Phase II Study Design in Oncology Drug Development
This study delves into the pivotal role of Phase II trials in oncology drug development, covering statistical parameters, objectives, design elements, sample sizes, and more. Roles of Phase II study, Characteristics of Phase II study, and Overview of Phase II study design are elaborated with insights on trial aims, outcome measures, therapeutic considerations, and trial durations.
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July 2023 Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs) doc.: < 15-23-0336-00-04ab > Submission Title: DS-TWR with MMS Ranging Date Submitted: May, 2023 Source: Rojan Chitrakar, Lei Huang, Bin Qian, David Xun Yang (Huawei Technologies) Email: rojan.chitrakar@huawei.com Abstract: Enabling double-sided two-way ranging (DS-TWR) with MMS ranging Purpose: Enable double-sided two-way ranging (DS-TWR) with MMS ranging Notice: This document has been prepared to assist the IEEE P802.15. It is offered as a basis for discussion and is not binding on the contributing individual(s) or organization(s). The material in this document is subject to change in form and content after further study. The contributor(s) reserve(s) the right to add, amend or withdraw material contained herein. Release: The contributor acknowledges and accepts that this contribution becomes the property of IEEE and may be made publicly available by P802.15. Submission Slide 1 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > PAR Objective Proposed Solution (how addressed) Safeguards so that the high throughput data use cases will not cause significant disruption to low duty-cycle ranging use cases Interference mitigation techniques to support higher density and higher traffic use cases Other coexistence improvement Backward compatibility with enhanced ranging capable devices (ERDEVs) Improved link budget and/or reduced air-time Additional channels and operating frequencies Improvements to accuracy / precision / reliability and interoperability for high-integrity ranging Reduced complexity and power consumption Enabling double-sided two-way ranging (DS-TWR) with MMS ranging for higher accuracy. Hybrid operation with narrowband signaling to assist UWB Enhanced native discovery and connection setup mechanisms Sensing capabilities to support presence detection and environment mapping Low-power low-latency streaming Higher data-rate streaming allowing at least 50 Mbit/s of throughput Support for peer-to-peer, peer-to-multi-peer, and station-to- infrastructure protocols Infrastructure synchronization mechanisms Submission Slide 2 Rojan Chitrakar, et al
July 2023 Background: One-to-many SS-TWR NBA-MMS Ranging [1] doc.: < 15-23-0336-00-04ab > One-to-many SS-TWR NBA-MMS Ranging is introduced in [1]. A ranging round is made up of several access slots. Initiator performs MMS ranging with multiple responders, performing an one-to-one ranging with one responder in each access slot. [1] 15-23/015r2, one to many ranging using MMR technical framework proposal, Jinjing Jiang Submission Slide 3 Rojan Chitrakar, et al
July 2023 Background: Double-Sided Two-Way Ranging (DS-TWR) doc.: < 15-23-0336-00-04ab > DS-TWR (802.15.4z): DS-TWR is an extension of SS-TWR in which two round-trip time measurements are used and combined to give the time-of-flight (TOF) result with a reduced error in the presence of uncorrected clock frequency offset even for quite long response delays. Tprop is the propagation time of the RMARKER between the devices. Submission Slide 4 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > Background: NBA-UWB MMS Packet Three types of NBA-UWB MMS Packet are defined [2]: A single RSF-RMARKER, defined as the peak of the 1st pulse in the 1st RSF, is present in an RSF-Only MMS Packet. RIF-RMARKERs are defined as the peak of the first pulse and the peak of the last pulse in each RIF At least two RMARKERs are present in the Mixed MMS Packet and RIF-Only MMS Packet. [2] 15-23\0100r2, NBA-UWB Technical Framework, Xiliang et. al. Submission Slide 5 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > Motivation The addition of a third (final) message extends the traditional Single-Sided TWR (SS- TWR) to Double-Sided TWR (DS-TWR) and mitigates the effect of relative clock drifts removing the need for carrier offset estimation as in SS-TWR. While the carrier offset estimation is expected to be much more accurate in MMS ranging, enabling DS-TWR with MMS ranging is still beneficial. [3] mentions that SS-TWR may be vulnerable to Mix-Down (MD) Attacks. We explore how DS-TWR can be achieved with MMS ranging with minimal modifications. [3] 15-23\0274r0, More on clock-related attacks against UWB ranging, Claudio Anliker et. al. Submission Slide 6 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > Example Let us take an example of a one-to-many NBA-UWB MMS ranging with 8 responders: Two fragments per MMS packets. Only initiator transmits measurement reports (RPRT frame). Measurement Reporting Phase Measurement Reporting Phase Measurement Reporting Phase Ranging Control Phase Ranging Control Phase Ranging Control Phase Ranging Phase Ranging Phase Ranging Phase ... RPRT POLL RPRT POLL RIM RPRT I I I I I I 10 70 75 15 20 80 Initiator 5 ... NB ... Responder R1 RESP R2 RESP R8 RESP 1 ms 1 ms 1 ms I-1 I-2 I-1 I-2 I-1 I-2 ... 15 20 10 70 75 Initiator 80 5 Legends: UWB ... I Responder R1-1 R1-2 R2-1 R2-2 R8-1 R8-2 Initiators frame 1 ms 1 ms 1 ms Rn ... Access Slot 0 Access Slot 1 Access Slot 8 Responders frame ... One ranging round Submission Slide 7 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > MMS Packets with two or more fragments with RMARKERs Three MMS fragments with RMARKERs are required to compute the timing measurements for DS-TWR: 1st and 3rdare based on initiator s MMS Packets while the 2ndis based on the responders . Mixed MMS Packet or RIF-only MMS Packet with at least two fragments have at least two RMARKERS that can be used to compute the timing measurements for DS-TWR. => A single MMS packet exchange between the initiator and the responder is sufficient for DS-TWR timing measurements. Example: Mixed MMS Packet: 1 RSF + 1 RIF, or RIF-only MMS Packet: 2 RIFs. Initiators Round-trip time of Responder 8 (Tround1_R8) Initiators Reply time of Responder 8 (Treply2_R8) For Mixed MMS Packet: 1st RIF; For RIF-only MMS Packet: 2nd RIF. I-1 I-2 Initiator 1 2 3 UWB Responder R8-1 R8-2 Legend: Reply time of Responder 8 (Treply1_R8) Round-trip time of Responder 8 (Tround2_R8) RMARKER Access Slot 8 Submission Slide 8 Rojan Chitrakar, et al
July 2023 MMS Packets with a single fragment with RMARKER Option 1 doc.: < 15-23-0336-00-04ab > A RIF-Only MMS Packet with a single fragment or a RSF-Only MMS packet has a single fragment with RMARKER(s). For a responder n except the last responder, the first fragment of the initiator s MMS packet to responder n and the first fragment of the initiator s MMS packet to the next responder (responder n+1) can be used as the 3rd RMARKER to compute the timing measurements for DS-TWR. However, this is not possible for the last responder since there is no next responder. Option 1: When MMS packets with a single fragment with RMARKER are used, the initiator transmits one extra MMS packet to enable the DS-TWR timing measurement. 1st Responder Last Responder 2nd Responder Submission Slide 9 Rojan Chitrakar, et al
July 2023 MMS Packets with a single fragment with RMARKER Option 2 doc.: < 15-23-0336-00-04ab > Option 2: When MMS packets with a single fragment with RMARKER are used, the final ranging fragments are transmitted by the initiator. i.e., the fragment interleaving is reversed (responder transmits first, followed by the initiator). DS-TWR timing measurements for the last responder is different: the first fragment of the initiator s MMS packet to the previous responder is used as the 1st RMARKER while the first fragment of the initiator s MMS packet to the last responder is used as the 3rd RMARKER. Last Responder 2nd last Responder fragments interleaving is reversed Initiators Reply time of Responder 8 (Treply2_R8) Initiators Round-trip time of Responder 8 (Tround1_R8) I-1 I-2 I-1 I-2 1 ... 2 3 ... R7-1 R7-2 R8-1 R8-2 Legend: Reply time of Responder 8 (Treply1_R8) RMARKER Round-trip time of Responder 8 (Tround2_R8) ... Access Slot 7 Access Slot 8 Submission Slide 10 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > Measurement Report When applicable, it may be beneficial to consolidate the measurement reports for/from multiple responders in a single RPRT frame and transmit at the end of the ranging round. Report Size: Size of the Reply time field and Turn Around Time fields: (0: 1 octet; 1: 2 octets; 2: 4 octets; 3: 5 octets) DS-TWR: Indicates that both Reply Time and Turn Around Time fields are present. If the Consolidated Measurement Report bit is 1, the Number of Reports field is present and indicates the number of measurement reports in the Measurement Report List, each report carries the measurement report for/from one responder and are arranged in the same order as the transmission order of the corresponding MMS packets in the ranging phase. RPRT Measurement Report Octets: 0, 1, 2, 4 or 5 0, 1, 2, 4 or 5 Octets: 1 3 1 2 variable Turn Around Time Message Control Message Content Reply Time RPA_hash CRC ID Bits:0 - 1 4-7 2 3 Octets: 1 variable 0 or 1 Variable Consolidated Measurement Report DS- TWR Number of Reports Measurement Report List PTDataLength PTData Report Size RFU Submission Slide 11 Rojan Chitrakar, et al
July 2023 doc.: < 15-23-0336-00-04ab > Summary We discussed how DS-TWR can be achieved with MMS ranging with minimal modifications. We proposed two options to enable DS-TWR for MMS Packets with a single fragment with RMARKER: 1. Option 1: the initiator transmits one extra MMS packet at the end of the raging round to enable the DS-TWR timing measurement. 2. Option 2: The final ranging fragments are transmitted by the initiator. i.e., the fragment interleaving is reversed in the last access slot. We also proposed to consolidate the measurement reports for/from multiple responders in a single RPRT frame. Submission Slide 12 Rojan Chitrakar, et al
