Computational and Numerical Investigation of the Batch Markovian Arrival Process Subject to Renewal Generated Geometric Catastrophes.

In this paper, we consider a stochastic model in which the population grows according to the batch Markovian arrival process and is subjected to renewal generated geometric catastrophes. Our analytical work starts from the vector generating function (VGF) of the population size at post-catastrophe epoch. We develop a methodology for extracting the population size distribution at post-catastrophe epoch from the VGF, which is based on the inversion of VGF using the roots method.

Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations.

Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants' cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects.

Phase 0 clinical trials in oncology new drug development.

Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer.