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[Attitude of patient associations to clinical trials of new drugs].

https://arctichealth.org/en/permalink/ahliterature185277
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1688-90
Publication Type
Article
Date
Apr-14-2003
Author
Hanne Wendel Tybkjaer
Lene Witte
Mette Bruun Johannessen
Author Affiliation
Gigtforeningen, Gentoftegade 118, DK-2820 Gentofte.
Source
Ugeskr Laeger. 2003 Apr 14;165(16):1688-90
Date
Apr-14-2003
Language
Danish
Publication Type
Article
Keywords
Antirheumatic Agents - adverse effects - therapeutic use
Attitude to Health
Clinical Trials as Topic - legislation & jurisprudence - standards
Cystic Fibrosis - drug therapy
Denmark
Drug Monitoring - standards
Drugs, Investigational - adverse effects - therapeutic use
Humans
Organizations
Patient Education as Topic - legislation & jurisprudence - standards
Patient Rights - legislation & jurisprudence
Patients - legislation & jurisprudence - psychology
Practice Guidelines as Topic - standards
Research Subjects - legislation & jurisprudence - psychology
Rheumatic Diseases - drug therapy
Abstract
Both the Danish Rheumatism Association and the Danish Cystic Fibrosis Association think that patients have a right of access to new and better medicine. The patients affiliated to these two patient groups are more than willing to enroll in clinical trials on new drugs. The Danish Rheumatism Association focuses on good information and security while the Danish Cystic Fibrosis Association has an unrestricted willingness to enroll in clinical trials.
PubMed ID
12756833 View in PubMed
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Debate about placebos points to issue surrounded by many shades of grey.

https://arctichealth.org/en/permalink/ahliterature210566
Source
CMAJ. 1996 Nov 15;155(10):1475-6
Publication Type
Article
Date
Nov-15-1996
Author
N. Baer
Source
CMAJ. 1996 Nov 15;155(10):1475-6
Date
Nov-15-1996
Language
English
Publication Type
Article
Keywords
Attitude to Health
Canada
Control Groups
Controlled Clinical Trials as Topic - methods
Depression - therapy
Drugs, Investigational - adverse effects - therapeutic use
Ethics, Medical
Government Regulation
Humans
Mental Disorders - therapy
Mentally Ill Persons
Patient Selection
Placebos
Risk assessment
Therapeutic Human Experimentation
Abstract
Dr. Kenneth Rothman, a critic of the use of placebos in clinical trials, recently discussed the issue with Health Canada employees. Some researchers insist this is not a black-and-white issue, and that in some cases patients who receive a placebo are the lucky ones.
PubMed ID
8943938 View in PubMed
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Legal issues surrounding privately funded research cause furore in Toronto.

https://arctichealth.org/en/permalink/ahliterature203784
Source
CMAJ. 1998 Oct 20;159(8):983-6
Publication Type
Article
Date
Oct-20-1998
Author
M. Shuchman
Author Affiliation
Department of Psychiatry, State University of New York, Buffalo, USA.
Source
CMAJ. 1998 Oct 20;159(8):983-6
Date
Oct-20-1998
Language
English
Publication Type
Article
Keywords
Biomedical research
Canada
Clinical Trials as Topic - economics - legislation & jurisprudence - standards
Conflict of Interest
Contracts
Disclosure
Drugs, Investigational - adverse effects - therapeutic use
Hospitals, Pediatric
Hospitals, University
Humans
Information Dissemination
Iron Chelating Agents - adverse effects - therapeutic use
Iron Overload - drug therapy - etiology
Ontario
Publishing
Pyridones - adverse effects - therapeutic use
Research Support as Topic - legislation & jurisprudence
Treatment Failure
Truth Disclosure
beta-Thalassemia - complications
Abstract
Toronto physician Miriam Shuchman has spent the last 4 months tracking the research issues surrounding a controversial clinical trial conducted in Toronto. Much of the information appearing in this article was gathered while she was preparing a segment for the CBC Radio program Quirks and Quarks. Earlier, she had reported on similar issues in the US for the Annals of Internal Medicine.
Notes
Comment In: CMAJ. 1998 Oct 20;159(8):955-79834722
PubMed ID
9834727 View in PubMed
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Pediatric versus adult drug trials for conditions with high pediatric disease burden.

https://arctichealth.org/en/permalink/ahliterature122347
Source
Pediatrics. 2012 Aug;130(2):285-92
Publication Type
Article
Date
Aug-2012
Author
Florence T Bourgeois
Srinivas Murthy
Catia Pinto
Karen L Olson
John P A Ioannidis
Kenneth D Mandl
Author Affiliation
Division of Emergency Medicine, Children's Hospital Boston, 300 Longwood Ave, Boston, MA 02115, USA. florence.bourgeois@childrens.harvard.edu
Source
Pediatrics. 2012 Aug;130(2):285-92
Date
Aug-2012
Language
English
Publication Type
Article
Keywords
Adult
Age Factors
Child
Cost of Illness
Drug Industry - statistics & numerical data
Drugs, Investigational - adverse effects - therapeutic use
Evidence-Based Medicine - statistics & numerical data
Female
Humans
Male
Quality Indicators, Health Care - standards - statistics & numerical data
Randomized Controlled Trials as Topic - standards - statistics & numerical data
Research Support as Topic
Sweden
Treatment Outcome
Abstract
Optimal treatment decisions in children require sufficient evidence on the safety and efficacy of pharmaceuticals in pediatric patients. However, there is concern that not enough trials are conducted in children and that pediatric trials differ from those performed in adults. Our objective was to measure the prevalence of pediatric studies among clinical drug trials and compare trial characteristics and quality indicators between pediatric and adult drug trials.
For conditions representing a high burden of pediatric disease, we identified all drug trials registered in ClinicalTrials.gov with start dates between 2006 and 2011 and tracked the resulting publications. We measured the proportion of pediatric trials and subjects for each condition and compared pediatric and adult trial characteristics and quality indicators.
For the conditions selected, 59.9% of the disease burden was attributable to children, but only 12.0% (292/2440) of trials were pediatric (P
Notes
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PubMed ID
22826574 View in PubMed
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