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62 records – page 1 of 7.

Acceptability and profile of the clinical drug trials underway in Finnish university hospitals in the 1990s: applications reviewed by ethics committees.

https://arctichealth.org/en/permalink/ahliterature192044
Source
Methods Find Exp Clin Pharmacol. 2001 Sep;23(7):415-23
Publication Type
Article
Date
Sep-2001
Author
T. Keinonen
S. Nieminen
V. Saareks
V. Saano
P. Ylitalo
Author Affiliation
Department of Pharmacology and Toxicology, University of Kuopio, Finland. tuija.keinonen@medfiles.fi
Source
Methods Find Exp Clin Pharmacol. 2001 Sep;23(7):415-23
Date
Sep-2001
Language
English
Publication Type
Article
Keywords
Clinical Protocols - standards
Clinical Trials Data Monitoring Committees - statistics & numerical data
Clinical Trials as Topic - standards - statistics & numerical data
Ethics Committees, Research - statistics & numerical data
Finland
Hospitals, University - statistics & numerical data
Humans
Informed Consent - statistics & numerical data
Multicenter Studies as Topic - statistics & numerical data
Patient Selection
Practice Guidelines as Topic
Research Design - standards - statistics & numerical data
Retrospective Studies
Abstract
There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
PubMed ID
11771857 View in PubMed
Less detail

[A diploma in clinical testing increases knowledge and self-esteem. Assessment of practical benefits for both the diploma-holders and employers].

https://arctichealth.org/en/permalink/ahliterature189457
Source
Lakartidningen. 2002 Jun 13;99(24):2751-3
Publication Type
Article
Date
Jun-13-2002

Antiarrhythmic drug approval--a clinical investigator's perspective.

https://arctichealth.org/en/permalink/ahliterature227095
Source
Can J Cardiol. 1991 Jan-Feb;7(1):44; discussion 49-50
Publication Type
Article
Author
R. Nadeau
Source
Can J Cardiol. 1991 Jan-Feb;7(1):44; discussion 49-50
Language
English
Publication Type
Article
Keywords
Anti-Arrhythmia Agents
Canada
Clinical Trials as Topic - standards
Drugs, Investigational
Humans
PubMed ID
2025791 View in PubMed
Less detail

Canada's Food and Drugs Act: is it really doing the job it was set up to do?

https://arctichealth.org/en/permalink/ahliterature242251
Source
Can Nurse. 1983 Feb;79(2):25-6
Publication Type
Article
Date
Feb-1983
Author
L. Charbonneau
Source
Can Nurse. 1983 Feb;79(2):25-6
Date
Feb-1983
Language
English
Publication Type
Article
Keywords
Canada
Clinical Trials as Topic - standards
Humans
Legislation, Drug
PubMed ID
6549908 View in PubMed
Less detail

Canadian Association for Immunization Research and Evaluation (CAIRE) guidelines for industry-sponsored clinical trial and epidemiology contract research.

https://arctichealth.org/en/permalink/ahliterature167238
Source
Hum Vaccin. 2005 Jul-Aug;1(4):140-2
Publication Type
Article
Author
Scott A Halperin
David Scheifele
Bernard Duval
Barbara Law
Brian Ward
Gordean Bjornson
Beth Halperin
Danuta Skowronski
Arlene King
Greg Hammond
Simon Dobson
Susan Tamblyn
Elaine Wang
Pierre Lavigne
Lisa Danzig
Donald Elrick
Elspeth Carnan
James Mansi
Francoise Bertrand
Laszlo Palkonyay
Gail Clements
Neil Maresky
David Wortzman
Author Affiliation
CAIRE Research Sponsor Advisory Board, Halifax, Nova Scotia. scott.halperin@dal.ca
Source
Hum Vaccin. 2005 Jul-Aug;1(4):140-2
Language
English
Publication Type
Article
Keywords
Canada
Clinical Protocols
Clinical Trials as Topic - standards
Data Interpretation, Statistical
Drug Industry - standards
Humans
Immunization - standards
Publications
Research - standards
Terminology as Topic
Abstract
In response to concerns about interactions of academic and public health investigators with industry, the Canadian Association for Immunization Research and Evaluation (CAIRE), in collaboration with six major vaccine manufacturers, developed guidelines for participation in industry-sponsored clinical trial and epidemiology contract research within Canada. Topics addressed include definition of investigators, data ownership, protocol development, data management, data analysis, producing a study report and publication of the results of the study.
PubMed ID
17012864 View in PubMed
Less detail

Canadian researchers performing world-class research.

https://arctichealth.org/en/permalink/ahliterature145867
Source
Can J Surg. 2010 Feb;53(1):4-5
Publication Type
Article
Date
Feb-2010
Author
Edward J Harvey
Source
Can J Surg. 2010 Feb;53(1):4-5
Date
Feb-2010
Language
English
French
Publication Type
Article
Keywords
Awards and Prizes
Biomedical Research - standards
Canada
Clinical Trials as Topic - standards
Humans
International Cooperation
United States
Notes
Cites: Injury. 2009 Nov;40(11):1131-619386310
PubMed ID
20100405 View in PubMed
Less detail

[Can Swedish clinical trials keep the world-wide leading position?].

https://arctichealth.org/en/permalink/ahliterature204690
Source
Lakartidningen. 1998 Aug 5;95(32-33):3398
Publication Type
Article
Date
Aug-5-1998
Author
G. Anstrén
Source
Lakartidningen. 1998 Aug 5;95(32-33):3398
Date
Aug-5-1998
Language
Swedish
Publication Type
Article
Keywords
Clinical Competence
Clinical Trials as Topic - standards
Ethics Committees
Humans
Societies, Pharmaceutical
Sweden
PubMed ID
9725951 View in PubMed
Less detail

[Clinical drug trials. Regulation, coordination and significance of "Good Clinical Practice"].

https://arctichealth.org/en/permalink/ahliterature218854
Source
Ugeskr Laeger. 1994 Feb 7;156(6):789-93
Publication Type
Article
Date
Feb-7-1994
Author
E F Hvidberg
Author Affiliation
Klinisk farmakologisk afdeling, Rigshospitalet, København.
Source
Ugeskr Laeger. 1994 Feb 7;156(6):789-93
Date
Feb-7-1994
Language
Danish
Publication Type
Article
Keywords
Clinical Trials as Topic - standards
Denmark
Drug Approval
Drug Evaluation
Drug and Narcotic Control
Drugs, Investigational
Ethics, Medical
Humans
International Cooperation
Abstract
All major drug agencies in the world have now implemented, or have at least shown interest in, Good Clinical Practice (GCP) standards as an important part of their regulation of clinical trials. This is increasingly considered as a logical part of drug regulation in general, because the data produced in trials will later be evaluated by the government agencies, and the quality of trials and data must therefore be assured. Another significant effect of GCP will be caused by the ties between ethics, public health and scientific standard referred to in many of the requirements. This means that GCP may eventually have an impact on the entire clinical research programme, including nonregulatory projects (possibly the majority), because the same standard must apply throughout. Harmonisation is well under way internationally for both GCP and clinical trial regulation. This should also extend to the handling of scientific misconduct, the influence of GCP on health economics and the establishment of ethics committee systems. International data bases may obviously be required. Finally, the ultimate goal, the benefit for patients and society, must not be obscured by the mechanics of improving clinical trials and the harmonisation of regulations, and the investigator should maintain a key position in clinical drug development under the new regulatory conditions.
PubMed ID
8016980 View in PubMed
Less detail

[Cooperation on systematic analysis of treatment effects].

https://arctichealth.org/en/permalink/ahliterature219409
Source
Nord Med. 1994;109(8-9):244-5
Publication Type
Article
Date
1994
Author
P C Gøtzsche
Author Affiliation
Det Nordiske Cochrane Center, Forsknings- og Udviklingssekretariatet, Rigshospitalet, København.
Source
Nord Med. 1994;109(8-9):244-5
Date
1994
Language
Danish
Publication Type
Article
Keywords
Canada
Clinical Trials as Topic - standards
Databases, Factual
Great Britain
Health Services Misuse
Health Services Research - standards
Humans
Scandinavia
PubMed ID
7937036 View in PubMed
Less detail

62 records – page 1 of 7.