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Literature DB >> 25287070

An evaluation of regulatory and commercial barriers to stratified medicine development and adoption.

N A Meadows¹, A Morrison², D A Brindley³, A Schuh⁴, R W Barker⁵.

Abstract

Today, a range of products based on genomics, proteomics and metabolomics have facilitated the development of 'stratified' medicines and companion diagnostics. This investigation profiles a series of targeted medicines and corresponding diagnostics, and their role(s) in supporting evidence-based medicine. Despite their potential benefits we found that scientific, financial and regulatory barriers impede the development and adoption of companion diagnostics. Therefore, in order to realise improvements to the risk/benefit profiles of health-care interventions-notably reducing clinical uncertainty-conferred by the use of companion diagnostics, industry representatives, health-care providers and regulators will need a coordinated response to overcome these barriers.

Mesh：

Year: 2014 PMID： 25287070 DOI： 10.1038/tpj.2014.51

Source DB: PubMed Journal: Pharmacogenomics J ISSN： 1470-269X Impact factor: 3.550

39 in total

1. Vemurafenib in melanoma with BRAF V600E mutation.

Authors: Hiroyuki Morita; Ryozo Nagai
Journal: N Engl J Med Date: 2011-10-13 Impact factor: 91.245

Review 2. Do companion diagnostics make economic sense for drug developers?

Authors: Amit Agarwal
Journal: N Biotechnol Date: 2012-05-01 Impact factor: 5.079

3. Breaking a vicious cycle.

Authors: Daniel F Hayes; Jeff Allen; Carolyn Compton; Gary Gustavsen; Debra G B Leonard; Robert McCormack; Lee Newcomer; Kristin Pothier; David Ransohoff; Richard L Schilsky; Ellen Sigal; Sheila E Taube; Sean R Tunis
Journal: Sci Transl Med Date: 2013-07-31 Impact factor: 17.956

Review 4. Biomarker-based adaptive trials for patients with glioblastoma--lessons from I-SPY 2.

Authors: Brian M Alexander; Patrick Y Wen; Lorenzo Trippa; David A Reardon; Wai-Kwan Alfred Yung; Giovanni Parmigiani; Donald A Berry
Journal: Neuro Oncol Date: 2013-07-14 Impact factor: 12.300

5. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

Authors: Alan G Fraser; Jean-Claude Daubert; Frans Van de Werf; N A Mark Estes; Sidney C Smith; Mitchell W Krucoff; Panos E Vardas; Michel Komajda
Journal: Eur Heart J Date: 2011-05-14 Impact factor: 29.983

Review 6. Adaptive licensing: taking the next step in the evolution of drug approval.

Authors: H-G Eichler; K Oye; L G Baird; E Abadie; J Brown; C L Drum; J Ferguson; S Garner; P Honig; M Hukkelhoven; J C W Lim; R Lim; M M Lumpkin; G Neil; B O'Rourke; E Pezalla; D Shoda; V Seyfert-Margolis; E V Sigal; J Sobotka; D Tan; T F Unger; G Hirsch
Journal: Clin Pharmacol Ther Date: 2012-02-15 Impact factor: 6.875

7. Potential of adaptive clinical trial designs in pharmacogenetic research.

Authors: Frederieke H van der Baan; Mirjam J Knol; Olaf H Klungel; Antoine Cg Egberts; Diederick E Grobbee; Kit C B Roes
Journal: Pharmacogenomics Date: 2012-04 Impact factor: 2.533

8. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer.

Authors: Eric Van Cutsem; Marc Peeters; Salvatore Siena; Yves Humblet; Alain Hendlisz; Bart Neyns; Jean-Luc Canon; Jean-Luc Van Laethem; Joan Maurel; Gary Richardson; Michael Wolf; Rafael G Amado
Journal: J Clin Oncol Date: 2007-05-01 Impact factor: 44.544

Review 9. Genetic association studies to detect adverse drug reactions: abacavir hypersensitivity as an example.

Authors: Arlene R Hughes; Cynthia H Brothers; Michael Mosteller; William R Spreen; Daniel K Burns
Journal: Pharmacogenomics Date: 2009-02 Impact factor: 2.533

10. The sequence of the human genome.

Authors: J C Venter; M D Adams; E W Myers; P W Li; R J Mural; G G Sutton; H O Smith; M Yandell; C A Evans; R A Holt; J D Gocayne; P Amanatides; R M Ballew; D H Huson; J R Wortman; Q Zhang; C D Kodira; X H Zheng; L Chen; M Skupski; G Subramanian; P D Thomas; J Zhang; G L Gabor Miklos; C Nelson; S Broder; A G Clark; J Nadeau; V A McKusick; N Zinder; A J Levine; R J Roberts; M Simon; C Slayman; M Hunkapiller; R Bolanos; A Delcher; I Dew; D Fasulo; M Flanigan; L Florea; A Halpern; S Hannenhalli; S Kravitz; S Levy; C Mobarry; K Reinert; K Remington; J Abu-Threideh; E Beasley; K Biddick; V Bonazzi; R Brandon; M Cargill; I Chandramouliswaran; R Charlab; K Chaturvedi; Z Deng; V Di Francesco; P Dunn; K Eilbeck; C Evangelista; A E Gabrielian; W Gan; W Ge; F Gong; Z Gu; P Guan; T J Heiman; M E Higgins; R R Ji; Z Ke; K A Ketchum; Z Lai; Y Lei; Z Li; J Li; Y Liang; X Lin; F Lu; G V Merkulov; N Milshina; H M Moore; A K Naik; V A Narayan; B Neelam; D Nusskern; D B Rusch; S Salzberg; W Shao; B Shue; J Sun; Z Wang; A Wang; X Wang; J Wang; M Wei; R Wides; C Xiao; C Yan; A Yao; J Ye; M Zhan; W Zhang; H Zhang; Q Zhao; L Zheng; F Zhong; W Zhong; S Zhu; S Zhao; D Gilbert; S Baumhueter; G Spier; C Carter; A Cravchik; T Woodage; F Ali; H An; A Awe; D Baldwin; H Baden; M Barnstead; I Barrow; K Beeson; D Busam; A Carver; A Center; M L Cheng; L Curry; S Danaher; L Davenport; R Desilets; S Dietz; K Dodson; L Doup; S Ferriera; N Garg; A Gluecksmann; B Hart; J Haynes; C Haynes; C Heiner; S Hladun; D Hostin; J Houck; T Howland; C Ibegwam; J Johnson; F Kalush; L Kline; S Koduru; A Love; F Mann; D May; S McCawley; T McIntosh; I McMullen; M Moy; L Moy; B Murphy; K Nelson; C Pfannkoch; E Pratts; V Puri; H Qureshi; M Reardon; R Rodriguez; Y H Rogers; D Romblad; B Ruhfel; R Scott; C Sitter; M Smallwood; E Stewart; R Strong; E Suh; R Thomas; N N Tint; S Tse; C Vech; G Wang; J Wetter; S Williams; M Williams; S Windsor; E Winn-Deen; K Wolfe; J Zaveri; K Zaveri; J F Abril; R Guigó; M J Campbell; K V Sjolander; B Karlak; A Kejariwal; H Mi; B Lazareva; T Hatton; A Narechania; K Diemer; A Muruganujan; N Guo; S Sato; V Bafna; S Istrail; R Lippert; R Schwartz; B Walenz; S Yooseph; D Allen; A Basu; J Baxendale; L Blick; M Caminha; J Carnes-Stine; P Caulk; Y H Chiang; M Coyne; C Dahlke; A Deslattes Mays; M Dombroski; M Donnelly; D Ely; S Esparham; C Fosler; H Gire; S Glanowski; K Glasser; A Glodek; M Gorokhov; K Graham; B Gropman; M Harris; J Heil; S Henderson; J Hoover; D Jennings; C Jordan; J Jordan; J Kasha; L Kagan; C Kraft; A Levitsky; M Lewis; X Liu; J Lopez; D Ma; W Majoros; J McDaniel; S Murphy; M Newman; T Nguyen; N Nguyen; M Nodell; S Pan; J Peck; M Peterson; W Rowe; R Sanders; J Scott; M Simpson; T Smith; A Sprague; T Stockwell; R Turner; E Venter; M Wang; M Wen; D Wu; M Wu; A Xia; A Zandieh; X Zhu
Journal: Science Date: 2001-02-16 Impact factor: 47.728

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