Literature DB >> 21651388

New FDA regulation to improve safety reporting in clinical trials.

Rachel Behrman Sherman1, Janet Woodcock, Janet Norden, Cheryl Grandinetti, Robert J Temple.   

Abstract

Mesh：

Year:  2011        PMID： 21651388     DOI： 10.1056/NEJMp1103464

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


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  16 in total

1.  Registries, research, and regrets: is the FDA's post-marketing REMS process not adequately protecting patients?

Authors:  Norman J Kachuck
Journal:  Ther Adv Neurol Disord       Date:  2011-11       Impact factor: 6.570

Review 2.  Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice.

Authors:  M Angelyn Bethel; Harald Sourij
Journal:  Curr Cardiol Rep       Date:  2012-02       Impact factor: 2.931

3.  Phase I Designs that Allow for Uncertainty in the Attribution of Adverse Events.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  J R Stat Soc Ser C Appl Stat       Date:  2016-11-07       Impact factor: 1.864

Review 4.  Benefit and harms of new anti-cancer drugs.

Authors:  Francisco E Vera-Badillo; Mustafa Al-Mubarak; Arnoud J Templeton; Eitan Amir
Journal:  Curr Oncol Rep       Date:  2013-06       Impact factor: 5.075

5.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher
Journal:  BMJ       Date:  2013-01-08

6.  Clinical trials: innovation, progress and controversy.

Authors:  Greg S Martin
Journal:  Open Access J Clin Trials       Date:  2011-08

Review 7.  Breast cancer metastasis: issues for the personalization of its prevention and treatment.

Authors:  Natascia Marino; Stephan Woditschka; L Tiffany Reed; Joji Nakayama; Musa Mayer; Maria Wetzel; Patricia S Steeg
Journal:  Am J Pathol       Date:  2013-07-26       Impact factor: 4.307

8.  Analogs of penfluridol as chemotherapeutic agents with reduced central nervous system activity.

Authors:  Md Ashraf-Uz-Zaman; Md Sanaullah Sajib; Luca Cucullo; Constantinos M Mikelis; Nadezhda A German
Journal:  Bioorg Med Chem Lett       Date:  2018-10-24       Impact factor: 2.823

9.  Xanthohumol Microbiome and Signature in Healthy Adults (the XMaS Trial): Safety and Tolerability Results of a Phase I Triple-Masked, Placebo-Controlled Clinical Trial.

Authors:  Blake O Langley; Jennifer Joan Ryan; Douglas Hanes; John Phipps; Emily Stack; Thomas O Metz; J Frederik Stevens; Ryan Bradley
Journal:  Mol Nutr Food Res       Date:  2021-03-11       Impact factor: 5.914

Review 10.  Drug safety assessment in clinical trials: methodological challenges and opportunities.

Authors:  Sonal Singh; Yoon K Loke
Journal:  Trials       Date:  2012-08-20       Impact factor: 2.279
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