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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Adaptive Trial means a human clinical trial that is a Phase 2 Clinical Trial that does not meet the criteria for a Phase 3 Clinical Trial at the time such human clinical trial is Initiated and includes a prospectively planned opportunity for such human clinical trial to be modified based on interim analyses to change to a Phase 3 Clinical Trial following an analysis of interim data from subjects in such human clinical trial.
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Examples of Adaptive Trial in a sentence

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

  • In: Practical Considerations for Adaptive Trial Design and Implementation.

  • Broader Application of Bayesian Statistics and Adaptive Trial Designs BackgroundThe traditional approach to clinical trials for drugs has focused on a design planned in advance that includes specific treatments and doses and durations, specified decision rules for patient/subject assignment to treatment groups, and prespecified statistical analysis to test a prespecified qualitative and quantitative hypothesis.

  • 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.

  • Therefore, An outlay of` 1974.62 lakh is proposed for organizing demonstration of these crops in 2014-15. Adaptive Trial Centers (ATCs)- An outlay of ` 75.00 lakh is proposed for adaptive research component for the Annual Plan 2014-15.

  • 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.

  • 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.

  • Hence, to popularize organic farming practices among the cultivators, it is proposed to lay out demonstration on the cultivator's field under the supervision of scientists of State Agriculture Universities and offices of Adaptive Trial Centers, for which assistance will be 50 per cent of the cost of inputs i.e. organic matter (compost and vermi compost) cost of seed, bio-fertilizers, bio agents, neem based pesticides etc or maximum` 1000/- whichever is less for 0.4 ha per season.

  • Under this programme specific need based trials would be laid out both at Adaptive Trial Centers and on farmer’s field which would include various aspects on varietal adaptability/integrated nutrient management/organic farming/integrated pest management/ improved seed production etc.

  • It should be noted, however, that the number of scientific publications on the barriers to SMEs development in Poland has declined recently.The analysis of research and opinions related to the business environment brings interesting results.

Related to Adaptive Trial

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

  • JRC has the meaning set forth in Section 2.1.1.

  • JSC has the meaning set forth in Section 3.1.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Development Program means the implementation of the development plan.

  • 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 a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Collaborating physician means the physician who,

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

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

  • 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.