scholarly journals Incorporating adverse event relatedness into dose-finding clinical trial designs

2013 ◽  
Vol 33 (7) ◽  
pp. 1146-1161 ◽  
Author(s):  
Darsy Darssan ◽  
Mery H. Thompson ◽  
Anthony N. Pettitt
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Dose Finding ◽  
Clinical Trial Designs

scholarly journals Proportional odds model for dose-finding clinical trial designs with ordinal toxicity grading

2011 ◽  
Vol 30 (17) ◽  
pp. 2070-2080 ◽  
Author(s):  
Emily M. Van Meter ◽  
Elizabeth Garrett-Mayer ◽  
Dipankar Bandyopadhyay
Keyword(s):  
Clinical Trial ◽  
Proportional Odds Model ◽  
Dose Finding ◽  
Proportional Odds ◽  
Clinical Trial Designs

scholarly journals Brivaracetam: a newly approved medication for epilepsy

2019 ◽  
Vol 14 (3) ◽  
pp. FNL23
Author(s):  
Joel M Oster
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Dose Finding ◽  
Adjunctive Treatment ◽  
Adverse Event Profile ◽  
Focal Seizures ◽  
The Usa ◽  
Clinical Trial Program ◽  
The Eu

Brivaracetam (BRV) in both the USA and EU was developed as a novel molecule for the adjunctive treatment of partial-onset (focal) seizures in patients ≥16 years of age and as of September 2017 was approved for use as monotherapy in the USA uniquely as an antiseizure medication that may be prescribed without a dose finding uptitration. This article reviews BRV's pharmacology, efficacy, safety and adverse event profiles, along with the relevant and noted regulatory hurdles in the USA and the EU. Available postmarketing data will also be summarized. Approximately 3000 patients were studied over about 9 years in the clinical trial program illustrating that BRV has efficacy at 50–200 mg/day with an acceptable adverse event profile.

Clinical Trial Designs for the Early Clinical Development of Therapeutic Cancer Vaccines

2001 ◽  
Vol 19 (6) ◽  
pp. 1848-1854 ◽  
Author(s):  
Richard M. Simon ◽  
Seth M. Steinberg ◽  
Michael Hamilton ◽  
Allan Hildesheim ◽  
Samir Khleif ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Vaccines ◽  
Chemotherapeutic Agents ◽  
Clinical Development ◽  
Dose Finding ◽  
Tumor Vaccines ◽  
Wide Range ◽  
Clinical Trial Designs ◽  
Therapeutic Cancer Vaccines

ABSTRACT: There are major differences between therapeutic tumor vaccines and chemotherapeutic agents that have important implications for the design of early clinical trials. Many vaccines are inherently safe and do not require phase I dose finding trials. Patients with advanced cancers and compromised immune systems are not good candidates for assessing either the toxicity or efficacy of therapeutic cancer vaccines. The rapid pace of development of new vaccine candidates and the variety of possible adjuvants and modifications in method of administration makes it important to use efficient designs for clinical screening and evaluation of vaccine regimens. We review the potential advantages of a wide range of clinical trial designs for the development of tumor vaccines. We address the role of immunological endpoints in early clinical trials of tumor vaccines, investigate the design implications of attempting to use disease stabilization as an end point and discuss the difficulties of reliably utilizing historical control data. Several conclusions for expediting the clinical development of effective cancer vaccines are proposed.

scholarly journals P119: Pain free laceration repairs using intra-nasal ketamine: DosINK 1- A dose escalation clinical trial

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S99-S99
Author(s):  
S. Rached-dastous ◽  
B. Bailey ◽  
C. Marquis ◽  
M. Desjardins ◽  
D. Lebel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Dose Escalation ◽  
Optimal Dose ◽  
Dose Finding ◽  
Procedural Sedation ◽  
Secondary Outcome ◽  
Finding Study ◽  
Baseline Status ◽  
Set Up

Introduction: Laceration is common in children presenting to the emergency department (ED). They are often uncooperative related to pain and distressed during repair. Currently, there are wide variations regarding sedation and analgesia practices when sutures are required. There is a growing interest in the intranasal (IN) route for procedural sedation and pain control because of its effectiveness potential and ease of administration. Few studies have evaluated IN ketamine for procedural sedation in children with reported doses ranging from 3 to 9 mg/kg. The objective is to evaluate the optimal IN ketamine dose for effective and safe procedural sedation for laceration repair in children aged 1 to 12 years. Methods: A dose escalation clinical trial with an initial dose of 3 mg/kg of IN ketamine up to a maximum dose of 9 mg/kg in children 1 to 12 years old, using a 3+3 trial design. For each tested dose, 3 patients are enrolled. Escalation to the next dose is permitted if sedation is unsuccessful in at least one patient without serious adverse event (SAE). Regression to prior dose is warranted in the occurrence of two or more SEAs. This process is repeated until effective sedation for 6 patients at two consecutive doses is achieved with a maximum of 1 SAE or if regression occurs. The primary outcome is the optimal dose for successful procedural sedation as per the PERC/PECARN consensus criteria. Secondary outcome, namely, pain and anxiety levels, parent, patient and provider satisfaction, recovery time, length of stay in the ED, side effects and adverse event are recorded. Results: Nine patients have been recruited from March to December 2017 with median age of 2.9 years-old and with laceration length of 2 to 5 cm and with facial involvement in 55% of cases, respectively. Sedation was successful in 1/3, 1/3 and 3/3 of patients at doses of 3, 4, 5 mg/kg respectively, without any SAE. Median time from ketamine administration to return to baseline status and discharge were 35 and 98 min, respectively. We expect to complete patient recruitment in March 2018. Conclusion: The results from our trial is a groundwork for future dose-finding study. Pending study completion, a multicentric dose validation trial, is set up to further validate the optimal dose from dosINK1 trial. IN ketamine has the potential to improve the field of procedural sedation for children by introducing an effective IN agent with respiratory stability but without the need for an IV line insertion not otherwise needed.

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

Efficacy and Tolerability of Tratinterol Hydrochloride Tablets in Bronchial Asthma: A Multicenter, Randomized, Double-blind, Dose-finding Clinical Trial

2014 ◽  
Vol 36 (9) ◽  
pp. 1195-1204 ◽  
Author(s):  
Lingfei Kong ◽  
Yuan Yuan ◽  
Yuxia Shao ◽  
Shenghua Sun ◽  
Jiaming Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bronchial Asthma ◽  
Dose Finding ◽  
Double Blind
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