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Clinical Trials, Phase I as Topic - Statistics & numerical data
Research News and Information
Definition of 'Clinical Trials, Phase I as Topic'Studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries. |
Monday, November 23, 2009
The k-in-a-row up-and-down design, revisited.
13 Jun 2009 
The percentile-finding experimental design known variously as 'forced-choice fixed-staircase', 'geometric up-and-down' or 'k-in-a-row' (KR) was introduced by Wetherill four decades ago. To date, KR has been by far the most widely used up-and-down ... Read more...
Clinical benefit in Phase-I trials of novel molecularly targeted agents: does dose matter?
3 May 2009 Phase-I trials traditionally involve dose-escalation to determine the maximal tolerated dose (MTD). With conventional chemotherapy, efficacy is generally deemed to be dose-dependent, but the same may not be applicable to molecularly targeted agents ... Read more...
Sequential designs for ordinal phase I clinical trials.
30 Mar 2009 Sequential designs for phase I clinical trials which incorporate maximum likelihood estimates (MLE) as data accrue are inherently problematic because of limited data for estimation early on. We address this problem for small phase I clinical trials ... Read more...
Latest indexed articles for 'Clinical Trials, Phase I as Topic - Statistics & numerical data'
These are the very latest articles for this heading:
- The k-in-a-row up-and-down design, revisited. 13 Jun 2009
- Clinical benefit in Phase-I trials of novel molecularly targeted agents: does dose matter? 3 May 2009
- Sequential designs for ordinal phase I clinical trials. 30 Mar 2009
- Model-based decision making in early clinical development: minimizing the impact of a blood pressure adverse event. 4 Feb 2009
- TCR transgenes and transgene cassettes for TCR gene therapy: status in 2008. Feb 2009
- Some notable properties of the standard oncology Phase I design. 30 Dec 2008
- Design issues in dose-finding Phase I trials for combinations of two agents. 30 Dec 2008
- A Bayesian case study in oncology Phase I combination dose-finding using logistic regression with covariates. 30 Dec 2008
- Continual reassessment method vs. traditional empirically based design: modifications motivated by Phase I trials in pediatric oncology by the Pediatric Brain Tumor Consortium. 30 Dec 2008
- The utility of microdosing over the past 5 years. 29 Nov 2008
- Is there a role for herbal medicine in the treatment of pancreatic cancer?. Highlights from the "44th ASCO Annual Meeting". Chicago, IL, USA. May 30 - June 3, 2008.
8 Jul 2008 - Trans-sodium crocetinate for treating hypoxia/ischemia. 30 May 2008
- Three-dose-cohort designs in cancer phase I trials. 28 May 2008
- Mesenchymal stem cells for graft-versus-host disease: a double edged sword?
28 Feb 2008 - A SAS-based solution to evaluate study design efficiency of phase I pediatric oncology trials via discrete event simulation. 11 Feb 2008
- Population pharmacokinetics of cetuximab in patients with squamous cell carcinoma of the head and neck. 22 Jan 2008
- A comprehensive comparison of the continual reassessment method to the standard 3 + 3 dose escalation scheme in Phase I dose-finding studies. 30 Dec 2007
- A method for constructing and estimating the RR-memory of the QT-interval and its inclusion in a multivariate biomarker for torsades de pointes risk. 30 Dec 2007
- Modeling attainment of steady state of drug concentration in plasma by means of a Bayesian approach using MCMC methods. 30 Dec 2007
- A parallel phase I/II clinical trial design for combination therapies. 30 May 2007
See a longer list of these articles.
Technical information about 'Clinical Trials, Phase I as Topic'
Definition: Studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
Descriptor UI: D017321
Alternative terms: Clinical Trials, Phase I as Topic; Clinical Trials, Phase I; Phase 1 Clinical Trials; Phase I Clinical Trials; Clinical Trials, Phase 1; Evaluation Studies, FDA Phase I; Evaluation Studies, FDA Phase 1; Microdosing Trials, Human; Human Microdosing Trial; Microdosing Trial, Human; Trial, Human Microdosing; Trials, Human Microdosing; Human Microdosing Trials; Drug Evaluation, FDA Phase I as Topic; Drug Evaluation, FDA Phase I; Drug Evaluation, FDA Phase 1;
Related Mesh Headings: Nontherapeutic Human Experimentation;
Allowable Qualifiers: adverse effects; classification; economics; history; instrumentation; methods; mortality; nursing; psychology; standards; trends; utilization; veterinary; statistics & numerical data; contraindications; ethics; legislation & jurisprudence;
Tree Number: E05.318.760.535.200; E05.337.250.200; N05.715.360.775.235.200; N06.850.520.450.535.200;
History Note: 2008(1993)
Technical Notes: for general design, methodology, economics, etc. of phase I clinical trials; a different heading CLINICAL TRIAL, PHASE I is used for reports of a specific phase I clinical trial