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.

DelMar receives approval from MDACC for protocol expansion of VAL-083 trial

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.

Clinical Trial Feasibility: How to reduce late-stage trial risk with feasibility analysis

The protocol amendment incorporating the two new cohorts was designed based on input from the FDA.

Spectrum Pharmaceuticals Expands Poziotinib Clinical Trial into First-Line Therapy and Doses First Patient

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.

NANOBIOTIX' Management Statement on Recent Share Price Variation

However, because of "an outpouring of inquiry and support from Canadian patients," a protocol amendment was filed with the FDA, which okayed it.

Canadian Patients Allowed To Join Phase 3 Trial Of ALS Treatment

Finally, during its Presidency, Athens hopes to be able to conclude the ratification process for the Kyoto Protocol amendment (Kyoto II).

CLIMATE CHANGE : RACE AGAINST TIME FOR ATHENS

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.

Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa

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.

What is better antiplatelet agent to prevent recurrent stroke?

The draft protocol amendment is available at www.europolitics.info > Search = 275139

PARLIAMENT : LISBON TREATY FORMALLY AND DISCREETLY REVISED

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.

Panel backs Carvedilol's mortality benefit after acute MI. (Left Ventricular Dysfunction)

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.