Monday, January 19, 2015

Dose Limiting Toxicity (DLT) and Common Toxicity Criteria (CTC) / Common Terminology Criteria for Adverse Events (CTCAE)

›
For the early clinical phase trials, especially first-in-man oncology studies, the major objective is usually to identify a safe dose, such...
4 comments:
Wednesday, January 07, 2015

Alternative phase I dose escalation study designs: CRM, BLRM, mTPI, and PGDE

›
The " 3 + 3 design " is the most commonly used design in phase I dose escalation study and over 95% of phase I clinical trials in ...
1 comment:
Sunday, January 04, 2015

Phase I Dose Escalation Study Design: "3 + 3 Design"

›
For the first-in-human clinical trial, the dose escalation study design is often utilized. in dose escalation study, subjects are enrolled i...
5 comments:
Saturday, December 06, 2014

Clinical trial design for treatment of Ebola virus disease versus Ebola vaccine

›
Ebola outbreak in West Africa has brought a lot of attentions to this deadly virus. The world is so unprepared for the Ebola treatment and...
1 comment:
Monday, December 01, 2014

FDA's Priority Review Voucher Programs

›
A voucher is a bond of the redeemable transaction type which is worth a certain monetary value and which may be spent only for specific reas...
Monday, November 24, 2014

FDA's Position on Use of SI Units for Lab Tests

›
Previously, I wrote an article to discuss the SI unit versus US conventional unit . FDA actually issued its position statement about these t...
2 comments:
Sunday, November 16, 2014

VALOR Trial - A Successful and Failed Phase III Study with Adaptive Sample Size Re-stimation for Promising Zone

›
Motivated by searching for the innovative clinical trial methodologies to increase the clinical trial success and minimize the clinical tri...
2 comments:
Saturday, November 01, 2014

Standard of Care (SOC) as Control Group in Clinical Trials

›
For randomized, controlled clinical trials, the selection of the control group is one of the key issues in the study design. This is why IC...
1 comment: