Befangenheit von Mitgliedern der Ethik-Kommission im Rahmen klinischer Arzneimittelstudien

2019 ◽  
Author(s):  
Dennis Weishaupt
Keyword(s):  
Conflicts Of Interest ◽  
Pharmaceutical Companies ◽  
Drug Trials ◽  
Legal Standards ◽  
Federal Authority ◽  
Legal Situation ◽  
Clinical Drug Trials ◽  
Ethics Commission ◽  
Ethics Commissions ◽  
Clinical Drug

Due to unknown health risks, clinical drug trials on humans are subject to particularly rigid medical end ethical-legal standards. Their observance is monitored by the ethics commission in consultation with a higher federal authority. In light of the economic interest of pharmaceutical companies in the approval of the study, and of the limited number of experts, especially in specialist medical areas, conflicts of interest may occur in this context. Against this background, the author deals with the requirements of the exclusion of commissioners, as well as with the consequences of unauthorised involvement. Due to the regulation (EU) No. 536/2014 and the following 4th amendment, the legal situation with respect to conflicts of interest, as well as the licensing procedure, was altered. The author discusses, in particular, the new allocation of responsibilities between the ethics commissions and the higher federal authority.

scholarly journals Financial Conflicts of Interest Among Oncologist Authors of Reports of Clinical Drug Trials

JAMA Oncology ◽  
2018 ◽  
Vol 4 (10) ◽  
pp. 1426 ◽  
Author(s):  
Cole Wayant ◽  
Erick Turner ◽  
Chase Meyer ◽  
Philip Sinnett ◽  
Matt Vassar
Keyword(s):  
Conflicts Of Interest ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
Financial Conflicts Of Interest ◽  
Clinical Drug

Pharmacist Involvement in Norwegian Clinical Drug Trials: A Questionnaire Study

1986 ◽  
Vol 20 (5) ◽  
pp. 391-395 ◽  
Author(s):  
Inger Lise Eriksen ◽  
Erik Andrew
Keyword(s):  
Pharmaceutical Industry ◽  
Response Rate ◽  
Community Pharmacists ◽  
Questionnaire Study ◽  
Community Pharmacies ◽  
Pharmaceutical Companies ◽  
Drug Trials ◽  
Hospital Pharmacists ◽  
Clinical Drug Trials ◽  
Clinical Drug

In order to survey the involvement of pharmacists in clinical drug trials (CDTs) in Norway, a questionnaire was submitted to all community pharmacies (288), pharmacy departments in hospitals (98), and pharmaceutical companies (52). The response rate was 81, 73, and 64 percent, respectively. Community pharmacies had minimal involvement, while 34 percent of the pharmacy departments had taken part in one or more CDTs annually 1980–1982. During the same three-year period, 393 trials had been started by the responding companies. Within the pharmaceutical industry 41 percent of the CDT staff were pharmacists. Pharmacists in 48 percent of community pharmacies and 96 percent of pharmacy departments in hospitals considered CDTs a pharmaceutical task. However, none of the community pharmacists and less than half of the hospital pharmacists said they had knowledge of CDT methodology. We recommend that pharmacists should be more extensively engaged in CDTs. Their participation should not be limited to traditional pharmaceutical work, but should include CDT planning and monitoring. This in turn requires education in CDT methodology, which should be included in the compulsary pharmaceutical curriculum.

Methodology of Clinical Drug Trials.

1995 ◽  
Vol 90 (429) ◽  
pp. 390
Author(s):  
Ralph B. D'Agostino ◽  
Alain Spriet ◽  
Therese Dupin-Spriet ◽  
Pierre Simon ◽  
Robert Coluzzi ◽  
...  
Keyword(s):  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

scholarly journals Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection?

2012 ◽  
Vol 46 (3) ◽  
pp. 113-116
Author(s):  
Roosy Aulakh ◽  
Chander Shekhar Gautam ◽  
Prabhjot Singh Cheema
Keyword(s):  
Animal Experimentation ◽  
New Drugs ◽  
Drug Trials ◽  
Human Beings ◽  
Animal Protection ◽  
Research Organizations ◽  
Legal Sanctions ◽  
Clinical Drug Trials ◽  
Health Care Law ◽  
Clinical Drug

ABSTRACT Health care law is totally localized in its nature, but research for the development of new drugs has crossed man-made geographical limits. Weaker legal sanctions, poverty, illiteracy and inaccessibility to legal system have all contributed to make India a favored hub for contact research organizations. Many recent clinical drug trials in India have sparked controversy. However, in India today, we are more bothered about animal protection, but show little concern for volunteers in human trials. It is gradually becoming difficult to conduct research on animals; however, research on human beings is far easier. Sanctions against violation of rights of human volunteers in clinical trials are often only a perceived phenomenon. They are not protected as they should be. Regulatory framework needs thorough introspection, debate, reconsideration and strict implementation. These guidelines should not only be recommendatory but mandatory in nature and those who indulge in violations, shall be punished as per the law of the land effectively. How to cite this article Gautam CS, Aulakh R, Cheema PS. Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection? J Postgrad Med Edu Res 2012;46(3):113-116.

Clinical Drug Trials in Alzheimer Disease What are Some of the Issues?

1990 ◽  
Vol 4 (4) ◽  
pp. 193-202 ◽  
Author(s):  
Lissy F. Jarvik ◽  
Leonard Berg ◽  
Raymond Bartus ◽  
Leonard Heston ◽  
Nancy Leith ◽  
...  
Keyword(s):  
Alzheimer Disease ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

Methodologic Issues regarding Outcome Measures for Clinical Drug Trials of Psychiatric Complications in Dementia

1995 ◽  
Vol 8 (1_suppl) ◽  
pp. 8-17
Author(s):  
Linda Teri ◽  
Rebecca G. Logsdon
Keyword(s):  
Outcome Measures ◽  
Outcome Research ◽  
Drug Trials ◽  
Psychometric Characteristics ◽  
Content Assessment ◽  
Dementia Patients ◽  
Prior Use ◽  
Clinical Drug Trials ◽  
Psychiatric Complications ◽  
Clinical Drug

Selecting outcome measures that are both psychometrically sound and sensitive to change is a very important aspect of clinical outcome research. A variety of measures have been introduced in recent years to assess behavioral complications in dementia, but few have been adequately tested in clinical trials. This article provides a discussion of factors to consider in selecting measures, including psychometrics, item content, assessment source, and sensitivity to change. A review of behavioral and psychiatric measures for dementia patients is provided, including measures of general behavioral disturbance, and measures specifically developed for agitation and depression. Each measure's psychometric characteristics, prior use with demented patients, and strengths and weaknesses with regard to treatment outcome research is summarized. The importance of linking measures to the investigators’ hypotheses is discussed, along with recommendations for evaluating and selecting outcome measures depending on the needs of the specific investigation. ( J Geriatr Psychiatry Neurol 1995; 8(suppl 1):S8–S17).

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