Abr - 2016

Investigator Initiated Clinical Trial (IICT)

Investigator Initiated Clinical Trial (IICT): are clinical trials that are instigated by academic researchers and are aimed to acquiring scientific knowledge and evidence to improve patient care.
IICT is a patient-oriented clinical research type with achievable innovations at diagnostic and therapeutic levels that try to answer important questions in clinical practice that are not attractive for companies. It encompasses studies on orphan diseases and proof of concept, permits the comparison of diagnostic or therapeutic interventions and stimulate the development of surgical therapies or novel indications for registered drugs. They provide robust evidence to support policy makers in the sustainability of the National Health Service.
The sponsor/sponsor-investigator is a university, a hospital, a public scientific organisation, a non-profit institution, a patient organisation or a researcher.
The ownership of the data should belong to the sponsor/sponsor-investigator. No agreement in place that allows using the data for regulatory or marketing purposes.
Multicenter Trial (ICH-GCP(E6)): A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.