Literature DB >> 27281466

An Appraisal of Clinically Meaningful Outcomes Guidelines for Oncology Clinical Trials.

Hemanth Kumar1, Tito Fojo2, Sham Mailankody3.   

Abstract

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Year:  2016        PMID： 27281466      PMCID： PMC5632946          DOI： 10.1001/jamaoncol.2016.0931

Source DB:  PubMed          Journal:  JAMA Oncol        ISSN： 2374-2437            Impact factor:   31.777


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  4 in total

1.  Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals.

Authors:  Chul Kim; Vinay Prasad
Journal:  JAMA Intern Med       Date:  2015-12       Impact factor: 21.873

2.  Unintended consequences of expensive cancer therapeutics—the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture.

Authors:  Tito Fojo; Sham Mailankody; Andrew Lo
Journal:  JAMA Otolaryngol Head Neck Surg       Date:  2014-12       Impact factor: 6.223

3.  Five Years of Cancer Drug Approvals: Innovation, Efficacy, and Costs.

Authors:  Sham Mailankody; Vinay Prasad
Journal:  JAMA Oncol       Date:  2015-07       Impact factor: 31.777

4.  American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes.

Authors:  Lee M Ellis; David S Bernstein; Emile E Voest; Jordan D Berlin; Daniel Sargent; Patricia Cortazar; Elizabeth Garrett-Mayer; Roy S Herbst; Rogerio C Lilenbaum; Camelia Sima; Alan P Venook; Mithat Gonen; Richard L Schilsky; Neal J Meropol; Lowell E Schnipper
Journal:  J Clin Oncol       Date:  2014-03-17       Impact factor: 44.544
  4 in total
  13 in total

Review 1.  The high price of anticancer drugs: origins, implications, barriers, solutions.

Authors:  Vinay Prasad; Kevin De Jesús; Sham Mailankody
Journal:  Nat Rev Clin Oncol       Date:  2017-03-14       Impact factor: 66.675

Review 2.  Financial toxicity and implications for cancer care in the era of molecular and immune therapies.

Authors:  George Tran; S Yousuf Zafar
Journal:  Ann Transl Med       Date:  2018-05

Review 3.  Clinical Benefit Scales and Trial Design: Some Statistical Issues.

Authors:  Edward L Korn; Carmen J Allegra; Boris Freidlin
Journal:  J Natl Cancer Inst       Date:  2022-09-09       Impact factor: 11.816

4.  Myosteatosis at diagnosis is adversely associated with 2-year survival in women with estrogen receptor-negative metastatic breast cancer.

Authors:  Patricia Sheean; Sandra Gomez-Perez; Cara Joyce; Paula O'Connor; Monica Bojko; Amber Smith; Vasilios Vasilopoulos; Ruta Rao; Joy Sclamberg; Patricia Robinson
Journal:  Breast Cancer Res Treat       Date:  2021-08-13       Impact factor: 4.624

5.  Clinically meaningful benefit: real world use compared against the American and European guidelines.

Authors:  Jessica J Dreicer; Sham Mailankody; Farhad Fakhrejahani; Vinay Prasad
Journal:  Blood Cancer J       Date:  2017-12-14       Impact factor: 11.037

6.  An Attempt to Quantitate "Value" In Medical Oncologic Therapy.

Authors:  Christie Hancock; Linda Green; Timothy Lestingi; Jacob Bitran Md
Journal:  Cureus       Date:  2018-06-14

7.  Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis.

Authors:  Huseyin Naci; Courtney Davis; Jelena Savović; Julian P T Higgins; Jonathan A C Sterne; Bishal Gyawali; Xochitl Romo-Sandoval; Nicola Handley; Christopher M Booth
Journal:  BMJ       Date:  2019-09-18

8.  Drug development post COVID-19 pandemic: toward a better system to meet current and future global health challenges.

Authors:  Koippallil Gopalakrishnan Aghila Rani; Mohamad A Hamad; Dana M Zaher; Scott McN Sieburth; Navid Madani; Taleb H Al-Tel
Journal:  Expert Opin Drug Discov       Date:  2020-12-28       Impact factor: 6.098

9.  Cost of Oncology Drugs in the Middle-Eastern Country of Lebanon: An Update (2014-2016).

Authors:  Fadia Elias; Ibrahim R Bou-Orm; Salim M Adib; Selim Gebran; Anthony Gebran; Walid Ammar
Journal:  J Glob Oncol       Date:  2018-09

10.  Value Frameworks: Adaptation of Korean Versions of Value Frameworks for Oncology.

Authors:  Green Bae; SeungJin Bae; Donghwan Lee; Juhee Han; Dong-Hoe Koo; Do Yeun Kim; Hee-Jun Kim; Sung Young Oh; Hee Yeon Lee; Jong Hwan Lee; Hye Sook Han; Hyerim Ha; Jin Hyoung Kang
Journal:  Int J Environ Res Public Health       Date:  2021-03-18       Impact factor: 3.390
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