Trial Watch: Phase II and Phase III attrition rates 2011–2012

  title={Trial Watch: Phase II and Phase III attrition rates 2011–2012},
  author={John Edmund Arrowsmith and Philip J Miller},
  journal={Nature Reviews Drug Discovery},

Harnessing Human Microphysiology Systems as Key Experimental Models for Quantitative Systems Pharmacology.

Quantitative systems pharmacology is a complementary approach to traditional, target-centric pharmacology and drug discovery and is based on an iterative application of computational and systems biology methods with multiscale experimental methods, both of which include models of ADME-Tox and disease.

CNS Target Identification and Validation: Avoiding the Valley of Death or Naive Optimism?

Previous methods for identifying and validating novel targets for CNS drug discovery are outlined, and potential new strategies that may improve the probability of success of developing novel treatments for CNS disorders are discussed.

Workshop on challenges, insights, and future directions for mouse and humanized models in cancer immunology and immunotherapy: a report from the associated programs of the 2016 annual meeting for the Society for Immunotherapy of cancer

The workshop focused on key issues in optimizing models for cancer immunotherapy research, with discussions on the strengths and weaknesses of current models, approaches to improve the predictive value of mouse models, and advances in cancer modeling that are anticipated in the near future.

Novel methods for early phase clinical trials

Bayesian sample size calculations for single-arm and randomised phase II trials with time-to-event endpoints are considered and sample sizes obtained are consistent with those currently used in practice while better accounting for available information and uncertainty in parameter estimates of the time- to-event distribution.

Flexible Drug Approval Policies

Results indicate that a more lenient policy is warranted for drugs targeting breast cancer or hypertension, and a more stringent policy is recommended for HIV, relative to the FDA’s existing policy, and an optimal policy is solved to maximize net life-years gained following FDA approval.

A comparison of stochastic programming methods for portfolio level decision-making

This work compares two existing approaches that use stochastic programming techniques and formulate the problem as a mixed integer linear programme (MILP) for the management of a pharmaceutical portfolio.

Drug Metabolism in Early Stage Drug Discovery and Drug Development

A novel in vitro method to detect the liver enzymes derived active metabolites against Mycobacterial tuberculosis was developed and it was found that the inhibition of 7-hydroxylation of (S)-warfarin occurs through mechanism-based inactivation.

Transparency in Non-Technical Project Summaries to Promote the Three Rs in Respiratory Disease Research.

This study outlines a novel systematic analysis approach that enables the assessment of NTS transparency based on the accuracy of reporting of certain Three Rs-specific information, and concludes that data in NTS can be successfully used as a basis for systematic analysis.

A guide to open science practices for animal research.

Translational biomedical research relies on animal experiments and provides the underlying proof of practice for clinical trials, which places an increased duty of care on translational researchers