False Negative ECG Device Results May Increase the Risk of Adverse Events in Clinical Oncology Trials.

Background: Sites participating in clinical trials may not have the expertise and infrastructure to accurately measure cardiac intervals on 12-lead ECGs and rely heavily on the automated ECG device generated results for clinical decision-making.

Methods: Using a dataset of over 260,000 ECGs collected in clinical oncology studies, we investigated the mean difference and the rate of false negative results between the digital ECG machine QTc and QRS measurements compared to those obtained by a centralized ECG core lab.

Results: The mean differences between the core lab and the automated algorithm QTcF and QRS measurements were + 1.

Poly-l-glutamic acid derivatives as multifunctional vectors for gene delivery. Part B. Biological evaluation.

Cationic polymers, such as poly-l-lysine (pLL) and polyethyleneimine (pEI), are receiving growing attention as vectors for gene therapy. They form polyelectrolyte complexes with DNA, resulting in a reduced size of the DNA and an enhanced stability toward nucleases. The major disadvantages of using both polymers for in vivo purposes are their cytotoxicity and, in the case of pEI, the fact that it's not biodegradable.

Poly-l-glutamic acid derivatives as multifunctional vectors for gene delivery. Part A. Synthesis and physicochemical evaluation.

This paper describes the synthesis and evaluation of a series of multifunctional poly-l-glutamic acid derivatives that can be used as vectors for gene delivery. They readily form polyelectrolyte complexes with DNA, resulting in a reduced surface charge and size of the DNA. The formation of a polymer-DNA complex and the stability toward serum albumin was analyzed by ethidium bromide fluorescence measurements and agarose gel retardation studies.