Literature DB >> 22047648

Implementing clinical trials on an international platform: challenges and perspectives.

Greg Minisman1, Minal Bhanushali, Robin Conwit, Gil I Wolfe, Inmaculada Aban, Henry J Kaminski, Gary Cutter.   

Abstract

The importance of conducting medical research on a global or international platform cannot be overemphasized in current times. Sponsors are encouraging international clinical trials for a number of reasons. Globally, clinical trials are under increasing pressure to meet patient recruitment goals quickly and efficiently, at times with very limited resources. Conducting clinical trials in multiple countries increases access to potentially eligible study subjects. It is reasonable to believe that international trials will be completed more quickly and efficiently, leading to more rapid advancement in science and conservation of research-specific resources. Rapid advancement in science can reduce the burden of disease, promote health, and extend longevity for all people. In addition, generalizability, one of the major goals of translational medicine, will increase when recruiting patients from multiple countries and multiple ethnicities. Further, improvement of global health may be possible when certain types of clinical trials are conducted in countries that would not otherwise have access to an innovative drug or intervention. Published by Elsevier B.V.

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Year:  2011        PMID: 22047648      PMCID: PMC3254780          DOI: 10.1016/j.jns.2011.10.004

Source DB:  PubMed          Journal:  J Neurol Sci        ISSN: 0022-510X            Impact factor:   3.181


  9 in total

Review 1.  Clinical Trials Legislation - preparing for the revision of the European Directive Scheduled for 2011.

Authors:  Pascal Bilbault; Chantal Belorgey; Faiez Zannad; Danielle Golinelli; Yannick Pletan
Journal:  Therapie       Date:  2010-09-21       Impact factor: 2.070

2.  Damage to important clinical trials by over-regulation.

Authors:  Salim Yusuf
Journal:  Clin Trials       Date:  2010-12       Impact factor: 2.486

Review 3.  Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases.

Authors:  Thomas J Bollyky; Iain M Cockburn; Ernst Berndt
Journal:  Clin Trials       Date:  2010-11-25       Impact factor: 2.486

4.  Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health.

Authors:  James D Neaton; Abdel Babiker; Mark Bohnhorst; Janet Darbyshire; Eileen Denning; Arnie Frishman; Jesper Grarup; Gregg Larson; Jens Lundgren
Journal:  Clin Trials       Date:  2010-08-20       Impact factor: 2.486

5.  Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions.

Authors:  Laura Mauri; Dean J Kereiakes; Sharon-Lise T Normand; Stephen D Wiviott; David J Cohen; David R Holmes; Sripal Bangalore; Donald E Cutlip; Michael Pencina; Joseph M Massaro
Journal:  Am Heart J       Date:  2010-12       Impact factor: 4.749

6.  The MGTX experience: challenges in planning and executing an international, multicenter clinical trial.

Authors:  Inmaculada B Aban; Gil I Wolfe; Gary R Cutter; Henry J Kaminski; Alfred Jaretzki; Greg Minisman; Robin Conwit; John Newsom-Davis
Journal:  J Neuroimmunol       Date:  2008-09-15       Impact factor: 3.478

7.  Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of an international phase III trial: Abciximab in Emergency Treatment of Stroke Trial (AbESTT-II).

Authors:  Harold P Adams; Mark B Effron; James Torner; Antoni Dávalos; Judith Frayne; Philip Teal; Jacques Leclerc; Barry Oemar; Lakshmi Padgett; Elliot S Barnathan; Werner Hacke
Journal:  Stroke       Date:  2007-11-21       Impact factor: 7.914

Review 8.  International collaboration is feasible in trials for rare conditions: the EURAMOS experience.

Authors:  N Marina; S Bielack; J Whelan; S Smeland; M Krailo; M R Sydes; T Butterfass-Bahloul; G Calaminus; M Bernstein
Journal:  Cancer Treat Res       Date:  2009

9.  Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN).

Authors:  Christine Kubiak; Fernando de Andres-Trelles; Wolfgang Kuchinke; Karl-Heinz Huemer; Steffen Thirstrup; Kate Whitfield; Christian Libersa; Béatrice Barraud; Xina Grählert; Gabriele Dreier; Ruth Grychtol; Zsuzsa Temesvari; Gyorgy Blasko; Gabriella Kardos; Timothy O'Brien; Margaret Cooney; Siobhan Gaynor; Arrigo Schieppati; Nuria Sanz; Raquel Hernandez; Charlotte Asker-Hagelberg; Hanna Johansson; Sue Bourne; Jane Byrne; Adeeba Asghar; Jean-Marc Husson; Christian Gluud; Jacques Demotes-Mainard
Journal:  Trials       Date:  2009-10-16       Impact factor: 2.279

  9 in total
  13 in total

Review 1.  Biomarker development for myasthenia gravis.

Authors:  Henry J Kaminski; Linda L Kusner; Gil I Wolfe; Inmaculada Aban; Greg Minisman; Robin Conwit; Gary Cutter
Journal:  Ann N Y Acad Sci       Date:  2012-12       Impact factor: 5.691

2.  Mexiletine for treatment of myotonia: a trial triumph for rare disease networks.

Authors:  Eric P Hoffman; Henry J Kaminski
Journal:  JAMA       Date:  2012-10-03       Impact factor: 56.272

3.  Insurance in clinical research.

Authors:  Ravindra B Ghooi; Deepa Divekar
Journal:  Perspect Clin Res       Date:  2014-10

Review 4.  A checklist for clinical trials in rare disease: obstacles and anticipatory actions-lessons learned from the FOR-DMD trial.

Authors:  Rebecca A Crow; Kimberly A Hart; Michael P McDermott; Rabi Tawil; William B Martens; Barbara E Herr; Elaine McColl; Jennifer Wilkinson; Janbernd Kirschner; Wendy M King; Michele Eagle; Mary W Brown; Deborah Hirtz; Hanns Lochmuller; Volker Straub; Emma Ciafaloni; Perry B Shieh; Stefan Spinty; Anne-Marie Childs; Adnan Y Manzur; Lucia Morandi; Russell J Butterfield; Iain Horrocks; Helen Roper; Kevin M Flanigan; Nancy L Kuntz; Jean K Mah; Leslie Morrison; Basil T Darras; Maja von der Hagen; Ulrike Schara; Ekkehard Wilichowski; Tiziana Mongini; Craig M McDonald; Giuseppe Vita; Richard J Barohn; Richard S Finkel; Matthew Wicklund; Hugh J McMillan; Imelda Hughes; Elena Pegoraro; W Bryan Burnette; James F Howard; Mathula Thangarajh; Craig Campbell; Robert C Griggs; Kate Bushby; Michela Guglieri
Journal:  Trials       Date:  2018-05-10       Impact factor: 2.279

5.  An investigation into the factors affecting investigator-initiated trial start-up in Ireland.

Authors:  Lauren Leddy; Prasanth Sukumar; Lydia O'Sullivan; Fionnuala Keane; Declan Devane; Peter Doran
Journal:  Trials       Date:  2020-11-23       Impact factor: 2.279

6.  The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.

Authors:  L Horavova; K Nebeska; L Souckova; R Demlova; P Babula
Journal:  Ther Innov Regul Sci       Date:  2020-06-05       Impact factor: 1.778

Review 7.  Publication of oral and video presentations from the Society of Gynecologic Oncology annual meeting over 11 years - What characteristics were important?

Authors:  Anthony A Milki; Joshua G Cohen; Amandeep Kaur Mann; Daniel S Kapp; John K Chan
Journal:  Gynecol Oncol Rep       Date:  2020-12-19

8.  Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients.

Authors:  Aaron Gazendam; Anthony Bozzo; Patricia Schneider; Victoria Giglio; David Wilson; Michelle Ghert
Journal:  Trials       Date:  2021-03-20       Impact factor: 2.279

Review 9.  Challenges of international oncology trial collaboration-a call to action.

Authors:  Monica Tang; Heikki Joensuu; Robert J Simes; Timothy J Price; Sonia Yip; Wendy Hague; Katrin M Sjoquist; John Zalcberg
Journal:  Br J Cancer       Date:  2019-08-05       Impact factor: 7.640

10.  Drivers of Start-Up Delays in Global Randomized Clinical Trials.

Authors:  Jennifer Lai; Leila Forney; Daniel L Brinton; Kit N Simpson
Journal:  Ther Innov Regul Sci       Date:  2020-09-21       Impact factor: 1.778

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