ISPOR Europe 2022 -- Immortal time arises when the determination of a patient's treatment status involves a waiting period. A bias is introduced when this period is unaccounted for in the assessment of treatment effectiveness and/or safety.

ISPOR Europe 2022 -- Advanced therapy medicinal products (ATMPs), such as cell and gene therapies, are often associated with single administration and curative potential in many chronic, life-limiting and life-threatening diseases.

Systemic lupus erythematosus (SLE) clinical trials are complex, and, to date, only three compounds have been approved for this condition. There remains some controversy around which outcome measures and endpoints are best for SLE trial design.

SETAC North America 2022 -- Fish bioconcentration or biomagnification studies are carried out to determine whether substances have the potential to bioaccumulate and have potential to biomagnify throughout different trophic levels.

SETAC North America 2022 -- Two significant OECD guidelines for endocrine disruption in non-target organisms are the OECD 231 and OECD 241, both using the test species of Xenopus laevis. Despite these being a model species, they are not a species routinely used in Contract Research Organisations (CROs), as routine testing is unusual in frog species.

SETAC North America 2022 -- With the increasing popularity of fish-based diets, a large proportion of fish we eat comes from fish farms. The diet used in these farms often comprises a substantial portion of plant commodities, leading to a potential risk of exposure to pesticide residues.

ACT 2022 -- An environmental risk assessment (ERA) is mandatory for marketing authorisation of pharmaceuticals in the European Union (EU), following the European Medicines Agency (EMA) guidelines. In most cases, a costly program of physico-chemical, environmental fate and effects testing is required.

ACT 2022 -- Rodent motor disturbances observed on preclinical toxicology and carcinogenicity studies may lead to challenging assessments when determining if observations are drug-related or background.

Only around 5%-13% of people who take part in cancer trials are Black or African American, Asian, or Hispanic, compared with 75% of white people. Labcorp is committed to addressing healthcare disparities, improving diversity in clinical trials and making clinical trials accessible for all.