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.
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.
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.
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