Literature DB >> 33811119

The Future of Clinical Trial Design in Oncology.

Anna Spreafico1,2, Aaron R Hansen1,2, Albiruni R Abdul Razak1,2, Philippe L Bedard1,2, Lillian L Siu3,2.   

Abstract

Clinical trials represent a fulcrum for oncology drug discovery and development to bring safe and effective medicines to patients in a timely manner. Clinical trials have shifted from traditional studies evaluating cytotoxic chemotherapy in largely histology-based populations to become adaptively designed and biomarker-driven evaluations of molecularly targeted agents and immune therapies in selected patient subsets. This review will discuss the scientific, methodological, practical, and patient-focused considerations to transform clinical trials. A call to action is proposed to establish the framework for next-generation clinical trials that strikes an optimal balance of operational efficiency, scientific impact, and value to patients. SIGNIFICANCE: The future of cancer clinical trials requires a framework that can efficiently transform scientific discoveries to clinical utility through applications of innovative technologies and dynamic design methodologies. Next-generation clinical trials will offer individualized strategies which ultimately contribute to globalized knowledge and collective learning, through the joint efforts of all key stakeholders including investigators and patients. ©2021 American Association for Cancer Research.

Entities:  

Mesh:

Year:  2021        PMID: 33811119      PMCID: PMC8099154          DOI: 10.1158/2159-8290.CD-20-1301

Source DB:  PubMed          Journal:  Cancer Discov        ISSN: 2159-8274            Impact factor:   38.272


  61 in total

Review 1.  Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study.

Authors:  Vineeta Agarwala; Sean Khozin; Gaurav Singal; Claire O'Connell; Deborah Kuk; Gerald Li; Anala Gossai; Vincent Miller; Amy P Abernethy
Journal:  Health Aff (Millwood)       Date:  2018-05       Impact factor: 6.301

Review 2.  Accelerated approval of oncology products: the food and drug administration experience.

Authors:  John R Johnson; Yang-Min Ning; Ann Farrell; Robert Justice; Patricia Keegan; Richard Pazdur
Journal:  J Natl Cancer Inst       Date:  2011-03-21       Impact factor: 13.506

3.  Clinical trial design for rare cancers: why a less conventional route may be required.

Authors:  Katherine S Panageas
Journal:  Expert Rev Clin Pharmacol       Date:  2015       Impact factor: 5.045

4.  Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer.

Authors:  Scott Kopetz; Axel Grothey; Rona Yaeger; Eric Van Cutsem; Jayesh Desai; Takayuki Yoshino; Harpreet Wasan; Fortunato Ciardiello; Fotios Loupakis; Yong Sang Hong; Neeltje Steeghs; Tormod K Guren; Hendrik-Tobias Arkenau; Pilar Garcia-Alfonso; Per Pfeiffer; Sergey Orlov; Sara Lonardi; Elena Elez; Tae-Won Kim; Jan H M Schellens; Christina Guo; Asha Krishnan; Jeroen Dekervel; Van Morris; Aitana Calvo Ferrandiz; L S Tarpgaard; Michael Braun; Ashwin Gollerkeri; Christopher Keir; Kati Maharry; Michael Pickard; Janna Christy-Bittel; Lisa Anderson; Victor Sandor; Josep Tabernero
Journal:  N Engl J Med       Date:  2019-09-30       Impact factor: 91.245

5.  Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1.

Authors:  Stéphane Champiat; Laurent Dercle; Samy Ammari; Christophe Massard; Antoine Hollebecque; Sophie Postel-Vinay; Nathalie Chaput; Alexander Eggermont; Aurélien Marabelle; Jean-Charles Soria; Charles Ferté
Journal:  Clin Cancer Res       Date:  2016-11-08       Impact factor: 12.531

Review 6.  International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.

Authors:  Corneel Coens; Madeline Pe; Amylou C Dueck; Jeff Sloan; Ethan Basch; Melanie Calvert; Alicyn Campbell; Charles Cleeland; Kim Cocks; Laurence Collette; Nancy Devlin; Lien Dorme; Hans-Henning Flechtner; Carolyn Gotay; Ingolf Griebsch; Mogens Groenvold; Madeleine King; Paul G Kluetz; Michael Koller; Daniel C Malone; Francesca Martinelli; Sandra A Mitchell; Jammbe Z Musoro; Daniel O'Connor; Kathy Oliver; Elisabeth Piault-Louis; Martine Piccart; Chantal Quinten; Jaap C Reijneveld; Christoph Schürmann; Ashley Wilder Smith; Katherine M Soltys; Martin J B Taphoorn; Galina Velikova; Andrew Bottomley
Journal:  Lancet Oncol       Date:  2020-02       Impact factor: 41.316

Review 7.  A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Authors:  Julia A Beaver; Lynn J Howie; Lorraine Pelosof; Tamy Kim; Jinzhong Liu; Kirsten B Goldberg; Rajeshwari Sridhara; Gideon M Blumenthal; Ann T Farrell; Patricia Keegan; Richard Pazdur; Paul G Kluetz
Journal:  JAMA Oncol       Date:  2018-06-01       Impact factor: 31.777

8.  A reality check of the accelerated approval of immune-checkpoint inhibitors.

Authors:  Jennifer Gill; Vinay Prasad
Journal:  Nat Rev Clin Oncol       Date:  2019-08-05       Impact factor: 66.675

9.  Increasing minority participation in cancer clinical trials: the minority-based community clinical oncology program experience.

Authors:  Worta McCaskill-Stevens; Martha M McKinney; Cynthia G Whitman; Lori M Minasian
Journal:  J Clin Oncol       Date:  2005-08-01       Impact factor: 44.544

10.  How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials.

Authors:  Warren B Sateren; Edward L Trimble; Jeffrey Abrams; Otis Brawley; Nancy Breen; Leslie Ford; Mary McCabe; Richard Kaplan; Malcolm Smith; Richard Ungerleider; Michaele C Christian
Journal:  J Clin Oncol       Date:  2002-04-15       Impact factor: 44.544

View more
  3 in total

Review 1.  Toward personalized treatment approaches for non-small-cell lung cancer.

Authors:  Meina Wang; Roy S Herbst; Chris Boshoff
Journal:  Nat Med       Date:  2021-08-12       Impact factor: 87.241

Review 2.  Anti-Angiogenic Therapy in ALK Rearranged Non-Small Cell Lung Cancer (NSCLC).

Authors:  Aaron C Tan; Nick Pavlakis
Journal:  Int J Mol Sci       Date:  2022-08-09       Impact factor: 6.208

Review 3.  Clinical Trial Eligibility Criteria and Recently Approved Cancer Therapies for Patients With Brain Metastases.

Authors:  Aaron C Tan; Drexell H Boggs; Eudocia Q Lee; Michelle M Kim; Minesh P Mehta; Mustafa Khasraw
Journal:  Front Oncol       Date:  2022-01-03       Impact factor: 6.244

  3 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.