Primary Analysis of Efficacy Clause Samples

The "Primary Analysis of Efficacy" clause defines how the main effectiveness of a treatment or intervention will be measured and evaluated in a clinical study. It typically specifies the primary endpoint, the statistical methods to be used, and the time points at which data will be analyzed. For example, it may state that the primary analysis will compare the proportion of patients achieving a specific outcome between treatment groups at a predetermined time. This clause ensures that all parties have a clear, agreed-upon framework for assessing whether the study's main objectives are met, thereby reducing ambiguity and potential disputes over the interpretation of results.
Primary Analysis of Efficacy. The ITT population, which includes all patients randomized within each cohort, will be used as the population for assessment of the primary efficacy endpoint. Mixed-model repeated measures (MMRM) analyses will be used to analyze the Phase 2 and Phase 3 primary and key secondary efficacy endpoints. For the Phase 2 portion of the study, eGFR values for all scheduled visits collected through the Week 12 visit will contribute to the primary analysis. For the Phase 3 portion of the study, eGFR values for all scheduled visits collected through the Week 48 visit will contribute to the primary analysis. The dependent variable will be change from baseline in eGFR. The model will include change from baseline in eGFR as the dependent variable, protocol-scheduled nominal time point as a fixed effect, patient as a random effect, and the baseline eGFR and log-transformed baseline ACR as continuous covariates. Within-patient correlations will be modeled using an unstructured covariance structure. Time ordering is a repeated measure within patients. It is assumed that errors for different patients are independent with an unstructured covariance structure. The estimation method for the model will be restricted maximum likelihood (REML). For analysis of the Phase 3 primary endpoint at Week 48, missing data in the ITT population will be imputed using Jump to Reference (J2R) multiple imputation (Ratitch, 2013) based on available data collected from patients discontinuing from study treatment but continuing in the study. Appropriate sensitivity analyses will be performed. The primary analyses of efficacy using an unstructured covariance structure is expected to have approximately the same power as the analysis with compound symmetry used for study planning. The analysis of the Phase 3 key secondary endpoint will be based on available Week 52 data from the subset of patients who complete the 48-week treatment course.
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Primary Analysis of Efficacy. ‌ The intent-to-treat (ITT) population, which includes all randomized patients who received at least one dose of study medication, will be used as the primary population for assessment of efficacy. Likelihood-based estimation with mixed-model repeated measures (MMRM) analysis will compare the treatment groups with respect to the primary endpoint. The dependent variable will be change from baseline in 6MWD. The model will include treatment, visit, and the treatment-by-visit interactions as fixed effects; stratification by number of background PAH therapies (0, 1, or 2); and visit as a repeated measure having an unstructured covariance structure. Covariates may be defined in the SAP as appropriate. Missing data will not be imputed for the primary analysis. To assess the assumption of missing at random (MAR), a tipping point approach for imputing missing data will be performed as a sensitivity analysis. Shift parameters will adjust the imputed values for observations in the treatment group, not the placebo group, until the p-value > 0.05. Multiple imputation will be used for missing data. Other sensitivity analyses may be performed as appropriate.
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Related to Primary Analysis of Efficacy

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Sampling and Analysis The sampling and analysis of the coal delivered hereunder shall be performed by Buyer upon delivery of the coal to Buyer’s facility, and the results thereof shall be accepted and used as defining the quality and characteristics of the coal delivered under this Agreement and as the Payment Analysis. All analyses shall be made in Buyer’s laboratory at Buyer’s expense in accordance with ASTM standards where applicable, or industry-accepted standards in other cases. Samples for analyses shall be taken in accordance with ASTM standards or other methods mutually acceptable to both parties. Seller shall transmit its “as loaded” quality analysis to Buyer as soon as possible. Seller’s “as-loaded” quality shall be the Payment Analysis only when Buyer’s sampler and/or scales are inoperable, or if Buyer fails to obtain a sample upon unloading. Seller represents that it is familiar with Buyer’s sampling and analysis practices, and that it finds them to be acceptable. Buyer shall notify Seller in writing of any significant changes in Buyer’s sampling and analysis practices. Any such changes in Buyer’s sampling and analysis practices shall, except for ASTM or industry-accepted changes in practices, provide for no less accuracy than the sampling and analysis practices existing at the tune of the execution of this Agreement, unless the Parties otherwise mutually agree. Each sample taken by Buyer shall be divided into four (4) parts and put into airtight containers, properly labeled and sealed. One (1) part shall be used for analysis by Buyer. One (1) part shall be used by Buyer as a check sample, if Buyer in its sole judgment determines it is necessary. One (1) part shall be retained by Buyer until thirty (30) days after the sample is taken (“Disposal Date”), and shall be delivered to Seller for analysis if Seller so requests before the Disposal Date. One (1) part (the “Referee Sample”) shall be retained by Buyer until the Disposal Date. Seller shall be given copies of all analyses made by Buyer by the fifth (5th) business day of the month following the month of unloading. In addition, Buyer shall send Seller weekly analyses of coal unloaded at Buyer’s facilities. Seller, on reasonable notice to Buyer, shall have the right to have a representative present to observe the sampling and analyses performed by Buyer. Unless Seller requests an analysis of the Referee Sample before the Disposal Date, Buyer’s analysis shall be used to determine the quality of the coal delivered hereunder and shall be the Payment Analysis. The Monthly Weighted Averages of specifications referenced in §6.1 shall be based on the individual Shipment analyses. If any dispute arises with regard to the analysis of any sample before the Disposal Date for such sample, the Referee Sample retained by Buyer shall be submitted for analysis to an independent commercial testing laboratory (“Independent Lab”) mutually chosen by Buyer and Seller. For each coal quality specification in question, if the analysis of the Independent Lab differs by more than the applicable ASTM reproducibility standards, the Independent Lab results will govern, and the prior analysis shall be disregarded. All testing of the Referee Sample by the Independent Lab shall be at requestor’s expense unless the Independent Lab results differ from the original Payment Analysis for any specification by more than the applicable ASTM reproducibility standards as to that specification. In such case, the cost of the analysis made by the Independent Lab shall be borne by the party who provided the original Payment Analysis.

  • Escrow Analysis If applicable, with respect to each Mortgage Loan, the Seller has within the last twelve months (unless such Mortgage was originated within such twelve month period) analyzed the required Escrow Payments for each Mortgage and adjusted the amount of such payments so that, assuming all required payments are timely made, any deficiency will be eliminated on or before the first anniversary of such analysis, or any overage will be refunded to the Mortgagor, in accordance with RESPA and any other applicable law;

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.