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

被引:11
作者
Arai, Roberto Jun [1 ]
Guindalini, Rodrigo Santa Cruz [2 ,3 ]
Llera, Andrea Sabina [4 ]
O'Connor, Juan Manoel [5 ]
Muller, Bettina [6 ]
Lema, Mauricio [7 ]
Freitas, Helano C. [8 ]
Soria, Tannia [9 ]
Delgado, Luca [10 ]
Landaverde, Denis [11 ,12 ]
Montenegro, Paola [13 ]
Riechelman, Rachel P. [8 ]
机构
[1] Univ Sao Paulo, Fac Med, Inst Canc Estado Sao Paulo, Nucleo Pesquisa, Sao Paulo, Brazil
[2] Univ Sao Paulo, Fac Med, Inst Canc Estado Sao Paulo, Ctr Invest Translac Oncol, Sao Paulo, Brazil
[3] CLION, CAM Grp, Salvador, BA, Brazil
[4] Consejo Nacl Invest Cient & Tecn, Fdn Inst Leloir, Genocan Lab, Buenos Aires, DF, Argentina
[5] Inst Alexander Fleming, Buenos Aires, DF, Argentina
[6] Inst Nacl Canc, Santiago, Chile
[7] Clin Oncol Astorga, Medellin, Colombia
[8] AC Camargo Canc Ctr, Sao Paulo, Brazil
[9] Hosp SOLCA, Quito, Ecuador
[10] Univ Republ Oriental Uruguay, Hosp Clin, Dept Oncol, Montevideo, Uruguay
[11] Hosp Mexico, San Jose, Costa Rica
[12] Univ Costa Rica, San Jose, Costa Rica
[13] Inst Nacl Enfermedades Neoplas, Lima, Peru
关键词
Precision oncology; Clinical trials; Global oncology; Cancer; LUNG-CANCER; CONSENT; SOCIETY; ACCESS; HEALTH; STATE;
D O I
10.1634/theoncologist.2018-0318
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:E709 / E719
页数:11
相关论文
共 57 条
[1]  
[Anonymous], 2015, AM J PHARM BENEFITS, V7, pe141
[2]  
[Anonymous], 2017, We Are Social
[3]  
[Anonymous], 2016, FORTUNE
[4]  
Arai RJ, 2009, CLIN CANCER RES, V15, P1121, DOI 10.1158/1078-0432.CCR-08-1824
[5]   Academic health centers: integration of clinical research with healthcare and education. Comments on a workshop [J].
Arai, Roberto Jun ;
Noronha, Irene de Lourdes ;
Nicolau, Jose Carlos ;
Schmidt, Charles ;
de Albuquerque, Gustavo Moreira ;
Mahaffey, Kenneth W. ;
Krieger, Eduardo Moacyr ;
Costa Auler Junior, Jose Otavio .
CLINICS, 2018, 73
[6]  
Arai RJ, 2017, ECANCERMEDICALSCIENC, V11, DOI 10.3332/ecancer.2017.738
[7]   Building research capacity and clinical trials in developing countries [J].
Arai, Roberto Jun ;
Mano, Max Senna ;
de Castro, Gilberto, Jr. ;
Estevez Diz, Maria Del Pilar ;
Gehm Hoff, Paulo Marcelo .
LANCET ONCOLOGY, 2010, 11 (08) :712-713
[8]  
Araujo RLC, 2018, METHODS BIOSTATISTIC
[9]   Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials [J].
Atal, Ignacio ;
Trinquart, Ludovic ;
Porcher, Raphael ;
Ravaud, Philippe .
PLOS ONE, 2015, 10 (12)
[10]  
BAE JM, 2015, EPIDEMIOL HEALTH, V37, DOI DOI 10.4178/EPIH/E2015014