◽  
Round Table ◽  
Consensus Definition ◽  
The Us ◽  
Sputum Volume ◽  
Definition Of

There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research.A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa.The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.

The Hidden World of Subjects

2016 ◽  
Author(s):  
Rebecca Dresser
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Research Environment ◽  
Ethical Problems ◽  
Research Results ◽  
Partnership Model ◽  
Fertile Ground ◽  
Rule Breaking ◽  
Personal Interests ◽  
Ethical Responsibilities

This chapter looks at subjects’ concealed misbehavior in research. When their personal interests conflict with the demands of participation, some subjects put their own interests first. They don’t follow study requirements and try to hide this fact from researchers. In rejecting the restrictions research imposes, subjects diminish the value of research results. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At the same time, rule-breaking subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for concealed rule-breaking. Intensified policing and guidance are two common strategies for reducing subject misbehavior, but collaborative reforms are more consistent with the partnership model of clinical research.

Clinical Research From Proposal to Implementation

2008 ◽  
Vol 56 (8) ◽  
pp. 975-984 ◽  
Author(s):  
Suzanne M. Rivera
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Protection ◽  
Institutional Review ◽  
The Us ◽  
Complicated Process ◽  
Study Participants ◽  
Review Boards

ABSTRACTThe conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.

scholarly journals Barriers, adoption, technology, impact and benefits of risk based monitoring

2016 ◽  
Vol 3 (1) ◽  
pp. 9 ◽  
Author(s):  
Bharat Kumar Shukla ◽  
Mohammed Saleem Khan ◽  
Veerabhadra Nayak
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Quality ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Source Information ◽  
The Us ◽  
Previous Decade

The expense and unpredictability of clinical trials have increased drastically as of late. Up to third of a clinical trials expense can now be credited to the customary on location audit of trial information. While powerful observing is basic to ensuring the prosperity of trial members and keeping up the respectability of definite results, it is presently by and large acknowledged that the procedure for clinical trial checking needs to change. A more brought together, hazard based methodology is currently the favoured technique for monitoring clinical trials, as per a few administrative offices, including the US Food and Drug Administration (FDA). The movement has demonstrated overwhelming to numerous associations, nonetheless, and it is now and again not clear where to start. Over the previous decade, the clinical research industry's standard to meet regulators monitoring commitments has included continuous and normal onsite monitoring visits with 100% source information confirmation (SDV). The conviction that "more is better" proceeds with new proof that onsite monitoring practices don't inexorably ensure persistent wellbeing and data quality.

scholarly journals Standard of Care in Clinical Research Involving Human Subjects: A Perspective from Developing World

2014 ◽  
Vol 5 (2) ◽  
pp. 68-72
Author(s):  
Muhammad Waseem Khan ◽  
Sanam Zeib Khan ◽  
Afrasiab Khan Tareen ◽  
Imrana Niaz Sultan
Keyword(s):  
Developing Countries ◽  
Human Rights ◽  
Clinical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Standard Of Care ◽  
Vulnerable Population ◽  
Diagnostic Process ◽  
Ethical Problems ◽  
Conducting Research

Standard of care is an ordinary, reasonable formal treatment and diagnostic process that a physician should follow for his/her patient with specific disease. Standard of care followed in one country may not suit to other country; the reason may involve economic conditions, certain norms, beliefs, tradition and culture of that society. It may be considered ethical if it does not exploit human rights and poor vulnerable population, once it exploits the human rights it creates ethical dilemmas that need to be sort out to protect vulnerable population and to make the research more ethical. Patients attending medicine department of Bolan Medical Complex (BMC) Quetta, Balochistan, Pakistan were selected randomly interviewed and requested to fill the questionnaire. The ethical issues in clinical research conducted on human population have been perplexing and remains to be the same in clinical research settings. Exploitive use of research participants in resource poor developing countries has intensified the debate on the ethics of international research and led to increasing attention to exploitation of vulnerable study subjects. The issues of conducting research in developing countries will remain and need to be focused and debated where and whenever require. One has to try sincerely to sort out the ethical problems while conducting a research study, he might fail to solve all the issues but the situation may improve by the time if tried sincerely.DOI: http://dx.doi.org/10.3329/bioethics.v5i2.19617 Bangladesh Journal of Bioethics 2014 Vol.5(2):68-72 

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