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Journal articles on the topic 'Seamless phase II/III'

Author: Grafiati

Published: 4 June 2021

Last updated: 18 February 2022

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1

Stallard, Nigel, and Susan Todd. "Seamless phase II/III designs." Statistical Methods in Medical Research 20, no. 6 (2010): 623–34. http://dx.doi.org/10.1177/0962280210379035.

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In recent years, there has been a drive to save development costs and shorten time-to-market of new therapies. Research into novel trial designs to facilitate this goal has led to, amongst other approaches, the development of methodology for seamless phase II/III designs. Such designs allow treatment or dose selection at an interim analysis and comparative evaluation of efficacy with control, in the same study. Methods have gained much attention because of their potential advantages compared to conventional drug development programmes with separate trials for individual phases. In this article

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2

Spivack, John, Bin Cheng, and Bruce Levin. "Adding dose modifications into Phase II and Phase II/III seamless trials." Statistical Methods in Medical Research 29, no. 5 (2019): 1315–24. http://dx.doi.org/10.1177/0962280219859387.

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We present a technique for adding dose modifications into seamless Phase II and Phase II/III trials featuring dose selection at an interim analysis. The method is convenient to apply and can be used either in a fully prespecified, structured way or as a response to new considerations that emerge at interim. Strong control of the familywise error rate regarding false declarations of efficacy versus control is maintained. Two examples are given. One illustrates how the method could potentially “save” a trial performed in a Phase II context. The other is a seamless Phase II/III trial that uses an

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3

Wang, Lin, and Lu Cui. "Seamless Phase II/III Combination Study Through Response Adaptive Randomization." Journal of Biopharmaceutical Statistics 17, no. 6 (2007): 1177–87. http://dx.doi.org/10.1080/10543400701645322.

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4

Maca, Jeff, Sumon Bhattacharya, Vladimir Dragalin, Paul Gallo, and Michael Krams. "Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples." Drug Information Journal 40, no. 4 (2006): 463–73. http://dx.doi.org/10.1177/216847900604000412.

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5

Bischoff, Wolfgang, and Frank Miller. "A Seamless Phase II/III Design with Sample-Size Re-Estimation." Journal of Biopharmaceutical Statistics 19, no. 4 (2009): 595–609. http://dx.doi.org/10.1080/10543400902963193.

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6

Stallard, Nigel. "Group-Sequential Methods for Adaptive Seamless Phase II/III Clinical Trials." Journal of Biopharmaceutical Statistics 21, no. 4 (2011): 787–801. http://dx.doi.org/10.1080/10543406.2011.551335.

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7

Zhu, Hongjian, Jin Piao, J. Jack Lee, Feifang Hu, and Lixin Zhang. "Response adaptive randomization procedures in seamless phase II/III clinical trials." Journal of Biopharmaceutical Statistics 30, no. 1 (2019): 3–17. http://dx.doi.org/10.1080/10543406.2019.1657439.

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8

Quan, Hui, Xiaodong Luo, Tianyue Zhou, and Peng-Liang Zhao. "Seamless phase II/III/IIIb clinical trial designs with different endpoints for different phases." Communications in Statistics - Theory and Methods 49, no. 22 (2019): 5436–54. http://dx.doi.org/10.1080/03610926.2019.1618871.

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9

Rosenthal, David Ira, Qiang Zhang, Merrill S. Kies, et al. "Seamless phase II/III trial design with survival and PRO endpoints for treatment selection: Case study of RTOG 1216." Journal of Clinical Oncology 31, no. 15_suppl (2013): TPS6099. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.tps6099.

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TPS6099 Background: Clinical trial results from phase II trials to select an experimental treatment arm for separate phase III trial comparison can require years. Cancer clinical trials also now aim at both survival and PRO/functional outcomes, especially in head and neck (HN) studies. We developed a unique seamless phase II/III trial design to save on sample size and trial duration. The initial multi-arm phase II trial selects the most effective regimen among multiple experimental arms by first comparing each of the new treatments to a common control arm, using chosen endpoints, such as progr

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10

Hampson, Lisa V., and Christopher Jennison. "Optimizing the data combination rule for seamless phase II/III clinical trials." Statistics in Medicine 34, no. 1 (2014): 39–58. http://dx.doi.org/10.1002/sim.6316.

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11

Kimani, Peter K., Ekkehard Glimm, Willi Maurer, Jane L. Hutton, and Nigel Stallard. "Practical guidelines for adaptive seamless phase II/III clinical trials that use Bayesian methods." Statistics in Medicine 31, no. 19 (2012): 2068–85. http://dx.doi.org/10.1002/sim.5326.

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12

Stallard, Nigel. "A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information." Statistics in Medicine 29, no. 9 (2010): 959–71. http://dx.doi.org/10.1002/sim.3863.

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13

Kimani, Peter K., Nigel Stallard, and Jane L. Hutton. "Dose selection in seamless phase II/III clinical trials based on efficacy and safety." Statistics in Medicine 28, no. 6 (2009): 917–36. http://dx.doi.org/10.1002/sim.3522.

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14

Kunz, Cornelia Ursula, Tim Friede, Nick Parsons, Susan Todd, and Nigel Stallard. "Data‐driven treatment selection for seamless phase II/III trials incorporating early‐outcome data." Pharmaceutical Statistics 13, no. 4 (2014): 238–46. http://dx.doi.org/10.1002/pst.1619.

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15

Bretz, Frank, Heinz Schmidli, Franz König, Amy Racine, and Willi Maurer. "Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts." Biometrical Journal 48, no. 4 (2006): 623–34. http://dx.doi.org/10.1002/bimj.200510232.

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16

Jennison, Christopher, and Bruce W. Turnbull. "Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: Opportunities and Limitations." Biometrical Journal 48, no. 4 (2006): 650–55. http://dx.doi.org/10.1002/bimj.200610248.

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17

Schmidli, Heinz, Frank Bretz, Amy Racine, and Willi Maurer. "Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: Applications and Practical Considerations." Biometrical Journal 48, no. 4 (2006): 635–43. http://dx.doi.org/10.1002/bimj.200510231.

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18

Inoue, Lurdes Y. T., Peter F. Thall, and Donald A. Berry. "Seamlessly Expanding a Randomized Phase II Trial to Phase III." Biometrics 58, no. 4 (2002): 823–31. http://dx.doi.org/10.1111/j.0006-341x.2002.00823.x.

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19

Jenkins, Martin, Andrew Stone, and Christopher Jennison. "An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints†." Pharmaceutical Statistics 10, no. 4 (2010): 347–56. http://dx.doi.org/10.1002/pst.472.

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20

Leitner, Silvia, Gerald Winter, Jürgen Klarner, Thomas Antretter, and Werner Ecker. "Model-Based Residual Stress Design in Multiphase Seamless Steel Tubes." Materials 13, no. 2 (2020): 439. http://dx.doi.org/10.3390/ma13020439.

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Residual stresses in quenched seamless steel tubes highly depend on the cooling conditions to which the tubes have been subjected. The design aspect of how to use controlled cooling strategies in multiphase steel tubes to achieve certain residual stress and phase configurations is discussed. In an experimentally validated finite element (FE) model considering a coupled evolution of martensite and bainite, three cooling strategies are tested for a low-alloyed 0.25 wt.% C steel tube. The strategies are (i) external cooling only, (ii) internal and external cooling for low residual stresses in a m

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21

Sun, Linda Z., Wen Li, Cong Chen, and Jing Zhao. "Advanced Utilization of Intermediate Endpoints for Making Optimized Cost-Effective Decisions in Seamless Phase II/III Oncology Trials." Statistics in Biopharmaceutical Research 12, no. 2 (2019): 224–33. http://dx.doi.org/10.1080/19466315.2019.1665578.

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22

Robertson, David S., A. Toby Prevost, and Jack Bowden. "Unbiased estimation in seamless phase II/III trials with unequal treatment effect variances and hypothesis-driven selection rules." Statistics in Medicine 35, no. 22 (2016): 3907–22. http://dx.doi.org/10.1002/sim.6974.

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23

Friede, T., N. Parsons, N. Stallard, et al. "Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: An application in multiple sclerosis." Statistics in Medicine 30, no. 13 (2011): 1528–40. http://dx.doi.org/10.1002/sim.4202.

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24

Parsons, Nick, Tim Friede, Susan Todd, et al. "An R package for implementing simulations for seamless phase II/III clinical trials using early outcomes for treatment selection." Computational Statistics & Data Analysis 56, no. 5 (2012): 1150–60. http://dx.doi.org/10.1016/j.csda.2010.10.027.

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25

Gondi, Vinai, Stephanie L. Pugh, Minesh P. Mehta, et al. "NRG Oncology CC003: A randomized phase II/III trial of prophylactic cranial irradiation with or without hippocampal avoidance for small cell lung cancer." Journal of Clinical Oncology 37, no. 15_suppl (2019): TPS8578. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps8578.

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TPS8578 Background: Multiple clinical trials have shown that prophylactic cranial irradiation (PCI) prevents brain metastases and may prolong survival in small cell lung cancer (SCLC). However,prophylactic cranial irradiation can lead to decline in cognitive function. Preclinical evidence suggests that the pathogenesis of this toxicity includes inflammatory injury to proliferating neuronal progenitor cells in the peri-hippocampal stem cell niches. We hypothesized that conformal avoidance of the hippocampal neural stem cell compartment during brain irradiation using intensity-modulated radiothe

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26

Kunz, Cornelia Ursula, Tim Friede, Nicholas Parsons, Susan Todd, and Nigel Stallard. "A Comparison of Methods for Treatment Selection in Seamless Phase II/III Clinical Trials Incorporating Information on Short-Term Endpoints." Journal of Biopharmaceutical Statistics 25, no. 1 (2015): 170–89. http://dx.doi.org/10.1080/10543406.2013.840646.

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27

Brown, Sarah, Jane Nixon, Myka Ransom, et al. "Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial." BMJ Open 10, no. 4 (2020): e035947. http://dx.doi.org/10.1136/bmjopen-2019-035947.

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IntroductionDiabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.Methods and analysisA multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomi

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28

Bothwell, Laura E., Jerry Avorn, Nazleen F. Khan, and Aaron S. Kesselheim. "Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov." BMJ Open 8, no. 2 (2018): e018320. http://dx.doi.org/10.1136/bmjopen-2017-018320.

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ObjectivesThis review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials.DesignReview of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of Controlled Clinical Trials, Web of Science and ClinicalTrials.gov. Phase I and seamless Phase I/II trials were excluded. Variables extracted from trials included basic study characteristics, adaptive design features, size and use of independent data monitoring committees (DMCs) and blinded interim analyses. We also examined use of the adaptive tria

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29

Schrag, Deborah, Martin Weiser, Leonard Saltz, et al. "Challenges and solutions in the design and execution of the PROSPECT Phase II/III neoadjuvant rectal cancer trial (NCCTG N1048/Alliance)." Clinical Trials 16, no. 2 (2019): 165–75. http://dx.doi.org/10.1177/1740774518824539.

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Background More than half of the 40,000 incident rectal cancer patients in the United States each year are diagnosed at clinical stage II and III (locally advanced stage). For this group, high rates of cure can be achieved with the combination of pelvic radiation and sensitizing 5-fluorouracil (chemoradiation), surgery and chemotherapy, but treatment is long, arduous and toxicities are substantial. The PROSPECT trial (N1048, NCT01515787) was designed to determine whether neoadjuvant chemotherapy with 5-fluorouracil and oxaliplatin (FOLFOX) could be used as an alternative to neoadjuvant chemora

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30

Schmidli, Heinz, Frank Bretz, and Amy Racine-Poon. "Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint." Statistics in Medicine 26, no. 27 (2007): 4925–38. http://dx.doi.org/10.1002/sim.2957.

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31

Levin, Bruce, John LP Thompson, Bibhas Chakraborty, Gilberto Levy, Robert MacArthur, and E. Clarke Haley. "Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design." Clinical Trials: Journal of the Society for Clinical Trials 8, no. 4 (2011): 398–407. http://dx.doi.org/10.1177/1740774511410582.

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32

Buxton, Meredith Becker, Brian Michael Alexander, Donald A. Berry, et al. "GBM AGILE: A global, phase II/III adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma." Journal of Clinical Oncology 38, no. 15_suppl (2020): TPS2579. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.tps2579.

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TPS2579 Background: Glioblastoma (GBM) is an aggressive brain tumor with few effective therapies and is invariably fatal. Developing new therapies for patients with GBM requires focused interaction between industry, academia, nonprofits, patient advocacy, and health authorities, and novel approaches to clinical trials. Industry is wary of developing drugs for GBM due to the high failure rate and high cost of drug development. GBM Adaptive Global Innovative Learning Environment (GBM AGILE) Trial was designed by over 130 global key opinion leaders in consultation with health authorities to provi

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33

Trainor, S., T. Wah, C. Ralph, et al. "The Practicalities Involved and Lessons Learned in the Transition from Central to Local Radiology Reporting in the Context of a Seamless Phase II/III Clinical Trial." Clinical Oncology 29, no. 3 (2017): e89. http://dx.doi.org/10.1016/j.clon.2016.11.025.

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34

Chiang, Min-Yu, Yao-Wen Hsu, Hsin-Yi Hsieh, San-Yuan Chen, and Shih-Kang Fan. "Constructing 3D heterogeneous hydrogels from electrically manipulated prepolymer droplets and crosslinked microgels." Science Advances 2, no. 10 (2016): e1600964. http://dx.doi.org/10.1126/sciadv.1600964.

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Formation of multifunctional, heterogeneous, and encoded hydrogel building blocks, or microgels, by crosslinking and assembly of microgels are two essential steps in establishing hierarchical, complicated, and three-dimensional (3D) hydrogel architectures that recapitulate natural and biological structures or originate new materials by design. However, for the variety of the hydrogel materials crosslinked differently and for the varied scales of microgels and architectures, the formation and assembly processes are usually performed separately, which increases the manufacturing complexity of de

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35

Casula, Daniela, Andrea Callegaro, Phoebe Nakanwagi, Vincent Weynants, and Ashwani Kumar Arora. "Evaluation of an Adaptive Seamless Design for a Phase II/III Clinical Trial in Recurrent Events Data to Demonstrate Reduction in Number of Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)." Statistics in Biopharmaceutical Research 12, no. 3 (2020): 273–78. http://dx.doi.org/10.1080/19466315.2020.1764382.

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36

Xavier, Prince K., Jean-Philippe Duvel, Pascale Braconnot, and Francisco J. Doblas-Reyes. "An Evaluation Metric for Intraseasonal Variability and its Application to CMIP3 Twentieth-Century Simulations." Journal of Climate 23, no. 13 (2010): 3497–508. http://dx.doi.org/10.1175/2010jcli3260.1.

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Abstract The intraseasonal variability (ISV) is an intermittent phenomenon with variable perturbation patterns. To assess the robustness of the simulated ISV in climate models, it is thus interesting to consider the distribution of perturbation patterns rather than only one average pattern. To inspect this distribution, the authors first introduce a distance that measures the similarity between two patterns. The reproducibility (realism) of the simulated intraseasonal patterns is then defined as the distribution of distances between each pattern and the average simulated (observed) pattern. A

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37

Tomizawa, Daisuke, Shiro Tanaka, Daisuke Hasegawa, et al. "Evaluation of high-dose cytarabine in induction therapy for children with de novo acute myeloid leukemia: a study protocol of the Japan Children’s Cancer Group Multi-Center Seamless Phase II–III Randomized Trial (JPLSG AML-12)." Japanese Journal of Clinical Oncology 48, no. 6 (2018): 587–93. http://dx.doi.org/10.1093/jjco/hyy061.

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38

Subramaniam, Shalini, Guy C. Toner, Martin R. Stockler, et al. "P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs)." Journal of Clinical Oncology 39, no. 6_suppl (2021): TPS390. http://dx.doi.org/10.1200/jco.2021.39.6_suppl.tps390.

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TPS390 Background: Bleomycin, etoposide, and cisplatin (BEP) given 3-weekly x 4 is standard first-line chemotherapy for metastatic GCT categorised as intermediate risk or poor risk. Acceleration of standard regimens by shortening the cycle length improved cure rates in other cancers. We aim to determine the superiority of accelerated BEP versus standard BEP in this setting. Methods: This open label, randomised, phase III trial is conducted seamlessly in 2-stages. The primary endpoint for stage I (n=150) is complete response (CR); and for stage II (n=500) is progression free survival at 2 years

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39

Pan, Haitao, Ping Huang, Zuoren Wang, Ling Wang, Chanjuan Li, and Jielai Xia. "A Novel Bayesian Seamless Phase I/II Design." PLoS ONE 8, no. 9 (2013): e73060. http://dx.doi.org/10.1371/journal.pone.0073060.

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40

Teh, Su Yean, Hock Lye Koh, and Yong Hui Lim. "High-Resolution Digital Elevation and Bathymetry Model for Tsunami Run-Up and Inundation Simulation in Penang." Journal of Earthquake and Tsunami 13, no. 05n06 (2019): 1941001. http://dx.doi.org/10.1142/s179343111941001x.

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Many beaches in Penang island were severely inundated by the 26 December 2004 Indian Ocean mega tsunami with 57 deaths recorded. It is anticipated that the next big tsunami will cause even more damages to beaches in Penang. Hence, developing community resilience against the risks of the next tsunami is essential. Resilience entails many interlinked components, beginning with a good understanding of the inundation scenarios critical to community evacuation and resilience preparation. Inundation scenarios are developed from tsunami simulations involving all three phases of tsunami generation, pr

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41

Fazzari, Melissa, Glenn Heller, and Howard I. Scher. "The Phase II/III Transition." Controlled Clinical Trials 21, no. 4 (2000): 360–68. http://dx.doi.org/10.1016/s0197-2456(00)00056-8.

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42

Chen, Y. H. Joshua, Richard Gesser, and Alain Luxembourg. "A seamless Phase IIB/III adaptive outcome trial: Design rationale and implementation challenges." Clinical Trials: Journal of the Society for Clinical Trials 12, no. 1 (2014): 84–90. http://dx.doi.org/10.1177/1740774514552110.

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43

Harrison, Richard K. "Phase II and phase III failures: 2013–2015." Nature Reviews Drug Discovery 15, no. 12 (2016): 817–18. http://dx.doi.org/10.1038/nrd.2016.184.

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44

&NA;. "Lamivudine to enter phase II/III." Inpharma Weekly &NA;, no. 881 (1993): 8. http://dx.doi.org/10.2165/00128413-199308810-00018.

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45

Pan, Haitao, Fang Xie, Ping Liu, Jielai Xia, and Yuan Ji. "A phase I/II seamless dose escalation/expansion with adaptive randomization scheme (SEARS)." Clinical Trials: Journal of the Society for Clinical Trials 11, no. 1 (2013): 49–59. http://dx.doi.org/10.1177/1740774513500081.

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46

Wages, Nolan A., and Christopher Tait. "Seamless Phase I/II Adaptive Design for Oncology Trials of Molecularly Targeted Agents." Journal of Biopharmaceutical Statistics 25, no. 5 (2014): 903–20. http://dx.doi.org/10.1080/10543406.2014.920873.

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47

Yan, Donglin, Nolan A. Wages, and Emily V. Dressler. "Improved adaptive randomization strategies for a seamless Phase I/II dose-finding design." Journal of Biopharmaceutical Statistics 29, no. 2 (2018): 333–47. http://dx.doi.org/10.1080/10543406.2018.1535496.

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48

Biard, Lucie, Shing M. Lee, and Bin Cheng. "Seamless phase I/II design for novel anticancer agents with competing disease progression." Statistics in Medicine 40, no. 21 (2021): 4568–81. http://dx.doi.org/10.1002/sim.9080.

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Boonstra, Philip S., Thomas M. Braun, and Elizabeth C. Chase. "A modular framework for early-phase seamless oncology trials." Clinical Trials 18, no. 3 (2021): 303–13. http://dx.doi.org/10.1177/1740774520981939.

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Background: As our understanding of the etiology and mechanisms of cancer becomes more sophisticated and the number of therapeutic options increases, phase I oncology trials today have multiple primary objectives. Many such designs are now “seamless,” meaning that the trial estimates both the maximum tolerated dose and the efficacy at this dose level. Sponsors often proceed with further study only with this additional efficacy evidence. However, with this increasing complexity in trial design, it becomes challenging to articulate fundamental operating characteristics of these trials, such as (

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50

Arrowsmith, John, and Philip Miller. "Phase II and Phase III attrition rates 2011–2012." Nature Reviews Drug Discovery 12, no. 8 (2013): 569. http://dx.doi.org/10.1038/nrd4090.

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