A pivotal trial is a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by the United States Food and Drug Administration.Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials. References
Pivotal Study. Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
Pivotal Clinical Trial means a randomized, controlled clinical trial of a Product designed to demonstrate statistically significant clinical efficacy and safety in human patients (in conjunction with performance of a therapeutic procedure) pursuant to a clinical study agreed with the FDA, which trial the FDA accepts as a pivotal clinical trial necessary for Regulatory Approval of such Product.
Define pivotal. pivotal synonyms, pivotal pronunciation, pivotal translation, English dictionary definition of pivotal. adj. 1. Of, relating to, or serving as a pivot. 2. Being of vital or central importance; crucial: a decision that was pivotal to our success.
Recent Examples on the Web. Latham even played a pivotal role in Podesta's infamous email leal during the 2016 presidential campaign. — Chloe Foussianes, Town & Country, "Sara Latham, Meghan Markle and Prince Harry's New PR Manager, Worked for Hillary Clinton's Campaign," 14 Mar. 2019 The Murrays and the camp’s staff were pivotal in gaining access to these animals.
Pivotal definition, of, relating to, or serving as a pivot. See more.
pivotal study = zentrale/entscheidende Studie, daher dt. oft auch als Pivot-Studie bezeichnet) wird in der medizinischen Forschung eine klinische Studie bezeichnet, die zum Ziel hat, den signifikanten Wirksamkeitsnachweis eines therapeutischen Verfahrens (zum Beispiel eines Arzneimittels) zu erbringen.
Definition: Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
A pivotal bank function, therefore, is to intermediate between savers who demand complete liquidity and borrowers who require non-marketable loans. From Cambridge English Corpus Ontologies promise to play a pivotal role for different semantic-based and semantic-aware applications.
PHASES OF CLINICAL TRIALS Four phases of clinical trials and medicine development exist and are defined below. Each of these definitions is a functional one and the terms are not defined on a strict chronological basis. An investigational medicine is often evaluated in tow or more phases simultaneously in different clinical trials.
Pivotal definition: A pivotal role , point or figure in something is one that is very important and affects... | Meaning, pronunciation, translations and examples. ... Study guides for every stage of your learning journey. Whether you're in search of a crossword puzzle, a detailed guide to tying knots, or tips on writing the perfect college ...
Define Pivotal Study. means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and ...
MAESTRO-01 Trial The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is currently being conducted at more than 50 sites across Canada and Europe and will enroll approximately 550 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.
A medical device pivotal study is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use.
"Pivotal Study Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind." A Phase III study means:
2/21/2019 · It is time the international community faced the reality: we have an unmanageable, unfair, distortionary global tax regime. It is a tax system that is pivotal in creating the increasing inequality that marks most advanced countries today […].
FDA Regulatory Process . Michael J. Hoffmann, M.S. ... is one that does not meet the definition for an SR device ... be expected for a traditional feasibility or a pivotal study.
Upon successful completion of this pivotal study effort, we fully anticipate being able to introduce our LymPro Test to the public as the first blood diagnostic test in the market to help physicians in their efforts in expediting the diagnosis of this devastating disease," says Dr.
Noon at the ship is the pivotal point of the day's work at sea. Let us picture this pivotal scene of his life and of American history. It was one of the pivotal points of the war, and is of about medium height. But I could not discover that the massacre had any influence on the voters in the pivotal states.
5/5/2016 · Pivotal transforms how the world builds software. Pivotal combines the Silicon Valley state of mind, modern approach, and infrastructure with organizations’ core expertise and values. We enable ...
study [stud´e] a careful examination of a phenomenon; see also design. cohort study prospective study. cross-sectional study one employing a single point of data collection for each participant or system being studied. It is used for examining phenomena expected to remain static through the period of interest. It contrasts with a longitudinal s ...