Literature DB >> 24794084

Precision medicine clinical trials: defining new treatment strategies.

Brandy M Heckman-Stoddard, Judith J Smith.   

Abstract

OBJECTIVES: To discuss the role of clinical trials in the changing landscape of cancer care resulting in individualized cancer treatment plans including a discussion of several innovative randomized studies designed to evaluate multiple targeted therapies in molecularly defined subsets of individuals. DATA SOURCES: Medical and nursing literature, research articles, and clinicaltrials.gov.
CONCLUSION: Recent advancements in cancer biomarkers and biomedical technology have begun to transform fundamentals of cancer therapeutics and clinical trials through innovative adaptive trial designs. The goal of these studies is to learn not only if a drug is safe and effective but also how it is best delivered and who will derive the most benefit. IMPLICATIONS FOR NURSING PRACTICE: Implementation of clinical trials in the cancer biomarker era requires knowledge, skills, and expertise related to the use of biomarkers and molecularly defined processes underlying a malignancy, as well as an understanding of associated ethical, legal, and social issues to provide competent, safe, and effective health care and patient communication. Published by Elsevier Inc.

Entities:  

Keywords:  Precision medicine; adaptive design; biomarker; clinical trial; molecular targets; research ethics

Mesh:

Substances:

Year:  2014        PMID: 24794084      PMCID: PMC4280791          DOI: 10.1016/j.soncn.2014.03.004

Source DB:  PubMed          Journal:  Semin Oncol Nurs        ISSN: 0749-2081            Impact factor:   2.315


  18 in total

1.  Adaptive clinical trial design: has its time come?

Authors:  Nancy J Nelson
Journal:  J Natl Cancer Inst       Date:  2010-08-06       Impact factor: 13.506

2.  Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development.

Authors:  Judith Quinlan; Brenda Gaydos; Jeff Maca; Michael Krams
Journal:  Clin Trials       Date:  2010-03-25       Impact factor: 2.486

3.  Adaptive clinical trials: the promise and the caution.

Authors:  Donald A Berry
Journal:  J Clin Oncol       Date:  2010-12-20       Impact factor: 44.544

4.  Oncogenic activity of epidermal growth factor receptor kinase mutant alleles is enhanced by the T790M drug resistance mutation.

Authors:  Nadia Godin-Heymann; Ianthe Bryant; Miguel N Rivera; Lindsey Ulkus; Daphne W Bell; David J Riese; Jeffrey Settleman; Daniel A Haber
Journal:  Cancer Res       Date:  2007-08-01       Impact factor: 12.701

5.  The BATTLE to personalize lung cancer prevention through reverse migration.

Authors:  Kathryn A Gold; Edward S Kim; J Jack Lee; Ignacio I Wistuba; Carol J Farhangfar; Waun Ki Hong
Journal:  Cancer Prev Res (Phila)       Date:  2011-07

6.  Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials.

Authors:  Donald A Berry; Roy S Herbst; Eric H Rubin
Journal:  Clin Cancer Res       Date:  2012-02-01       Impact factor: 12.531

7.  Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma.

Authors:  Tony S Mok; Yi-Long Wu; Sumitra Thongprasert; Chih-Hsin Yang; Da-Tong Chu; Nagahiro Saijo; Patrapim Sunpaweravong; Baohui Han; Benjamin Margono; Yukito Ichinose; Yutaka Nishiwaki; Yuichiro Ohe; Jin-Ji Yang; Busyamas Chewaskulyong; Haiyi Jiang; Emma L Duffield; Claire L Watkins; Alison A Armour; Masahiro Fukuoka
Journal:  N Engl J Med       Date:  2009-08-19       Impact factor: 91.245

8.  Screening for epidermal growth factor receptor mutations in lung cancer.

Authors:  Rafael Rosell; Teresa Moran; Cristina Queralt; Rut Porta; Felipe Cardenal; Carlos Camps; Margarita Majem; Guillermo Lopez-Vivanco; Dolores Isla; Mariano Provencio; Amelia Insa; Bartomeu Massuti; Jose Luis Gonzalez-Larriba; Luis Paz-Ares; Isabel Bover; Rosario Garcia-Campelo; Miguel Angel Moreno; Silvia Catot; Christian Rolfo; Noemi Reguart; Ramon Palmero; José Miguel Sánchez; Roman Bastus; Clara Mayo; Jordi Bertran-Alamillo; Miguel Angel Molina; Jose Javier Sanchez; Miquel Taron
Journal:  N Engl J Med       Date:  2009-08-19       Impact factor: 91.245

9.  Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial.

Authors:  Edward S Kim; Vera Hirsh; Tony Mok; Mark A Socinski; Radj Gervais; Yi-Long Wu; Long-Yun Li; Claire L Watkins; Mark V Sellers; Elizabeth S Lowe; Yan Sun; Mei-Lin Liao; Kell Osterlind; Martin Reck; Alison A Armour; Frances A Shepherd; Scott M Lippman; Jean-Yves Douillard
Journal:  Lancet       Date:  2008-11-22       Impact factor: 79.321

10.  Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial.

Authors:  Jean-Yves Douillard; Frances A Shepherd; Vera Hirsh; Tony Mok; Mark A Socinski; Radj Gervais; Mei-Lin Liao; Helge Bischoff; Martin Reck; Mark V Sellers; Claire L Watkins; Georgina Speake; Alison A Armour; Edward S Kim
Journal:  J Clin Oncol       Date:  2009-12-28       Impact factor: 44.544

View more
  8 in total

Review 1.  The Promise of Nanotechnology in Personalized Medicine.

Authors:  Maha Ali Alghamdi; Antonino N Fallica; Nicola Virzì; Prashant Kesharwani; Valeria Pittalà; Khaled Greish
Journal:  J Pers Med       Date:  2022-04-22

Review 2.  Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Authors:  Miranta Antoniou; Andrea L Jorgensen; Ruwanthi Kolamunnage-Dona
Journal:  PLoS One       Date:  2016-02-24       Impact factor: 3.240

Review 3.  An overview of precision oncology basket and umbrella trials for clinicians.

Authors:  Jay J H Park; Grace Hsu; Ellie G Siden; Kristian Thorlund; Edward J Mills
Journal:  CA Cancer J Clin       Date:  2020-02-07       Impact factor: 508.702

4.  Evaluating the precision of EBF1 SNP x stress interaction association: sex, race, and age differences in a big harmonized data set of 28,026 participants.

Authors:  Abanish Singh; Michael A Babyak; Mario Sims; Solomon K Musani; Beverly H Brummett; Rong Jiang; William E Kraus; Svati H Shah; Ilene C Siegler; Elizabeth R Hauser; Redford B Williams
Journal:  Transl Psychiatry       Date:  2020-10-20       Impact factor: 6.222

5.  Worsened Financial Situation During the COVID-19 Pandemic Was Associated With Depressive Symptomatology Among University Students in Germany: Results of the COVID-19 International Student Well-Being Study.

Authors:  Sarah Negash; Nadja Kartschmit; Rafael T Mikolajczyk; Stefan Watzke; Paula Mayara Matos Fialho; Claudia R Pischke; Heide Busse; Stefanie M Helmer; Christiane Stock; Hajo Zeeb; Claus Wendt; Yasemin Niephaus; Andrea Schmidt-Pokrzywniak
Journal:  Front Psychiatry       Date:  2021-12-16       Impact factor: 4.157

Review 6.  Study designs for clinical trials applied to personalised medicine: a scoping review.

Authors:  Cecilia Superchi; Florie Brion Bouvier; Chiara Gerardi; Montserrat Carmona; Lorena San Miguel; Luis María Sánchez-Gómez; Iñaki Imaz-Iglesia; Paula Garcia; Jacques Demotes; Rita Banzi; Raphaël Porcher
Journal:  BMJ Open       Date:  2022-05-06       Impact factor: 3.006

7.  Supporting precision medicine by data mining across multi-disciplines: an integrative approach for generating comprehensive linkages between single nucleotide variants (SNVs) and drug-binding sites.

Authors:  Amrita Roy Choudhury; Tiejun Cheng; Lon Phan; Stephen H Bryant; Yanli Wang
Journal:  Bioinformatics       Date:  2017-06-01       Impact factor: 6.937

8.  Randomized test-treatment studies with an outlook on adaptive designs.

Authors:  Werner Vach; Antonia Zapf; Amra Hot; Patrick M Bossuyt; Oke Gerke; Simone Wahl
Journal:  BMC Med Res Methodol       Date:  2021-06-01       Impact factor: 4.615

  8 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.