Literature DB >> 22422407

Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031.

Soheil Meshinchi1, Stephen P Hunger, Richard Aplenc, Peter C Adamson, J Milburn Jessup.   

Abstract

The U.S. Food and Drug Administration is now exerting its regulatory authority over the use of molecular diagnostics and related assays for medical decision making in clinical trials, by performing pre-Investigational Device Exemption reviews in all phases of clinical trials. In this review, we assess the analytical performance of the assay for the diagnostic, and consider how that performance affects the diagnostic and the patient and their risks and benefits from treatment. We also discuss the process involved in the first review of a new Children's Oncology Group phase III trial in acute myelogenous leukemia. The lessons learned and recommendations for how to prepare for and incorporate this new level of regulatory review into the protocol development process are presented.

Entities:  

Mesh：

Substances：

Year:  2012        PMID： 22422407      PMCID： PMC3310885          DOI： 10.1158/1078-0432.CCR-11-2205

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  18 in total

1.  Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.

Authors:  J A Wagner; S A Williams; C J Webster
Journal:  Clin Pharmacol Ther       Date:  2007-01       Impact factor: 6.875

2.  Fit-for-purpose method development and validation for successful biomarker measurement.

Authors:  Jean W Lee; Viswanath Devanarayan; Yu Chen Barrett; Russell Weiner; John Allinson; Scott Fountain; Stephen Keller; Ira Weinryb; Marie Green; Larry Duan; James A Rogers; Robert Millham; Peter J O'Brien; Jeff Sailstad; Masood Khan; Chad Ray; John A Wagner
Journal:  Pharm Res       Date:  2006-01-12       Impact factor: 4.200

3.  Development and use of integral assays in clinical trials.

Authors:  Richard L Schilsky; James H Doroshow; Michael Leblanc; Barbara A Conley
Journal:  Clin Cancer Res       Date:  2012-03-15       Impact factor: 12.531

4.  Clinical implications of FLT3 mutations in pediatric AML.

Authors:  Soheil Meshinchi; Todd A Alonzo; Derek L Stirewalt; Michel Zwaan; Martin Zimmerman; Dirk Reinhardt; Gertjan J L Kaspers; Nyla A Heerema; Robert Gerbing; Beverly J Lange; Jerald P Radich
Journal:  Blood       Date:  2006-08-15       Impact factor: 22.113

5.  A comparison of allogeneic bone marrow transplantation, autologous bone marrow transplantation, and aggressive chemotherapy in children with acute myeloid leukemia in remission.

Authors:  W G Woods; S Neudorf; S Gold; J Sanders; J D Buckley; D R Barnard; K Dusenbery; J DeSwarte; D C Arthur; B J Lange; N L Kobrinsky
Journal:  Blood       Date:  2001-01-01       Impact factor: 22.113

6.  Impact of disease risk on efficacy of matched related bone marrow transplantation for pediatric acute myeloid leukemia: the Children's Oncology Group.

Authors:  John T Horan; Todd A Alonzo; Gary H Lyman; Robert B Gerbing; Beverly J Lange; Yaddanapudi Ravindranath; David Becton; Franklin O Smith; William G Woods
Journal:  J Clin Oncol       Date:  2008-10-27       Impact factor: 44.544

7.  Hemorrhagic cystitis after bone marrow transplantation. Risk factors and complications.

Authors:  S F Sencer; R J Haake; D J Weisdorf
Journal:  Transplantation       Date:  1993-10       Impact factor: 4.939

8.  Sorafenib (Nexavar) induces molecular remission and regression of extramedullary disease in a patient with FLT3-ITD+ acute myeloid leukemia.

Authors:  N N Safaian; A Czibere; I Bruns; R Fenk; P Reinecke; A Dienst; R Haas; G Kobbe
Journal:  Leuk Res       Date:  2008-06-24       Impact factor: 3.156

9.  Outcomes in CCG-2961, a children's oncology group phase 3 trial for untreated pediatric acute myeloid leukemia: a report from the children's oncology group.

Authors:  Beverly J Lange; Franklin O Smith; James Feusner; Dorothy R Barnard; Patricia Dinndorf; Stephen Feig; Nyla A Heerema; Carola Arndt; Robert J Arceci; Nita Seibel; Margie Weiman; Kathryn Dusenbery; Kevin Shannon; Sandra Luna-Fineman; Robert B Gerbing; Todd A Alonzo
Journal:  Blood       Date:  2007-11-13       Impact factor: 22.113

10.  Immunophenotypic evidence of leukemia after induction therapy predicts relapse: results from a prospective Children's Cancer Group study of 252 patients with acute myeloid leukemia.

Authors:  Eric L Sievers; Beverly J Lange; Todd A Alonzo; Robert B Gerbing; Irwin D Bernstein; Franklin O Smith; Robert J Arceci; William G Woods; Michael R Loken
Journal:  Blood       Date:  2002-12-27       Impact factor: 22.113
View more
  8 in total

1.  Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development.

Authors:  George Poste; David P Carbone; David R Parkinson; Jaap Verweij; Stephen M Hewitt; J Milburn Jessup
Journal:  Clin Cancer Res       Date:  2012-03-15       Impact factor: 12.531

2.  Impact of preanalytic factors on the design and application of integral biomarkers for directing patient therapy.

Authors:  Stephen M Hewitt; Sunil S Badve; Lawrence D True
Journal:  Clin Cancer Res       Date:  2012-03-15       Impact factor: 12.531

3.  Bridging the gap: moving predictive and prognostic assays from research to clinical use.

Authors:  P Michael Williams; Tracy G Lively; J Milburn Jessup; Barbara A Conley
Journal:  Clin Cancer Res       Date:  2012-03-15       Impact factor: 12.531

4.  Development and use of integral assays in clinical trials.

Authors:  Richard L Schilsky; James H Doroshow; Michael Leblanc; Barbara A Conley
Journal:  Clin Cancer Res       Date:  2012-03-15       Impact factor: 12.531

Review 5.  Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.

Authors:  Lawrence D True
Journal:  Virchows Arch       Date:  2014-02-01       Impact factor: 4.064

6.  Challenges and strategies for identifying biomarkers for colorectal cancer.

Authors:  Bruno Conte; Scott Kopetz
Journal:  Colorectal Cancer       Date:  2013

7.  Analytical Validation and Application of a Targeted Next-Generation Sequencing Mutation-Detection Assay for Use in Treatment Assignment in the NCI-MPACT Trial.

Authors:  Chih-Jian Lih; David J Sims; Robin D Harrington; Eric C Polley; Yingdong Zhao; Michele G Mehaffey; Thomas D Forbes; Biswajit Das; William D Walsh; Vivekananda Datta; Kneshay N Harper; Courtney H Bouk; Lawrence V Rubinstein; Richard M Simon; Barbara A Conley; Alice P Chen; Shivaani Kummar; James H Doroshow; Paul M Williams
Journal:  J Mol Diagn       Date:  2015-11-18       Impact factor: 5.568

8.  Comparing Analytic Methods for Longitudinal GWAS and a Case-Study Evaluating Chemotherapy Course Length in Pediatric AML. A Report from the Children's Oncology Group.

Authors:  Marijana Vujkovic; Richard Aplenc; Todd A Alonzo; Alan S Gamis; Yimei Li
Journal:  Front Genet       Date:  2016-08-05       Impact factor: 4.599
  8 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.