Study designs Clause Samples

Study designs. After evaluators choose a framework, they are ready to select an appropriate study design. There are three kinds of designs: the simple before-after evaluation, the controlled before-after evaluation, and the randomized controlled trial. The simple before-after design is the most commonly used non-experimental design for information system evaluation. In this design, the evaluation team will compare the current system performance with its previous performance. Of course, an appropriate amount of time should be left to allow the new system to be fully functional. Moreover, measuring indicators repeatedly at different time points may also help to show the reliability of those effects (Shojania KG et al. 2005).
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Study designs. A double-blind, stratified and randomised evaluation of AZD5363 when combined with weekly paclitaxel vs. weekly paclitaxel plus placebo. Approximately 100 female patients, with ER+ve advanced or metastatic breast cancer will be enrolled in this phase, of which approximately 50 must have a tumour detectable as carrying a PIK3CA mutation. The dose and schedule of AZD5363 will be selected as an outcome from the safety run-in, Part A. All enrolled patients will be stratified to either the PIK3CA mutation ‘detected’ or ‘not detected’ group by the outcome of two tests (tissue and blood (ctDNA)). If a patient is detected as having the PIK3CA mutation in both or either of the two tests, they will be assigned to the mutation detected strata. If the mutation is not detected in both of the two tests, (or should one test be not detected and the other is either unknown or not completed for any reason) the patient will be assigned to the not detected strata. This will be referred to as the protocol definition of PIK3CA mutational status. Patients within each stratum will be randomised to 28-day cycles comprising either of: • Paclitaxel 90 mg/m2 IV once weekly plus AZD5363 capsules taken orally, twice daily. • Paclitaxel 90 mg/m2 IV once weekly plus AZD5363-matching placebo capsules taken orally, twice daily. The overall study plan for PART B is shown in Figure 1.
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Related to Study designs

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • ROADWAY DESIGN MISCELLANEOUS (ROADWAY)

  • Program Design The County Human Resources Department will operate a Catastrophic Leave Bank which is designed to assist any County employee who has exhausted all paid accruals due to a serious or catastrophic illness, injury, or condition of the employee or family member. The program establishes and maintains a Countywide bank wherein any employee who wishes to contribute may authorize that a portion of his/her accrued vacation, compensatory time, holiday compensatory time or floating holiday be deducted from those account(s) and credited to the Catastrophic Leave Bank. Employees may donate hours either to a specific eligible employee or to the bank. Upon approval, credits from the Catastrophic Leave Bank may be transferred to a requesting employee's sick leave account so that employee may remain in paid status for a longer period of time, thus partially ameliorating the financial impact of the illness, injury, or condition. Catastrophic illness or injury is defined as a critical medical condition, a long-term major physical impairment or disability which manifests itself during employment.

  • Preliminary Design § 4.3.1 Upon the Owner’s issuance of a written consent to proceed under Section 4.2.3, the Design-Builder shall prepare and submit a Preliminary Design to the Owner. The Preliminary Design shall include a report identifying any deviations from the Owner’s Criteria, and shall include the following: .1 Confirmation of the allocations of program functions; .2 Site plan; .3 Building plans, sections and elevations;

  • Schematic Design See Section 2, Part 1, Article 2.1.4, Paragraph 2.1.4.2.