IMAGING OF PHARMACODYNAMIC END POINTS IN CLINICAL TRIALS

2006 ◽  
pp. 299-336
Author(s):  
ERIC O. ABOAGYE ◽  
PATRICIA M. PRICE ◽  
A.R. Padhani
Keyword(s):  
Clinical Trials ◽  
End Points

A systematic review of noninferiority margins in oncology clinical trials

2021 ◽  
Vol 10 (6) ◽  
pp. 443-455
Author(s):  
Mahmoud Hashim ◽  
Talitha Vincken ◽  
Florint Kroi ◽  
Samron Gebregergish ◽  
Mike Spencer ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Absolute Rate ◽  
Time To Event ◽  
End Points ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
Noninferiority Trials ◽  
Oncology Clinical Trials ◽  
Noninferiority Margin

Aim: A systematic literature review was conducted to identify and characterize noninferiority margins for relevant end points in oncology clinical trials. Materials & methods: Randomized, controlled, noninferiority trials of patients with cancer were identified in PubMed and Embase. Results: Of 2284 publications identified, 285 oncology noninferiority clinical trials were analyzed. The median noninferiority margin was a hazard ratio of 1.29 (mean: 1.32; range: 1.05–2.05) for studies that reported time-to-event end points (n = 192). The median noninferiority margin was 13.0% (mean: 12.7%; range: 5.0–20.0%) for studies that reported response end points as absolute rate differences (n = 31). Conclusion: Although there was consistency in the noninferiority margins’ scale, variability was evident in noninferiority margins across trials. Increased transparency may improve consistency in noninferiority margin application in oncology clinical trials.

scholarly journals Variability and lack of predictive ability of asthma end-points in clinical trials

2002 ◽  
Vol 20 (5) ◽  
pp. 1102-1109 ◽  
Author(s):  
J. Zhang ◽  
C. Yu ◽  
S.T. Holgate ◽  
T.F. Reiss
Keyword(s):  
Clinical Trials ◽  
Predictive Ability ◽  
End Points

scholarly journals Evaluation of End Points in Cancer Clinical Trials

2018 ◽  
Vol 13 (6) ◽  
pp. 745-747 ◽  
Author(s):  
Jun Yin ◽  
Suzanne E. Dahlberg ◽  
Sumithra J. Mandrekar
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
End Points

Clinical Trial Design and Statistics

2018 ◽  
Author(s):  
Julie Ann Sosa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Analysis ◽  
Trial Design ◽  
New Technologies ◽  
Drug Application ◽  
Clinical Trial Design ◽  
Double Blind Study ◽  
Type I ◽  
End Points

A clinical trial is a planned experiment designed to prospectively measure the efficacy or effectiveness of an intervention by comparing outcomes in a group of subjects treated with the test intervention with those observed in one or more comparable group(s) of subjects receiving another intervention.  Historically, the gold standard for a clinical trial has been a prospective, randomized, double-blind study, but it is sometimes impractical or unethical to conduct such in clinical medicine and surgery. Conventional outcomes have traditionally been clinical end points; with the rise of new technologies, however, they are increasingly being supplemented and/or replaced by surrogate end points, such as serum biomarkers. Because patients are involved, safety considerations and ethical principles must be incorporated into all phases of clinical trial design, conduct, data analysis, and presentation. This review covers the history of clinical trials, clinical trial phases, ethical issues, implementing the study, basic biostatistics for data analysis, and other resources. Figures show drug development and clinical trial process, and type I and II error. Tables list Food and Drug Administration new drug application types, and types of missing data in clinical trials. This review contains 2 highly rendered figures, 2 tables, and 38 references

scholarly journals End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain

2019 ◽  
Vol 3 (23) ◽  
pp. 3982-4001 ◽  
Author(s):  
Ann T. Farrell ◽  
Julie Panepinto ◽  
C. Patrick Carroll ◽  
Deepika S. Darbari ◽  
Ankit A. Desai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Patient Reported Outcomes ◽  
Cell Disease ◽  
End Points ◽  
Additional Clinical Trial ◽  
Patient Reported ◽  
The Brain

Abstract To address the global burden of sickle cell disease (SCD) and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to: patient-reported outcomes (PROs), pain (non-PROs), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the PROs, pain, and brain panels, as well as relevant findings and recommendations from the biomarkers panel. The panels identify end points, where there were supporting data, to use in clinical trials of SCD. In addition, the panels discuss where further research is needed to support the development and validation of additional clinical trial end points.

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