Outcome of patients with relapsed or progressive Ewing sarcoma enrolled on cooperative group phase 2 clinical trials: A report from the Children's Oncology Group

2021 ◽  
Author(s):  
Anderson B. Collier ◽  
Mark D. Krailo ◽  
Ha M. Dang ◽  
Steven G. DuBois ◽  
Douglas S. Hawkins ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ewing Sarcoma ◽  
Cooperative Group ◽  
Phase 2 ◽  
Oncology Group ◽  
Phase 2 Clinical Trials

scholarly journals GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies—reporting of phase 1 and phase 2 clinical trials

2005 ◽  
Vol 7 (4) ◽  
pp. 425-434 ◽  
Author(s):  
Susan M. Chang ◽  
Sharon L. Reynolds ◽  
Nicholas Butowski ◽  
Kathleen R. Lamborn ◽  
Jan C. Buckner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 1 ◽  
Phase 2 ◽  
Phase 2 Clinical Trials

scholarly journals Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

2010 ◽  
Vol 52 (10) ◽  
pp. 875-881 ◽  
Author(s):  
I. J. van den Elskamp ◽  
B. Boden ◽  
V. Dattola ◽  
D. L. Knol ◽  
M. Filippi ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Outcome Measure ◽  
Cerebral Atrophy ◽  
Phase 2 ◽  
Short Term ◽  
Phase 2 Clinical Trials

Low Dose (12 Gy) Total Skin Electron Beam Therapy (TSEBT) for Mycosis Fungoides (mf): Results of Three Phase 2 Clinical Trials

2014 ◽  
Vol 90 (1) ◽  
pp. S151
Author(s):  
R.T. Hoppe ◽  
C. Harrison ◽  
M. Tavallaee ◽  
S. Bashey ◽  
S. Li ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Electron Beam ◽  
Mycosis Fungoides ◽  
Low Dose ◽  
Phase 2 ◽  
Electron Beam Therapy ◽  
Three Phase ◽  
Phase 2 Clinical Trials

Survival following the documentation of platinum and taxane resistance in ovarian cancer: a single institution experience involving multiple phase 2 clinical trials

2004 ◽  
Vol 93 (3) ◽  
pp. 699-701 ◽  
Author(s):  
M MARKMAN ◽  
K WEBSTER ◽  
K ZANOTTI ◽  
G PETERSON ◽  
B KULP ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trials ◽  
Phase 2 ◽  
Single Institution ◽  
Multiple Phase ◽  
Taxane Resistance ◽  
Phase 2 Clinical Trials

New designs for phase 2 clinical trials

Blood ◽  
2003 ◽  
Vol 102 (2) ◽  
pp. 442-448 ◽  
Author(s):  
Elihu H. Estey ◽  
Peter F. Thall
Keyword(s):  
Clinical Trials ◽  
Treatment Effect ◽  
Binary Response ◽  
Phase 2 ◽  
Phase 3 ◽  
Trial Effect ◽  
Number Of Patients ◽  
Binary Response Variable ◽  
Subsequent Phase ◽  
Phase 2 Clinical Trials

AbstractConventional phase 2 clinical trials are typically single-arm experiments, with outcome characterized by one binary “response” variable. Clinical investigators are poorly served by such conventional methodology. We contend that phase 2 trials are inherently comparative, with the results of the comparison determining whether to conduct a subsequent phase 3 trial. When different treatments are studied in separate single-arm trials, actual differences between response rates associated with the treatments, “treatment effects,” are confounded with differences between the trials, “trial effects.” Thus, it is impossible to estimate either effect separately. Consequently, when the results of separate single-arm trials of different treatments are compared, an apparent treatment difference may be due to a trial effect. Conversely, the apparent absence of a treatment effect may be due to an actual treatment effect being cancelled out by a trial effect. Because selection involves comparison, single-arm phase 2 trials thus fail to provide a reliable means for selecting which therapies to investigate in phase 3. Moreover, reducing complex clinical phenomena, including both adverse and desirable events, to a single outcome wastes important information. Consequently, conventional phase 2 designs are inefficient and unreliable. Given the limited number of patients available for phase 2 trials and the increasing number of new therapies that must be evaluated, it is critically important to conduct these trials efficiently. These concerns motivated the development of a general paradigm for randomized selection trials evaluating several therapies based on multiple outcomes. Three illustrative applications of trials using this approach are presented.

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