In September 2018, the FDA issued a new draft guidance for industry — Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material.
Electronic patient-reported outcomes (ePRO) are essentially a validated set of questionnaires that are given to patients to assess subjective experiences. With many trials now incorporating ePRO, this article examines three critical considerations for sponsors when implementing ePRO solutions into their trials.
For the biopharma industries specifically, artificial intelligence (AI) represents an opportunity to avert the R&D productivity crisis with paradigm-shifting applications such as in-silico drug design, prediction of trial risks, and big data analytics. This article discusses how pharma needs to address the opacity of AI to ensure trust and credibility with all stakeholders.
Learn how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies that may lack their own internal oversight resources.