Literature DB >> 29105757

Transforming the Activation of Clinical Trials.

Julie T Watters1, Jason H Pitzen1, Linda J Sanders1, Virginia Nickie M Bruce2, Alissa R Cornell1, Gary C Cseko1, Janice S Grace1, Pamela S Kwon1, Andrea K Kukla1, Michael S Lee3, Michelle D Monosmith4, John D Myren1, Rebecca S Kottschade5, Marc N Shaft1, Jennifer Jenny A Weis1, Jane C Welter1, Adil E Bharucha6.   

Abstract

The Institute of Medicine and US Food and Drug Administration (FDA) recognize that activating clinical trials in the United States is lengthy and inefficient. Downstream consequences include increased expense, suboptimal accrual, move of clinical trials overseas, and delayed availability of treatments for patients. An in-tandem processing initiative is here highlighted that transformed the activation of clinical trials (TACT), reduced the activation time by 70%, and offers a paradigm for enhanced translational readiness.
© 2017 American Society for Clinical Pharmacology and Therapeutics.

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Year:  2017        PMID: 29105757      PMCID: PMC5774626          DOI: 10.1002/cpt.898

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  2 in total

1.  Improving cardiovascular clinical trials conduct in the United States: recommendation from clinicians, researchers, sponsors, and regulators.

Authors:  Javed Butler; Gregg C Fonarow; Christopher O'Connor; Kirkwood Adams; Robert O Bonow; Robert J Cody; Sean P Collins; Preston Dunnmon; Wilfried Dinh; Mona Fiuzat; Vasiliki V Georgiopoulou; Stephen Grant; So-Young Kim; Stuart Kupfer; Martin Lefkowitz; Robert J Mentz; Frank Misselwitz; Bertram Pitt; Lothar Roessig; Erik Schelbert; Monica Shah; Scott Solomon; Norman Stockbridge; Clyde Yancy; Mihai Gheorghiade
Journal:  Am Heart J       Date:  2014-12-17       Impact factor: 4.749

2.  Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials.

Authors:  David M Dilts; Alan B Sandler
Journal:  J Clin Oncol       Date:  2006-10-01       Impact factor: 44.544

  2 in total
  3 in total

1.  Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.

Authors:  Maria Alice Franzoi; Marion Procter; Chris Twelves; Noam Ponde; Daniel Eiger; Orianne Emond; Emma Clark; Damien Parlier; Sébastien Guillaume; Linda Reaby; Evandro de Azambuja; Jose Bines
Journal:  Ecancermedicalscience       Date:  2022-04-29

2.  COVID-19 Ethics and Research.

Authors:  Karen M Meagher; Nathan W Cummins; Adil E Bharucha; Andrew D Badley; Linda L Chlan; R Scott Wright
Journal:  Mayo Clin Proc       Date:  2020-04-24       Impact factor: 7.616

3.  Participation of rural patients in clinical trials at a multisite academic medical center.

Authors:  Adil E Bharucha; Chung Il Wi; Sushmitha Grama Srinivasan; Hyuckjae Choi; Phillip H Wheeler; Jennifer R Stavlund; Daniel A Keller; Kent R Bailey; Young J Juhn
Journal:  J Clin Transl Sci       Date:  2021-07-12
  3 in total

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