While clinicians are the top choice for learning about clinical trials, they have little or no training and little time for this role. As we move toward integrating clinical trials into the practice setting, these issues of time, training, and resources must be addressed....
Risks There are always certain risks or side effects to clinical trials. There may be unpleasant, serious or even life-threatening side effects to experimental treatment. The experimental treatment may not be effective for the participant. The protocol may require more of their time and attention...
Phase IVclinical trials, also called post-marketing studies, are conducted after a treatment has been approved. The purpose of these trials is to provide an opportunity to learn more details about the treatment and to address questions that may have come up during other phases of trials. This ...
from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols.The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation...
Once through the gauntlet of scientific and ordinary hazards of biotech research and development, firms involoved in clinical trials, still years away from selling a product in the general marketplace, run the risk of product liability suits for injury to test subjects. These firms must be ...
A clinical trial is defined as a controlled trial in humans of new drugs, devices, therapy or diagnosis, or comparisonsDr. Albena Zlatareva
To the Editor: The study of trends in risksand benefits to patients with cancer in phase 1 clinical trials by Dr Robertsand colleagues1 was noted to be the first analysisof phase 1 cancer trials in the era of targeted therapy. As such, I wouldbe interested to know why an analysis of ...
- 《International Reviews of Immunology》 被引量: 44发表: 2009年 Gene therapy researchers' assessments of risks and perceptions of risk acceptability in clinical trials. Although recent clinical trials have demonstrated the increasing promise of gene therapy, they have also illustrated the difficulties ...
Clinical trials of cardiovascular gene therapy, whether using viral (53%) or nonviral (47%) vectors, have thus far disclosed no evidence indicative of infl... J,M,Isner,... - 《Circulation Research》 被引量: 321发表: 2001年 ubclinical Hypothyroidism Is Associated With Increased Risk for Al...
SJ Andriole,SM Halpin - 《Archives of Disease in Childhood》 被引量: 9发表: 1991年 Balancing benefit against risk in the choice of therapy for coronary artery disease. Lesson from prospective, randomized, clinical trials of percutaneous coronary intervention and coronary artery bypass graft surgery ...