protocol amendment

protocol amendment

In clinical trials, a written description of one or more changes to, or formal clarifications of, the study protocol.
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DelMar Pharmaceuticals announced the University of Texas MD Anderson Cancer Center's, or MDACC, Institutional Review Board, or IRB, has approved a trial protocol amendment to expand DelMar's ongoing Phase 2 clinical trial of VAL-083 in patients with MGMT-unmethylated glioblastoma, or GBM.
For example, the direct cost to implement a single protocol amendment averages approximately $500,000 in unplanned expenses and adds 61 days to project timelines.
The protocol amendment incorporating the two new cohorts was designed based on input from the FDA.
The update made on the website www.ClinicalTrials.gov regarding this trial, is a technical update related to a protocol amendment that has been implemented in 2015.
However, because of "an outpouring of inquiry and support from Canadian patients," a protocol amendment was filed with the FDA, which okayed it.
The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
Finally, during its Presidency, Athens hopes to be able to conclude the ratification process for the Kyoto Protocol amendment (Kyoto II).
Data recorded for each protocol submission included whether this was a first application or a protocol amendment, the sponsor of the trial, the principal investigator (PI), phase of trial (I, II, III or IV), and the year and month of submission.
There was protocol amendment to include younger patients (50 to 54years of age) or those with less recent strokes (within 90 to 120 days before randomization) if they also had at least two additional vascular risk factors.
The draft protocol amendment is available at www.europolitics.info > Search = 275139
Because of a protocol amendment during the study the end point was changed to cardiovascular hospitalization or all-cause mortality, which turned out not to be significantly different between the groups.
In addition, IMV submitted a protocol amendment for a predictive enrichment approach to the phase 2 DECIDE trial, and further discussed those details with the FDA during the Type B meeting.