scholarly journals Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA

Bioanalysis ◽  
2020 ◽  
Vol 12 (19) ◽  
pp. 1363-1375
Author(s):  
Katrina M Nolan ◽  
Yuhua Zhang ◽  
Joseph M Antonello ◽  
Adrienne H Howlett ◽  
Cyrille J Bonhomme ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conjugate Vaccine ◽  
Threshold Value ◽  
Phase Iii ◽  
Capsular Polysaccharides ◽  
Acceptance Criteria ◽  
Phase Iii Clinical Trial ◽  
Assay Validation ◽  
Clinical Trial Program

Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. Results: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. Conclusion: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.

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

2018 ◽  
Vol 38 (5) ◽  
pp. 749-754 ◽  
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.

scholarly journals Obtaining Valid Laboratory Data in Clinical Trials Conducted in Resource Diverse Settings: Lessons Learned from a Microbicide Phase III Clinical Trial

PLoS ONE ◽  
2010 ◽  
Vol 5 (10) ◽  
pp. e13592 ◽  
Author(s):  
Tania Crucitti ◽  
Katrien Fransen ◽  
Rashika Maharaj ◽  
Tom Tenywa ◽  
Marguerite Massinga Loembé ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Laboratory Data ◽  
Lessons Learned ◽  
Phase Iii ◽  
Phase Iii Clinical Trial

scholarly journals Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care

2021 ◽  
pp. 135245852098511
Author(s):  
Kris Oliver Jalusic ◽  
David Ellenberger ◽  
Paulus Rommer ◽  
Alexander Stahmann ◽  
Uwe Zettl ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Care ◽  
Routine Care ◽  
Phase Iii ◽  
Exclusion Criteria ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Multiple Sclerosis Patients

Background: Newly approved, drug-modifying therapies are associated with still unknown adverse events, although clinical trials leading to approval have strict inclusion and exclusion criteria and analyse safety and efficacy. Objectives: The aim of this study was to analyse the eligibility of multiple sclerosis (MS) patients treated in routine care into the phase III clinical trial of the respective drug. Methods: In total, 3577 MS patients with 4312 therapies were analysed. Patients with primary-progressive MS were excluded. Inclusion and exclusion criteria of phase III clinical trials in relapsing–remitting MS were adopted and subsequently applied. A comparison in clinical and sociodemographic characteristics was made between patient who met the criteria and those who did not. Results: 83% of registered patients would not have been eligible to the respective phase III clinical trial. Relapse was the single most frequent criterion not fulfilled (74.7%), followed by medication history (21.2%). Conclusion: The majority of MS patients treated in routine care would not have met clinical trials criteria. Thus, the efficacy and safety of therapies in clinical trials can differ from those in the real world. Broader phase III inclusion criteria would increase their eligibility and contribute to a better generalizability of the results in clinical trials.

Tocilizumab for rheumatoid arthritis: results of the Phase III clinical trial program

2011 ◽  
Vol 1 (2) ◽  
pp. 345-354
Author(s):  
Javier Rueda ◽  
Miguel A González-Gay ◽  
Ricardo Blanco
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Clinical Trial Program
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