Literature DB >> 30910864

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities.

Roberto Jun Arai1, Rodrigo Santa Cruz Guindalini2,3, Andrea Sabina Llera4, Juan Manoel O'Connor5, Bettina Muller6, Mauricio Lema7, Helano C Freitas8, Tannia Soria9, Lucía Delgado10, Denis Landaverde11, Paola Montenegro12, Rachel P Riechelmann13.   

Abstract

The participation of patients in precision oncology trials needs to fulfill molecular-based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high-tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower-middle- and low-income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. IMPLICATIONS FOR PRACTICE: Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer. © AlphaMed Press 2019.

Entities:  

Keywords:  Cancer; Clinical trials; Global oncology; Precision oncology

Year:  2019        PMID: 30910864      PMCID: PMC6693712          DOI: 10.1634/theoncologist.2018-0318

Source DB:  PubMed          Journal:  Oncologist        ISSN: 1083-7159


  38 in total

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Journal:  Sci Transl Med       Date:  2015-12-23       Impact factor: 17.956

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Journal:  Nat Med       Date:  1998-01       Impact factor: 53.440

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5.  GINA, genetic discrimination, and genomic medicine.

Authors:  Robert C Green; Denise Lautenbach; Amy L McGuire
Journal:  N Engl J Med       Date:  2015-01-29       Impact factor: 91.245

6.  Current challenges in handling genetic data.

Authors:  Patricia R Blank; Felix Gutzwiller
Journal:  Swiss Med Wkly       Date:  2014-08-21       Impact factor: 2.193

Review 7.  Improvement of informed consent and the quality of consent documents.

Authors:  Michael Jefford; Rosemary Moore
Journal:  Lancet Oncol       Date:  2008-05       Impact factor: 41.316

Review 8.  Big data analytics in healthcare: promise and potential.

Authors:  Wullianallur Raghupathi; Viju Raghupathi
Journal:  Health Inf Sci Syst       Date:  2014-02-07

9.  Clinical research in Brazil.

Authors:  Luiz Vicente Rizzo; Luis Fernando Aranha Camargo
Journal:  Einstein (Sao Paulo)       Date:  2013 Jan-Mar

10.  The Judicialization of Health and the Quest for State Accountability: Evidence from 1,262 Lawsuits for Access to Medicines in Southern Brazil.

Authors:  João Biehl; Mariana P Socal; Joseph J Amon
Journal:  Health Hum Rights       Date:  2016-06
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  2 in total

1.  Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420).

Authors:  Aline B Lara Gongora; Gustavo Werutsky; Denis L Jardim; Angelica Nogueira-Rodrigues; Carlos H Barrios; Clarissa Mathias; Fernando Maluf; Rachel Riechelmann; Maurício Fraga; Henry Gomes; William N William; Camilla A F Yamada; Gilberto de Castro; Daniela D Rosa; Andreia C de Melo; Raul Sala; Eva Bustamante; Denisse Bretel; Oscar Arrieta; Andrés F Cardona; Diogo A Bastos
Journal:  JCO Glob Oncol       Date:  2021-04

2.  Vitamin D Supplementation Does Not Impact Resting Metabolic Rate, Body Composition and Strength in Vitamin D Sufficient Physically Active Adults.

Authors:  Karina Romeu Montenegro; Vinicius Cruzat; Hilton Melder; Angela Jacques; Philip Newsholme; Kagan J Ducker
Journal:  Nutrients       Date:  2020-10-12       Impact factor: 5.717

  2 in total

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