Abstract ES3-4: Clinical Trial Designs for New Therapies: When Should We Randomize?

2012 ◽  
Author(s):  
S Hunsberger
Keyword(s):  
Clinical Trial ◽  
New Therapies ◽  
Clinical Trial Designs

The future of multiple sclerosis therapies: redesigning multiple sclerosis clinical trials in a new therapeutic eraa

2005 ◽  
Vol 11 (6) ◽  
pp. 669-676 ◽  
Author(s):  
H F McFarland ◽  
S C Reingold
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Controlled Trial ◽  
International Workshop ◽  
Regulatory Approval ◽  
Ethical Considerations ◽  
New Therapies ◽  
Clinical Trial Designs ◽  
New Strategies

Due to past success in testing and gaining regulatory approval for a variety of therapies in multiple sclerosis (MS), the conduct of future clinical trials has become increasingly problematic. An international workshop has met to discuss the issues facing the MS clinical trial community and to examine possible new strategies for the design of trials. Particular focus has been placed on trials that either avoid the use of a placebo because of ethical considerations or on designs that allow new therapies to be studied more rapidly or with fewer patients than needed in a conventional placebo-controlled trial. The discussions resulting from the workshop should provide a basis for the examination and implementation of innovative clinical trial designs in MS.

scholarly journals New clinical trial designs for HIV vaccine evaluation

2013 ◽  
Vol 8 (5) ◽  
pp. 437-442 ◽  
Author(s):  
Zoe Moodie ◽  
Holly Janes ◽  
Yunda Huang
Keyword(s):  
Clinical Trial ◽  
Hiv Vaccine ◽  
Clinical Trial Designs

Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient

2021 ◽  
Vol 16 ◽  
Author(s):  
Erica Winter ◽  
Scott Schliebner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Rare Disease ◽  
Rare Diseases ◽  
Statistical Analyses ◽  
Clinical Trial Designs ◽  
Novel Approaches

: Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. In recent years, there have been increased efforts by stakeholders to improve drug development in rare diseases through novel approaches to clinical trial designs and statistical analyses. We highlight and discuss some of the current and emerging approaches aimed at overcoming challenges in rare disease clinical trials, with a focus on the ultimate stakeholder, the patient.

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