scholarly journals Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease

2017 ◽  
Vol 12 (1) ◽  
Author(s):  
Loukia M. Spineli ◽  
Eva Jenz ◽  
Anika Großhennig ◽  
Armin Koch
Keyword(s):  
Clinical Trial ◽  
Rare Disease ◽  
Randomized Clinical Trial ◽  
Trial Design ◽  
Critical Appraisal ◽  
Clinical Trial Design ◽  
Parallel Group

Value of Biomarker Expression for Randomized Clinical Trial Design: One (More) Missed Opportunity

2020 ◽  
Vol 38 (6) ◽  
pp. 649-651 ◽  
Author(s):  
Francisco E. Vera-Badillo ◽  
Andrew J. Robinson ◽  
David M. Berman ◽  
Christopher M. Booth
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Missed Opportunity

scholarly journals General concepts in biostatistics and clinical epidemiology: Experimental studies with randomized clinical trial design

Medwave ◽  
2020 ◽  
Vol 20 (03) ◽  
pp. e7869-e7869
Author(s):  
Sebastián Estrada ◽  
Marcelo Arancibia ◽  
Jana Stojanova ◽  
Cristian Papuzinski
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Design ◽  
Clinical Epidemiology ◽  
Experimental Studies ◽  
Clinical Trial Design

scholarly journals Use of a randomized clinical trial design to study cognitive rehabilitation approaches to enhance warfighter performance

2020 ◽  
Vol 20 ◽  
pp. 100660
Author(s):  
Ida Babakhanyan ◽  
Melissa Jensen ◽  
Rosemay A. Remigio-Baker ◽  
Paul Sargent ◽  
Jason M. Bailie
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cognitive Rehabilitation ◽  
Trial Design ◽  
Clinical Trial Design

Randomized Clinical Trial Design for Assessing Noninferiority When Superiority Is Expected

2007 ◽  
Vol 25 (31) ◽  
pp. 5019-5023 ◽  
Author(s):  
Boris Freidlin ◽  
Edward L. Korn ◽  
Stephen L. George ◽  
Robert Gray
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Tolerability Profile ◽  
Modest Improvement ◽  
Noninferiority Trials ◽  
New Treatment ◽  
Formal Test ◽  
Hybrid Trial

The randomized clinical trial (RCT) is the gold standard for definitive evaluation of new therapies. RCTs designed to show that the therapeutic efficacy of a new therapy is not unacceptably inferior to that of standard therapy are called noninferiority trials. Traditionally, noninferiority trials have required very large sample sizes. Sometimes, a new treatment regimen with a favorable toxicity and/or tolerability profile is also expected to have some modest improvement in efficacy. In such specialized settings we describe a hybrid trial-design approach that requires a dramatically smaller sample size than that of a standard noninferiority design. This hybrid design can naturally incorporate a formal test of superiority as well as noninferiority.

scholarly journals The Glaucoma Intensive Treatment Study (GITS), a randomized clinical trial: design, methodology and baseline data

2018 ◽  
Vol 96 (6) ◽  
pp. 557-566 ◽  
Author(s):  
Boel Bengtsson ◽  
Anders Heijl ◽  
Gauti Johannesson ◽  
Sabina Andersson-Geimer ◽  
Johan Aspberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Design ◽  
Design Methodology ◽  
Clinical Trial Design ◽  
Baseline Data ◽  
Intensive Treatment

scholarly journals The POWER-tool: Recommendations for involving patient representatives in choosing relevant outcome measures during rare disease clinical trial design

Health Policy ◽  
2018 ◽  
Vol 122 (12) ◽  
pp. 1287-1294 ◽  
Author(s):  
C.M.W. Gaasterland ◽  
M.C. Jansen-van der Weide ◽  
E. Vroom ◽  
K. Leeson-Beevers ◽  
M. Kaatee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rare Disease ◽  
Outcome Measures ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Patient Representatives ◽  
Rare Disease Clinical Trial ◽  
Relevant Outcome
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