The EU Directive requires retention for at least 5 years after trial end (for nonregulatory submission trials) and for a trial leading to a product licensing submission, at least 2 years after the last approval of a marketing application in the EU.
At the time of manuscript submission the trial is open to recruitment.
This can be explained by the delay between the first submission of trial results by responsible parties and their public posting at ClinicalTrials.gov.gov
The precision of the assay using an automated chemiluminometer (LB 953, Berthold) yielded a CV (co-efficient of variation, standard deviation divided by mean times 100) of less than 10% at EAs above 0.4 (US FDA submission, MEDIC trial).
Unlike Finland, most (58%) of the submissions concerned trials, i.e., research with an experimental design.
FHSW was involved in preclinical studies, the design, implementation, submission of the trial, in the drafting of the protocol, the manuscript and is the PI of the running trial.
At the time of this article's submission, the clinical trials have followed the proposed trial timeline and patients have begun to benefit from the treatment of avitinib.
Each submission is a trial.
LBirrell, ZT, NN and MT are responsible for ethics and clinical trial submission, recruitment of schools, and data collection.
EB, NN and MT are responsible for ethics and clinical trial submission, recruitment of schools, and data collection.
