Challenges in Histological Endpoints for MASH Therapies: An Exercise in Statistical Modelling.

Background: Regulatory-accepted efficacy endpoints for nonalcoholic steatohepatitis (NASH; recently updated to metabolic-dysfunction associated steatohepatitis, MASH) clinical trials include fibrosis improvement with no worsening of NASH or NASH resolution with no worsening of fibrosis determined by liver biopsy using the NASH Clinical Research Network criteria. These endpoints involve the scoring of four liver histology parameters, all of which are associated with significant inter-/intra-reader variability. Since few trials have shown positive results with these endpoints, we evaluated the effects of imprecision in histologic scoring on trial results from a statistical perspective.

Review article: Recommendations for detection, assessment and management of suspected drug-induced liver injury during clinical trials in oncology patients.

Background: Drug-induced liver injury (DILI) is a major concern for oncology drugs in clinical practice and under development. Monitoring cancer patients for hepatotoxicity is challenging as these patients may have abnormal liver tests pre-treatment or on-study for many reasons including liver injury due to past oncology treatments, hepatic metastases, medical co-morbidities such as heart failure, and concomitant medications. At present, there are no regulatory guidelines or position papers that systematically address best practices pertaining to DILI detection, assessment and management in oncology patients.

Biases in Ecoacoustics Analysis: A Protocol to Equalize Audio Recorders.

Eco-acoustic indices allow us to rapidly evaluate habitats and ecosystems and derive information about anthropophonic impacts. However, it is proven that indices' values and trends are not comparable between studies. These incongruences may be caused by the availability on the market of recorders with different characteristics and costs.

Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy.

Hepatitis B virus reactivation (HBVr) during and after immunosuppressive/immunomodulatory (IS/IM) therapy is associated with significant morbidity and mortality, including hepatic decompensation and acute liver failure. The risk of HBVr with IS/IM has been heterogeneous and often unpredictable. As a result, patients with active or previous HBV infection are often excluded from clinical drug trials of such agents.