Sample Size Considerations Clause Samples

The 'Sample Size Considerations' clause defines the requirements and parameters for determining the number of subjects or units to be included in a study or trial. It typically outlines the statistical rationale for the chosen sample size, such as power calculations or expected effect sizes, and may specify minimum or maximum enrollment numbers. This clause ensures that the study is adequately powered to detect meaningful results, thereby enhancing the reliability of findings and preventing wasted resources on under- or over-enrolled studies.
Sample Size Considerations. Sample size calculations based on various incidence rates in the control arm, relative vaccine efficacies for those in the MVA-NP+M1 arm, and alpha levels (two-sided) are provided in Table 7-1. All calculations assume 80% power and given this is a proof of concept study an alpha of 0.1 is chosen for powering analyses. Based on the projected range of incidence rates in the control arm, a total sample size of approximately 5000 to 6000 participants over two influenza seasons is expected to provide approximately 80% power to detect a meaningful vaccine efficacy (approximately 35%) in the MVA-NP+M1 arm. After the first influenza season, which will enrol approximately 2,200 participants, a sample size recalculation may be performed on the basis of the observed relative vaccine efficacy of MVI-NP+M1 during the first influenza season. This will be described in more detail in the SAP.
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Sample Size Considerations. Total of 280 patients in 2 groups of equal size (140 per group) Primary comparison: Obeticholic acid group vs. Placebo group Primary outcome measure: Histological improvement in NAFLD (defined above) Error protection: Type I= 0.05 and Type II= 0.10 (90% power) Missing data: 10% will not have 72 week biopsies and will be considered not improved Minimum clinically important difference: 50% higher relative rate of improvement in the obeticholic acid group vs. the placebo group Assumed response rates: 1. Expected percent with improved NAFLD (defined above) in the placebo group: 39% (based on PIVENS data and 2 to 1 split for patients on vs. not on vitamin Eat start of trial) 2. Expected percent with improved NAFLD in the obeticholic acid group: 58%
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Sample Size Considerations. Sample size is determined by the number of patients who participated in the previous phase III Study (RP103-03) and any additional patients, who did not complete the RP103-03 study, who enroll after all patients that participated in RP103-03 have completed and data have been analyzed.
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Sample Size Considerations. In the Phase 1b dose escalation, at least 9 participants are expected to be enrolled. The sample size was determined empirically and is consistent with those used in this type of initial human clinical study. A total of at least 108 additional participants are expected to be treated in the Phase 2a (dose expansion) with OPT-302 at the MTD or highest dose tested from the Phase 1b, in combination with aflibercept (72 participants) or with aflibercept alone (36 participants). Increasing numbers of participants will be exposed in the various phases of the trial: • In the Phase 1b dose escalation, if 3 participants will be treated with OPT-302 per cohort (without dose limiting toxicity), a total of at least 9 participants will be treated in this phase of the trial. • In the Phase 2a dose expansion, 72 additional participants will be enrolled at the MTD or the highest dose level of OPT-302 (determined from the Phase 1b). In case one or more of these 72 participants are not evaluable, randomization will continue and more patients will receive the same dose. • A total of up to at least 81 participants receiving OPT-302 is anticipated to be enrolled in the trial (9 in Phase 1b and 72 in Phase 2a). The table below shows the true proportion of patients with an AE that can be ruled out at various confidence levels, assuming no such event is observed in the trial. In the Phase 2a dose expansion, subjects will be allocated in a 2:1 ratio to one of two treatment groups, aflibercept with OPT-302 or aflibercept with sham, with minimization for two baseline characteristics: BCVA (≤ 55 vs. > 55 letters) and CST (≤ 450 vs. > 450 µm). The primary outcome of the Phase 2a is the proportion of evaluable patients with a response of ≥ 5 letter gain in BCVA from baseline to week 12 according to ETDRS criteria in the combination aflibercept + OPT-302 group. The design of the trial is non-comparative in so far as the sample size is calculated for the aflibercept + OPT-302 arm only. A one-stage design is used for the primary outcome (▇▇▇▇▇▇▇ 2001) of the aflibercept + OPT-302 arm. A formal rule allows for the assessment of the observed response rate as compared with pre-specified “low” and high response rates. Specifically, the hypotheses of interest are H0: r ≤ r0 (“low” response rate) against HA: r ≥ rA (“high” response rate). The following assumptions were made for sample size calculations: o the pre-specified “low” and “high” response rates are r0 = 0.28 and rA = 0.45 o the type I ...
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Sample Size Considerations. This study uses an open-label, 2-cohort design to test for an improvement in ▇▇▇. Up to approximately 130 subjects with r/r MCL will be enrolled and treated with anti‑CD19 CAR T cells, including 10 axicabtagene ciloleucel subjects and up to approximately 80 KTE-X19 subjects in Cohort 1 and up to 40 KTE-X19 subjects in Cohort 2. The primary analysis will be conducted after 60 Cohort 1 KTE-X19 subjects have been enrolled and treated and have had the opportunity to be evaluated for response 6 months after the Week 4 disease assessment. For the test of efficacy, 60 KTE-X19 subjects in Cohort 1 will provide at least 96% power to distinguish between an active therapy with a 50% true response rate from a therapy with a response rate of 25% or less (undesirable response rate, for purposes of futility assessment) with a 1-sided alpha level of 0.025. No hypothesis will be tested in Cohort 1 axicabtagene ciloleucel subjects or Cohort 2 subjects. Exploratory analyses will be conducted on the data collected from these subjects. In Cohort 1, 4 interim analyses will be performed: • Cohort 1 interim analysis 1 will be conducted after 10 subjects in Cohort 1 have been enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be followed for 30 days. This interim analysis will be for safety only. • Cohort 1 interim analysis 2 will be conducted after 20 subjects in Cohort 1 have been enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be evaluated for response 3 months after treatment with anti‑CD19 CAR T cells. In this interim analysis, the DSMB will review data for both safety and efficacy (futility only). • Cohort 1 interim analysis 3 will occur after 38 subjects in Cohort 1 have been treated with anti‑CD19 CAR T cells and have had the opportunity to be assessed for response 6 months after the treatment with anti‑CD19 CAR T cells. This interim analysis will be performed for a Kite internal review of the accumulating data of safety and efficacy. • Cohort 1 interim analysis 4 will occur after 44 subjects in Cohort 1 have been treated with anti‑CD19 CAR T cells and have had the opportunity to be followed for at least 30 days. In this interim analysis, the DSMB will review data for safety only, with focus on the 6 KTE-X19 subjects treated most recently in this cohort. In Cohort 2, one interim analysis will be performed: • Cohort 2 interim analysis will be conducted after 10 subjects in Cohort 2 have been enrolled and treated w...
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Sample Size Considerations. The design of the particular retrospective study has an observational character focusing on a specific disease i.e. breast cancer. The aim is to analyse the relationships between biological, psychological and social factors and their influence on resilience among breast cancer patients. Given the number and the heterogeneity of the clinical centres involved in the BOUNCE project, it is not possible to predict a priori the optimal sample size. The goal is to collect as many data sets as possible, in order to obtain the most representative sample.
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Sample Size Considerations. The primary endpoint is the percentage of patients progressing at 6 months. Based on a contemporary control of no maintenance after best response to prior chemotherapy8, the control arm with pembrolizumab alone is expected to have only 8% of patients with no progression at 6 months. To be of clinical interest, at least 58% of patients must be progression-free at 6 months on the pembrolizumab plus paricalcitol arm. A sample size of 12 patients per arm will provide 90% statistical power to detect this difference assuming a one-sided alpha level of 0.05. A one-sided test was selected as we are only interested in the combination if it decreases the percentage of patients progressing at 6 months. This sample size estimate was obtained using binomial enumeration of all possible outcomes to compare two independent binomial proportions (▇▇▇▇▇▇▇’▇ ▇▇▇-squared test) using PASS 15.18 A statistical concern is that the ▇▇▇▇▇▇▇ ▇▇▇-squared test does not guarantee the alpha level. We confirmed that we have adequate statistical power using the Miettinen & Nurminen 19 exact likelihood score method (89% power) using Pass 15.
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Sample Size Considerations. The anticipated enrollment in this study is approximately 100 subjects. The primary efficacy endpoint and all analyses based on the response will be based on a mITT population consisting of all subjects who receive any dose of KTE-X19 in Phase 2. This study uses a single-arm design to test for an improvement in overall complete remission rate. For the test of efficacy this study has approximately 93% power to distinguish between an active therapy with a 65% true overall complete remission rate from a therapy with an overall complete remission rate of 40% or less with a 1-sided alpha level of 0.025. A step-down test of the secondary endpoint MRD-negative Rate will be performed against a MRD-negative rate of 30% if the testing of the overall complete remission rate is significant. In Phase 1, the SRT will review safety data after 3 subjects in the DLT evaluable set (see Section 10.5) have had the opportunity to be followed for 28 days after the KTE-X19 infusion. If the conditioning regimen and KTE-X19 dose evaluated in Phase 1 is determined to be safe based on the incidence of DLT, up to approximately 30 additional subjects may be enrolled to further evaluate safety prior to commencing Phase 2. During Phase 2, one interim and one primary analyses will be performed. The interim analysis is for safety only and will occur after 20 subjects have been treated with KTE-X19 and have had the opportunity to be followed for 30 days after the KTE-X19 infusion. The primary analysis will occur when the overall study enrollment is complete and all subject in the mITT set have had the opportunity to complete the month 6 disease assessment. 65% Approximately 100 subjects may be enrolled into the entire study. At the time of the primary analysis, in the event that either less than or more than 50 subjects are eligible for the mITT set, all mITT eligible subjects will be included in the analysis.
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Related to Sample Size Considerations

  • Special Considerations The Provider position may be abolished at any time by the Collin County Commissioners Court.

  • General Considerations a. All reports, drawings, designs, specifications, notebooks, computations, details, and calculation documents prepared by Vendor and presented to the Board pursuant to this Agreement are and remain the property of the Board as instruments of service. b. All analyses, data, documents, models, modeling, reports and tests performed or utilized by Vendor shall be made available to the Board upon request and shall be considered public records. c. Vendor is required to: (i) keep and maintain public records required by Board; (ii) upon request from Board’ s custodian of public records, provide Board with a copy of the requested records or allow the records to be inspected or copied within a reasonable time at a reasonable or as otherwise provided by law; (iii) ensure that public records that are exempt or, confidential and exempt, from public records disclosure requirements are not disclosed except as authorized by law for the duration of this Agreement and following completion of this Agreement if Vendor does not transfer the records to Board; (iv) upon completion of this Agreement, transfer, at no cost, to Board all public records in possession of Vendor or keep and maintain public records required by Board. d. If Vendor transfers all public records to Board upon completion of this Agreement, Vendor shall destroy any duplicate public records that are exempt or, confidential and exempt, from public records disclosure requirements. If Vendor keeps and maintains public records upon completion of this Agreement, Vendor shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to Board, upon request from Board’s custodian of public records, in a format that is compatible with the information technology systems of Board. e. Vendor shall keep all books, records, files, drawings, plans and other documentation, including all electronically stored items, which concern or relate to the services required hereunder (the “Records”), for a minimum of five (5) years from the date of expiration or suspension of this Agreement, or as otherwise required by any applicable law, whichever date is later. The Board shall have the right to order, inspect, and copy all the Records as often as it deems necessary during any such period-of-time. The right to audit, inspect, and copy Records shall include all of the records of sub-Vendors (if any). f. Vendor shall, at all times, comply with the Florida Public Records Law, the Florida Open Meeting Law and all other applicable laws, rules and regulations of the State of Florida. g. IF THE VENDOR HAS QUESTIONS REGARDING THE APPLICATION OF CHAPTER 119, FLORIDA STATUTES, TO THE VENDORS’ DUTY TO PROVIDE PUBLIC RECORDS RELATING TO THIS AGREEMENT, CONTACT THE CUSTODIAN OF PUBLIC RECORDS AT ▇▇▇-▇▇▇-▇▇▇▇, Sumter County Board of County Commissioners, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, Wildwood, Florida 34785 or via email at ▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. h. Vendor shall, at all times, carry General Liability, and Worker’s Compensation Insurance pursuant to the insurance requirements in RFP ▇▇▇-▇-▇▇▇▇/JV, naming Board as both a certificate holder and an additional insured in each such policy. i. Upon Vendor’s written request, the Board will furnish, or cause to be furnished, such reports, studies, instruments, documents, and other information as Vendor and Board mutually deem necessary, and Vendor may rely upon same in performing the services required under this Agreement. j. Vendor is obligated by this agreement to comply with Section 20.055(5), Florida Statutes. k. Any entity or affiliate who has had its Certificate of Qualification suspended, revoked, denied or have further been determined by the Department to be a non-responsive contractor may not submit a bid.

  • Other Considerations A. Changes to an Approved Scope of Work: The Recipient shall notify FEMA and shall require a sub-recipient to notify it immediately when a sub-recipient proposes changes to an approved scope of work for an Undertaking. 1. If FEMA determines the change meets a Programmatic Allowance or has no effect on the property, FEMA shall approve the change. 2. If the change can be modified to meet a Programmatic Allowance, or conform to any applicable SOI Standards, FEMA shall conclude its Section 106 review responsibilities. 3. If FEMA determines that the change does not meet an Allowance, FEMA shall initiate consultation pursuant to Stipulation II.C, Standard Project Review. B. Unexpected Discoveries, Previously Unidentified Properties, or Unexpected Effects: 1. Upon notification by a sub-recipient of an unexpected discovery, or if it appears that a Undertaking has affected a previously unidentified property or affected a known historic property in an unanticipated manner, in accordance with Stipulation I.B.3(e), Recipient Roles and Responsibilities, the Recipient shall immediately notify FEMA and require the sub-recipient to: a. Stop construction activities in the vicinity of the discovery. b. Take all reasonable measures to avoid or minimize harm to the property until FEMA has completed consultation with the SHPO, and any other consulting parties. Upon notification by the Recipient of a discovery, FEMA shall immediately notify the SHPO, and other consulting parties that may have an interest in the discovery, previously unidentified property or unexpected effects, and consult to evaluate the discovery for National Register eligibility and/or the effects of the Undertaking on historic properties. c. If human remains are discovered, notify the local law enforcement office and coroner/medical examiner in accordance with applicable Commonwealth statute(s), and protect the remains from any harm. Notify the SHPO within twenty- four (24) hours of identifying human remains. d. Assist FEMA in completing the following actions, as required: i. FEMA shall consult with the SHPO and other consulting parties in accordance with the consultation process outlined in Stipulation II, Project Review, to develop a mutually agreeable action plan with timeframes to identify the discovery or previously unidentified property, take into account the effect(s) of the Undertaking, resolve adverse effect(s) if necessary, and ensure compliance with applicable Federal, State, and local statutes. ii. FEMA shall coordinate with the Recipient and the sub-recipient regarding any needed modification to the scope of work for the Undertaking necessary to implement recommendations of the consultation and facilitate proceeding with the Undertaking. iii. In cases where discovered human remains are determined to be native to Puerto Rico, FEMA shall follow the guidelines outlined in the ACHP’s Policy Statement Regarding the Treatment of Burial Sites, Human Remains, and Funerary Objects (2007) and any state-specific policies that may be in force. C. Curation 1. FEMA and the Recipient shall ensure that recovered artifacts and related documentation are curated in a suitable repository as agreed to by FEMA and SHPO, following applicable federal guidelines (36 CFR Part 79). 2. When an Undertaking will adversely affect a National Register listed or eligible archaeological site, FEMA may treat the adverse effect by providing for the recovery of significant information through archaeological data recovery. FEMA shall consult with the SHPO and other consulting parties to prepare a research design (data recovery plan), including a specific plan for curation. This plan will incorporate any relevant curation provisions contained in ACHP’s “Recommended Approach for Consultation on Recovery of Significant Information from Archaeological Sites” published in the Federal Register (64 Federal Register 27085-27087 (May 18, 1999)), or other provisions agreed to by the consulting parties. No excavation should be initiated before FEMA acceptance and approval of the curation plan. a. As stipulated in the curation plan, artifacts, as well as field and laboratory records sufficient to document the collection, shall be curated at a facility that meets the standards of, and in accordance with the provisions of 36 CFR Part 79, “Curation of Federally Owned and Administered Archaeological Collections,” and applicable State requirements. D. Review of Undertakings Initiated Before Initiation or Completion of Section 106 Review 1. In accordance with Section 110(k) of the NHPA, FEMA shall not grant assistance to a sub-recipient who, with intent to avoid the requirements of this Agreement or Section 106 of the NHPA, has intentionally significantly and adversely affected a historic property to which the assistance would relate, or having legal power to prevent it, allowed an adverse effect to occur. However, if after consultation with the SHPO and ACHP, FEMA determines that extraordinary circumstances justify granting assistance despite the adverse effect created or permitted by the sub-recipient, FEMA shall complete consultation for the Undertaking pursuant to the terms of this Agreement. 2. FEMA shall specifically advise the Recipient and shall require that the Recipient advise its sub-recipient in writing that they may jeopardize Federal funding if work is performed without all required local, State, and Federal licenses, permits, and/or approvals, including the completion of the Section 106 process. FEMA also shall document this requirement in its Record of Environmental Consideration, as applicable, as well as all project approval documents specifying the project scope and limits, and containing all conditions and caveats. 3. In circumstances where FEMA determines a sub-recipient has initiated an Undertaking without willful intent to avoid the requirements of this Agreement or Section 106 of NHPA, FEMA shall proceed as follows: a. Determine if the Undertaking is of a type for which FEMA has no further Section 106 responsibilities, namely: i. An Undertaking listed in Stipulation I.A.7; or ii. An immediate rescue and salvage operation in accordance with 36 CFR § 800.12(d); or iii. A Programmatic Allowance as described under Stipulation II.A. b. In any such cases listed in Stipulation III.D.3.a., above, FEMA shall document this determination in the project files, and consider the Undertaking Section 106 compliant. c. If FEMA determines the Undertaking would have required Section 106 review, FEMA shall coordinate with the SHPO to determine if consultation is feasible. i. If after coordination with the SHPO, FEMA determines that consultation is feasible, FEMA shall review the Undertaking in accordance with Stipulation II.C, Standard Project Review. ii. If after coordination with the SHPO, FEMA determines that review is infeasible, FEMA shall document the outcome to the Section 106 review process, and the applicable FEMA program shall take the outcome into account before making a decision whether to fund the Undertaking. FEMA shall provide written notification of its funding decision to the Recipient, SHPO and ACHP. 4. FEMA shall ensure that all Undertakings considered for after the fact review in accordance with this stipulation are included in the annual report.

  • Additional Considerations For FEMA’s Assistance to Firefighters Grant (AFG) Program, recipients must include a penalty clause in all contracts for any AFG-funded vehicle, regardless of dollar amount. In that situation, the contract must include a clause addressing that non-delivery by the contract’s specified date or other vendor nonperformance will require a penalty of no less than $100 per day until such time that the vehicle, compliant with the terms of the contract, has been accepted by the recipient. This penalty clause should, however, account for force majeure or acts of God. AFG recipients should refer to the applicable year’s Notice of Funding Opportunity (NOFO) for additional information, which can be accessed at ▇▇▇▇.▇▇▇.

  • MEMO OF CONSIDERATION RECEIVED on the day month and year first above written of and from the within named Purchasers the within mentioned sum of Rs. /- (Rupees only)paid as and by way of full consideration in terms of these presents. 1 By cheque no. dated 2 By cheque no. dated 3 By cheque no. dated 4 By cheque no. dated 5 By cheque no. dated 6 TDS ( ) 7 By cheque no. dated TOTAL (RUPEES ONLY) 1. (OWNERS)