Bayesian hierarchical model for safety signal detection in multiple clinical trials.

Clinical safety signal detection is of great importance in establishing the safety profile of new drugs and biologics during drug development. Bayesian hierarchical meta-analysis has proven to be a very effective method of identifying potential safety signals by considering the hierarchical structure of clinical safety data from multiple randomized clinical trials conducted under an Investigational New Drug (IND) application or Biological License Application (BLA). This type of model can integrate information across studies, for instance by grouping related adverse events using the MedDRA system-organ-class (SOC) and preferred terms (PT).

Varicella Virus Vaccine Live: A 22-Year Review of Postmarketing Safety Data.

Background: Varicella, a contagious infectious disease caused by varicella zoster virus (VZV), can result in hospitalization and, occasionally, death. Varicella virus vaccine live (VVVL [VARIVAX]) was introduced in the United States in 1995.

Methods: This comprehensive review of the VVVL safety profile is based on 22 years of postmarketing adverse event (AE) data received through spontaneous and noninterventional study reports submitted by health care providers and on a review of the published literature (cumulatively from March 17, 1995, through March 16, 2017, during which period >212 million doses were distributed globally).

An alternative algorithm for dosing transdermal fentanyl for cancer-related pain.

Many cancer patients are undermedicated and inappropriately managed for pain, leading to a diminished quality of life. Patients with moderate to severe pain often require opioid analgesics. Recently published guidelines emphasize individualization of opioid treatment to provide the drug and route of administration that meet the needs of the particular patient.