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Statistical Methods for Assessment of Complex Generic Drugs
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Johnson and Schwartz (Johnson & Schwartz, 2018) reported two BE studies, sponsored by GlaxoSmithKline (GSK), for comparison of orlistat chewable tablet and capsule formulation. Though these two studies are not for development of generic drugs, the study design and statistical method are consistent with the BE study for generic drugs. Both studies are designed following the recommendation of PSG for orlistat. A randomized, 3-period, 3-treatment (Latin square) crossover design is employed. Healthy males and non-pregnant females are recruited and then experience a run-in period of controlled diet and no drug for six days. Following the run-in period, subjects were randomly allocated into three sequences and received orlistat 27-mg chewable tablet, orlistat 60-mg capsule, or orlistat 120 mg (2 60-mg capsules) in each treatment period. Standardized daily diet containing a total of 70 g of fat and 2200 calories was provided during the study period. Each of the three treatment periods lasted nine days and was separated by a washout period of two days. It should be noted that the FDA PSG recommends that the washout should be at least four days.
Perspective on Clinical Trials for Dermal Drug Delivery Systems
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
John T. Farrar, Shamir N. Kalaria
Another consideration for the selection of a population is the potential usefulness of a pre-randomization testing of procedures, treatments or placebo using a run-in period. Each has its own issues and concerns. The procedure testing run-in period can be an important process to avoid protocol violations during the study, especially for complex studies. This run-in period involves having the potential subject go through the study process, including data collection, application of a dummy transdermal medications or device, and interaction with the study staff to ensure that the subjects are willing and able to carry out the necessary procedures for the study. This can often be combined with the collection of the study qualifying or baseline measurement data but may need a separate consent form, depending on the complexity of the procedures. It is much better to exclude patients who cannot appropriately complete the study requirements before their randomization than later in the study.
Sequential Multiple Assignment Randomized Trials
Published in Anastasios A. Tsiatis, Marie Davidian, Shannon T. Holloway, Eric B. Laber, Dynamic Treatment Regimes, 2019
Anastasios A. Tsiatis, Marie Davidian, Shannon T. Holloway, Eric B. Laber
One motivation for conducting a SMART is to develop a principled, evidence-based treatment strategy for patients who fail to respond to a standard treatment. In such settings, all subjects may be assigned initially to a standard treatment in a “run-in” period, and nonresponders are then randomized to potential follow-up treatments.
Lactobacillus rhamnosus CNCM I-3690 decreases subjective academic stress in healthy adults: a randomized placebo-controlled trial
Published in Gut Microbes, 2022
Lucas Wauters, Luka Van Oudenhove, Alison Accarie, Karlien Geboers, Hannelore Geysen, Joran Toth, Anja Luypaerts, Kristin Verbeke, Tamara Smokvina, Jeroen Raes, Jan Tack, Tim Vanuytsel
After a screening visit for eligibility, a run-in period of minimum 15 days took place prior to randomization. A baseline visit >1 month (D-35 to D-27) and a second visit 2 weeks before the thesis defense (D-14 ± 1 day) were planned with collection of samples and questionnaires. On the day of the thesis defense (D0), additional samples and questionnaires were obtained to evaluate the effect of the stressor. A final visit was planned 2 weeks after the thesis (D + 14 ± 1 day), with routine procedures after intake of indomethacin, a non-steroidal anti-inflammatory drug (NSAID), as a positive control to increase the intestinal permeability.15 This was followed by a safety follow-up phone call after 1 to 2 weeks to check for potential adverse events. The trial was conducted according to the Declaration of Helsinki and Good Clinical Practice regulations after approval by the Ethics Committee of University Hospitals Leuven (number S60969). Written informed consent was obtained from each study participant before inclusion. All data were collected at KU Leuven and University Hospitals Leuven (Leuven, Belgium).
Platelets: the point of interconnection among cancer, inflammation and cardiovascular diseases
Published in Expert Review of Hematology, 2021
Massimiliano Camilli, Giulia Iannaccone, Giulia La Vecchia, Luigi Cappannoli, Roberto Scacciavillani, Giorgio Minotti, Massimo Massetti, Filippo Crea, Nadia Aspromonte
Over the last years, a new potential therapeutic application of aspirin has been proposed, whereas as adjuvant treatment in patients with different types of cancers and results from several ongoing clinical trials will hopefully provide more data in this regard within few years [88–90]. Among those, the Aspirin for Dukes C and high risk Dukes B colorectal cancer (ASCOLT) trial investigated the use of aspirin 200 mg for 3 years versus placebo as adjuvant therapy after completion surgery treatment and standard adjuvant chemotherapy (with or without radiotherapy) in improving disease free survival and overall survival rates up among patients with invasive CRC [88]. Over different scenarios, in the Add-Aspirin trial patients among four cohorts of breast (n = 3100), colorectal (n = 2600), gastro-esophageal (n = 2100) and prostate cancer (n = 2120) who underwent all standard curative treatments were randomized to either aspirin 300 mg, aspirin 100 mg or placebo for at least 5 years to investigate the potential use of this medication as additional adjuvant therapy [88]. Preliminary findings after two years of enrollment revealed encouraging results about recruitment rates to randomization (85% of patients who ended the run-in period), adherence (95% of participants) and toxicity, with no upper gastrointestinal bleedings after run-in phase recorded [90].
Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial
Published in Current Medical Research and Opinion, 2021
Jinping Zheng, Nanshan Zhong, Changzheng Wang, Li Ping Wei, Xiang Dong Zhou, Li Zhao, Ya Dong Yuan, Bei He, Bin Wu, Xin Du, Jie Song, David A. Lipson
The IMPACT trial (GSK study CTT116855, NCT02164513) is a Phase III, randomized, double-blind, parallel-group, multicenter trial conducted in 37 countries between June 2014 and July 2017. Here we report a subgroup analysis in patients from China. The trial design has been described in detail previously10,16. Briefly, the total trial duration was approximately 55 weeks, consisting of a 2-week run-in period, a 52-week treatment period, and a 1-week safety follow-up period. All patients in the overall ITT population provided written informed consent. The trial was conducted in accordance with Good Clinical Practice guidelines and the provisions of the Declaration of Helsinki and received approval from local institutional review boards or independent ethics committees.