Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities
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 bee...
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| Published in | The oncologist (Dayton, Ohio) Vol. 24; no. 8; pp. e709 - e719 |
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| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hoboken, USA
John Wiley & Sons, Inc
01.08.2019
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| Subjects | |
| Online Access | Get full text |
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| 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.
Latin American countries have had one of the largest increases in clinical trial participation. This article analyzes the advantages and challenges to conducting precision oncology clinical trials in Latin America. |
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| AbstractList | 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.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. 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. Latin American countries have had one of the largest increases in clinical trial participation. This article analyzes the advantages and challenges to conducting precision oncology clinical trials in Latin America. 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. Latin American countries have had one of the largest increases in clinical trial participation. This article analyzes the advantages and challenges to conducting precision oncology clinical trials in Latin America. |
| Author | Llera, Andrea Sabina Arai, Roberto Jun Soria, Tannia Landaverde, Denis Riechelmann, Rachel P. Lema, Mauricio Montenegro, Paola Muller, Bettina O'Connor, Juan Manoel Guindalini, Rodrigo Santa Cruz Freitas, Helano C. Delgado, Lucía |
| Author_xml | – sequence: 1 givenname: Roberto Jun surname: Arai fullname: Arai, Roberto Jun organization: Núcleo de Pesquisa, Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina da Universidade de São Paulo – sequence: 2 givenname: Rodrigo Santa Cruz surname: Guindalini fullname: Guindalini, Rodrigo Santa Cruz organization: CLION, CAM Group – sequence: 3 givenname: Andrea Sabina surname: Llera fullname: Llera, Andrea Sabina organization: Genocan Laboratory, Fundación Instituto Leloir – CONICET – sequence: 4 givenname: Juan Manoel surname: O'Connor fullname: O'Connor, Juan Manoel organization: Instituto Alexander Fleming – sequence: 5 givenname: Bettina surname: Muller fullname: Muller, Bettina organization: Instituto Nacional del Cancer – sequence: 6 givenname: Mauricio surname: Lema fullname: Lema, Mauricio organization: Clínica de Oncología Astorga – sequence: 7 givenname: Helano C. surname: Freitas fullname: Freitas, Helano C. organization: AC Camargo Cancer Center – sequence: 8 givenname: Tannia surname: Soria fullname: Soria, Tannia organization: Hospital SOLCA – sequence: 9 givenname: Lucía surname: Delgado fullname: Delgado, Lucía organization: Department of Oncology, Hospital de Clínicas, Universidad de la República Oriental del Uruguay – sequence: 10 givenname: Denis surname: Landaverde fullname: Landaverde, Denis organization: Hospital Mexico and Universidad de Costa Rica – sequence: 11 givenname: Paola surname: Montenegro fullname: Montenegro, Paola organization: Instituto Nacional de Enfermedades Neoplasicas – sequence: 12 givenname: Rachel P. surname: Riechelmann fullname: Riechelmann, Rachel P. email: rachel.riechelmann@accamargo.org.br organization: AC Camargo Cancer Center |
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| Keywords | Clinical trials Global oncology Precision oncology Cancer |
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de placebo em pesquisa clínica: proposta de algoritmos decisórios publication-title: Rev Bioética doi: 10.1590/1983-80422015233082 |
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| Snippet | The participation of patients in precision oncology trials needs to fulfill molecular‐based selection criteria. This strongly limits accrual, and as a... The participation of patients in precision oncology trials needs to fulfill molecular-based selection criteria. This strongly limits accrual, and as a... Latin American countries have had one of the largest increases in clinical trial participation. This article analyzes the advantages and challenges to... |
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| SubjectTerms | Cancer Clinical trials Global Health and Cancer Global oncology Precision oncology |
| Title | Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities |
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