Adaptive Trial definition

Adaptive Trial means a Clinical Trial that is designed to allow for a prospectively planned modification from a Phase II Clinical Trial to a Phase III Clinical Trial based on accumulating data from subjects in such Clinical Trial (as permitted by the FDA).
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Examples of Adaptive Trial in a sentence

  • Structural failures can occur with any type of conduit, but they are most often associated with flexible pipes (e.g., CMPs and plastic pipes), that derive most of their load carrying capability from the surrounding backfill.

  • Pioneering Statistical Approaches to Accelerate Drug Development through Adaptive Trial Designs.

  • Davis*, University of North Carolina, Chapel Hill4:15 Introduction to the Sequential Enriched DesignYeh-Fong Chen*, U.S. Food and Drug AdministrationRoy Tamura, University of South Florida4:45 Integrity and Efficiency of Enrichment and Adaptive Trial Designand Analysis Options to Enable Accurate and Precise Signal DetectionMarc L.

  • Members of BERD have established local special interest groups in Adaptive Trial Designs, Environmental Epidemiology, and Causal Inference.

  • Broader Application of Bayesian Statistics and Adaptive Trial Designs: This section would require FDA to hold a public meeting and issue guidance documents that would assist sponsors in incorporating adaptive designs and Bayesian statistical modeling into their clinical protocols and new drug applications.

  • The report said that the experiment would be conducted in the format of Adaptive Trial Design (ATD), in the first stage, 150 participants would be recruited.

  • Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

  • The Adaptive Trial Farm will be established in the existing BBU Marhagayu at Lembang as a technical center of vegetable cultivation in the Project.

  • Adaptive Trial Designs FDA is also actively involved in developing adaptive trial designs, including designs with Bayesian adaptations based on interim assessments of biomarkers.

  • Broader Application of Bayesian Statistics and Adaptive Trial De- signs.

Related to Adaptive Trial

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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 to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • JMC has the meaning set forth in Section 3.2(a).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • JDC has the meaning set forth in Section 3.2.

  • JRC has the meaning set forth in Section 2.2.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • JSC has the meaning set forth in Section 3.1.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Development Program means the implementation of the development plan.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • JCC has the meaning set forth in Section 3.1.

  • Positive Test Result means a finding of the presence of drugs, alcohol, or their metabolites in the sample tested in levels at or above the threshold detection levels contained in the standards of one of the programs listed in Minn. Stat. § 181.953, Subd. 1.

  • Clinical Trial means any human clinical trial of a Product.

  • Collaborating physician means the physician who,

  • Development Plan has the meaning set forth in Section 3.2.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Licensed Compound means [***].

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.