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Literature DB >> 18768938

Identifying and addressing safety signals in clinical trials.

Thomas R Fleming.

Abstract

Entities: Chemical Disease Gene Species

Mesh：

Substances：

Year: 2008 PMID： 18768938 PMCID： PMC2703718 DOI： 10.1056/NEJMe0807372

Source DB: PubMed Journal: N Engl J Med ISSN： 0028-4793 Impact factor: 91.245

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8 in total

1. Current issues in non-inferiority trials.

Authors: Thomas R Fleming
Journal: Stat Med Date: 2008-02-10 Impact factor: 2.373

2. Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance.

Authors: R T O'Neill
Journal: Control Clin Trials Date: 1997-12

Review 3. Phytosterols as anticancer compounds.

Authors: Peter G Bradford; Atif B Awad
Journal: Mol Nutr Food Res Date: 2007-02 Impact factor: 5.914

4. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.

Authors: Anne B Rossebø; Terje R Pedersen; Kurt Boman; Philippe Brudi; John B Chambers; Kenneth Egstrup; Eva Gerdts; Christa Gohlke-Bärwolf; Ingar Holme; Y Antero Kesäniemi; William Malbecq; Christoph A Nienaber; Simon Ray; Terje Skjaerpe; Kristian Wachtell; Ronnie Willenheimer
Journal: N Engl J Med Date: 2008-09-02 Impact factor: 91.245

5. Analyses of cancer data from three ezetimibe trials.

Authors: Richard Peto; Jonathan Emberson; Martin Landray; Colin Baigent; Rory Collins; Robert Clare; Robert Califf
Journal: N Engl J Med Date: 2008-09-02 Impact factor: 91.245

6. Maintaining confidentiality of interim data to enhance trial integrity and credibility.

Authors: Thomas R Fleming; Katrina Sharples; John McCall; Andrew Moore; Anthony Rodgers; Ralph Stewart
Journal: Clin Trials Date: 2008 Impact factor: 2.486

7. Chemoprevention of tumor metastasis by liposomal beta-sitosterol intake.

Authors: Hiromichi Imanaka; Hiroyuki Koide; Kosuke Shimizu; Tomohiro Asai; Naomi Kinouchi Shimizu; Atsushi Ishikado; Taketoshi Makino; Naoto Oku
Journal: Biol Pharm Bull Date: 2008-03 Impact factor: 2.233

8. Effects of ezetimibe, simvastatin, atorvastatin, and ezetimibe-statin therapies on non-cholesterol sterols in patients with primary hypercholesterolemia.

Authors: Gerd Assmann; Frank Kannenberg; Dena R Ramey; Thomas A Musliner; Stephen W Gutkin; Enrico P Veltri
Journal: Curr Med Res Opin Date: 2008-01 Impact factor: 2.580

8 in total

11 in total

1. The Food and Drug Administration and the Future of Drug Development for the Treatment of Diabetes.

Authors: Eric P Brass
Journal: Diabetes Spectr Date: 2014-05

2. Drug therapies for the primary prevention of cardiovascular events: trials and errors: 2009 Ancel Keys Memorial Lecture.

Authors: Bruce M Psaty
Journal: Circulation Date: 2010-02-23 Impact factor: 29.690

3. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.

Authors: S Elizabeth Williams; Barbara A Pahud; Claudia Vellozzi; Peter D Donofrio; Cornelia L Dekker; Neal Halsey; Nicola P Klein; Roger P Baxter; Colin D Marchant; Philip S Larussa; Elizabeth D Barnett; Jerome I Tokars; Brian E McGeeney; Robert C Sparks; Laurie L Aukes; Kathleen Jakob; Silvia Coronel; James J Sejvar; Barbara A Slade; Kathryn M Edwards
Journal: Vaccine Date: 2011-09-03 Impact factor: 3.641

Identifying and addressing safety signals in clinical trials.

1. Current issues in non-inferiority trials.

2. Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance.

Review 3. Phytosterols as anticancer compounds.

4. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.

5. Analyses of cancer data from three ezetimibe trials.

6. Maintaining confidentiality of interim data to enhance trial integrity and credibility.

7. Chemoprevention of tumor metastasis by liposomal beta-sitosterol intake.

8. Effects of ezetimibe, simvastatin, atorvastatin, and ezetimibe-statin therapies on non-cholesterol sterols in patients with primary hypercholesterolemia.

1. The Food and Drug Administration and the Future of Drug Development for the Treatment of Diabetes.

2. Drug therapies for the primary prevention of cardiovascular events: trials and errors: 2009 Ancel Keys Memorial Lecture.

3. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.

4. The evidence on trial: cholesterol lowering and cancer.

Review 5. Essential statistical principles of clinical trials of pain treatments.

6. Addressing missing data in clinical trials.

7. Protecting the confidentiality of interim data: addressing current challenges.

8. Statin-induced diabetes: will it change clinical practice?

9. Statin therapy and risk of developing type 2 diabetes: a meta-analysis.

10. Relationship between atorvastatin dose and the harm caused by torcetrapib.