Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale
platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug …

The first regulatory approval for a drug developed specifically for cystic fibrosis (CF)
occurred in 1993, and since then, several other drugs have been approved. Median …

Objective Whilst microdiscectomy is an excellent reliever of pain for recalcitrant lumbar disc
herniation (LDH), it has a high failure rate over time due to the ensuing reduction in …

Even though proof-of-concept (POC) has become a common practice of organizations in
decision-making, and internal and external coordination processes, the literature on …

Biopharmaceutical industry portfolios have diversified from ones centred on protein
therapeutics to inclusion of a myriad of novel modalities, such as cell and gene therapies …

The key points of this chapter are:• Clinical trials are a type of prospective experimental
study in which human volunteers receive specific interventions according to the research …

Phase I trials are the first pharmacological studies in humans, without therapeutic objectives
and often include healthy subjects administered either an active investigational drug or a …

O presente relatório surge no contexto do estágio curricular em Coordenação de Ensaios
Clínicos realizado na Unidade de Investigação Clínica do Instituto Português de Oncologia …

A novel group-sequential phase II design for clinical trials with binary endpoints based on
Bayesian evidence values Page 1 A novel group-sequential phase II design for clinical trials …

Este relatório foi elaborado no âmbito do estágio curricular em Coordenação de Ensaios
Clínicos na Unidade de Investigação Clínica do Instituto Português de Oncologia do Porto …