Trial characteristic |
Definition |
Types of file |
It contains public assessment reports, scientific
discussions, and product information, all of which were reviewed and
evaluated manually to determine whether they incorporated adaptive
design for relative confirmatory or exploratory trials. |
Year of authorization |
It derived from the date when medical products
were granted with the first marketing authorization. |
Orphan designation |
It determines whether the medince is designated as
an orphan drug that referred to treatments for rare
diseases. |
Pivotal status |
It determines whether an adaptive design is scheduled
into a confirmatory trial. |
Accelerated assessment status |
It defines whether the assessment is a
rapid assessment of medicines in the centralised procedure with shorter
period of assessment, which usually takes 150 evaluation days, rather
than 210 days. |
AM status |
It defines whether the medicine is being monitored closely
by regulatory authorities and surveilled more intensively than
others. |
CMA |
Medicines granted CMA usually correspond to the interest of public
health but with less comprehensive clinical data than generally
required |
PASS/PAES |
It is a study that is carried out after a medicine has been
authorized to obtain further information relevant to the safety/efficacy
of it. |
NAS status |
It defines whether the medicine is a chemical substance not
previously authorized as medicinal product in European
Union. |
SOC |
It is the highest level of the Medical Dictionary for Regulatory
Activities (MedDRA) 1 hierarchy, which was distinguished by the
anatomical or physiological system, etiology (disease origin), or
purpose. |
Antitumor status |
It depends on whether indications were for cancer
diagnosis or treatment. |
Study progression |
It is derived from the progression of clinical
trials at the time when products were approved, including completed and
ongoing trials. |