Points in phase 1 clinical trials.
نویسندگان
چکیده
منابع مشابه
Novel designs and end points for phase II clinical trials.
The large number of negative phase III trials in oncology over the last several years has renewed interest in refining phase II oncology clinical trials to maximize the chances of success in phase III testing. More efficient phase II study designs will improve our ability to identify promising agents for testing while accurately identifying nonefficacious agents. Recognizing that new paradigms ...
متن کاملComposite end points in clinical trials.
Composite endpoints are often used in clinical trials, especially in the cardiovascular area. Decreases in sample size requirements, ability to assess the net effect of an intervention and to avoid bias in presence of competing risk are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, nu...
متن کاملClinical End Points in Coronary Stent Trials
Background—Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. Methods and Results—The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in ...
متن کاملPhase I clinical trials
Phase I trials are conducted to find a dose to use in subsequent trials. They provide data on the rate of adverse events at different dose levels and provide data for studying the pharmacokinetics and pharmacology of the drug. Dose-finding studies that involve therapies with little or no toxicity often enroll healthy volunteers and usually have a control group. Trials in oncology and other life...
متن کاملPrivacy-Preserving Patient Tracking for Phase 1 Clinical Trials
ii Abstract . Electronic data has become the standard method of storing information in our modern age. Evolving from paper-based data to electronic data creates opportunities to share information between organizations in record speeds, especially when handling large data sets. However, sharing sensitive information creates requirements for electronic data exchange: privacy requires that the ori...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
سال: 1995
ISSN: 1882-8272,0388-1601
DOI: 10.3999/jscpt.26.607