This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; 'Confirmatory clinical trials with an adaptive design' by Armin Koch; and 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/bimj.200610240 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Context-dependent effects of CDKN2A and other 9p21 gene losses during the evolution of esophageal cancer.
Nat Cancer
January 2025
Cancer Systems Biology Laboratory, The Francis Crick Institute, London, UK.
CDKN2A is a tumor suppressor located in chromosome 9p21 and frequently lost in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC). How CDKN2A and other 9p21 gene co-deletions affect EAC evolution remains understudied. We explored the effects of 9p21 loss in EACs and cancer progressor and non-progressor BEs with matched genomic, transcriptomic and clinical data.
View Article and Find Full Text PDFPrimary thymic mucosa-associated lymphoid tissue (MALT) lymphoma with Sjogren's syndrome and diffuse cystic lung disease: a complex respiratory presentation of a multifaceted autoimmune disease.
BMJ Case Rep
December 2024
University of New South Wales Faculty of Medicine, Sydney, New South Wales, Australia
Article Synopsis
- - Mucosa-associated lymphoid tissue (MALT) lymphoma is a rare B-cell lymphoma that can affect various organs, and patients with Sjögren's syndrome (SjS) have significantly higher risks of developing it.
- - A case study is presented of primary thymic MALT lymphoma found incidentally during routine chest imaging, alongside cystic lung disease, primarily observed in women with SjS.
- - Imaging techniques revealed a large mass in the mediastinum and numerous pulmonary cysts; the diagnosis was confirmed via biopsy, and treatment improved lung function, emphasizing the link between SjS and MALT lymphoma's lung manifestations.
Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose.
Vaccine
January 2025
Pfizer R&D UK Limited, Orega, Marlow International, Parkway, Marlow, SL7 1YL, UK,. Electronic address:
Background: Vaccination against 5 prominent meningococcal serogroups (A/B/C/W/Y) is necessary for broad disease protection. We report immunopersistence through 4 years after a 2-dose (6-month interval) pentavalent MenABCWY primary vaccine series and safety and immunogenicity of a booster administered 4 years after primary vaccination.
Methods: This randomized, active-controlled, observer-blinded study was conducted in the United States and Europe.
Herpetic Esophagitis: A Painful Diagnosis in an Immunocompetent Male.
J Gastrointestin Liver Dis
September 2024
St Vincent's Hospital, Department of Gastroenterology and Hepatology, Sydney, Australia.
Successful endoscopic decompression of an intramural duodenal hematoma secondary to pancreatitis causing duodenal and common bile duct obstruction.
Minerva Gastroenterol (Torino)
September 2024
Department of Gastroenterology, St Vincent's Hospital, Darlinghurst, Australia.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!