Clinical Trial Experience With the 9-Valent HPV Vaccine by Race/Ethnicity: A Combined Analysis from Seven Phase III Clinical Studies

The treatment of relapsed multiple myeloma remains challenging. Based on interim data from the randomized Phase III IKEMA study demonstrating a progression-free survival benefit with a combination of isatuximab (Isa, a CD38-targeted monoclonal antibody) and carfilzomib/dexamethasone (Kd) versus Kd alone, Isa-Kd recently received regulatory approval in the USA and Europe for patients with multiple myeloma who have received at least one prior line of therapy (in the USA, up to three prior lines). In this review we discuss the rationale and clinical trial experience to date with Isa-Kd. Although final IKEMA results are pending, Isa-Kd has emerged as an effective and tolerable therapy for patients with relapsed multiple myeloma. Given the growing number of antibody-containing triplet regimens in this setting, potential niches and limitations for Isa-Kd are also discussed.

Download Full-text

Assessing the ability of boys with Duchenne muscular dystrophy age 4–7 years to swallow softgel capsules: Clinical trial experience with edasalonexent

Journal of Clinical Pharmacy and Therapeutics ◽

10.1111/jcpt.13478 ◽

2021 ◽

Author(s):

Maria Mancini ◽

Gigi Shafai ◽

Elizabeth Thaler ◽

Joanne M. Donovan ◽

Richard S. Finkel

Keyword(s):

Clinical Trial ◽

Duchenne Muscular Dystrophy ◽

Muscular Dystrophy ◽

Trial Experience ◽

Clinical Trial Experience

Download Full-text

SB623 Preclinical and Clinical Trial Experience

Cellular and Molecular Approaches to Regeneration and Repair - Springer Series in Translational Stroke Research ◽

10.1007/978-3-319-66679-2_14 ◽

2017 ◽

pp. 281-292

Author(s):

Eric S. Sussman ◽

Gary K. Steinberg

Keyword(s):

Clinical Trial ◽

Trial Experience ◽

Clinical Trial Experience

Download Full-text

The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

Journal of Cerebral Blood Flow & Metabolism ◽

10.1177/0271678x18760109 ◽

2018 ◽

Vol 38 (5) ◽

pp. 749-754 ◽

Cited By ~ 1

Author(s):

Olivia Kiwanuka ◽

Bo-Michael Bellander ◽

Anders Hånell

Keyword(s):

Clinical Trial ◽

Traumatic Brain Injury ◽

Clinical Trials ◽

Brain Injury ◽

Network Analysis ◽

Clinical Studies ◽

Phase Iii ◽

Phase Iii Clinical Trial ◽

Phase Iii Clinical Trials ◽

Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

Download Full-text