Conflito de interesses em ensaios clínicos iniciais envolvendo pacientes com neoplasia de pulmão

Conflict of interests in initial clinical practice involving patients whith lung neoplasia

Conflicto de intereses en ensayos clínicos iniciales involucrando pacientes con neoplasia de pulmón

Resumos

O tratamento padrão para neoplasia de pulmão de não pequenas células (NPNPC) localmente avançada é radioquimioterapia (RQT). Resultados insatisfatórios de sobrevida estimularam estudos iniciais com drogas-alvo. O presente trabalho analisou conflitos de interesse envolvidos em ensaios clínicos fase I/II utilizando-se terapia-alvo + RQT, em pacientes com NPNPC localmente avançada, com base em metanálise apresentada anteriormente. A sobrevida alcançada não demonstrou diferença estatística, comparada ao tratamento-padrão. No entanto, houve aumento da toxicidade. Além disso, 85,7% dos estudos registraram existência de conflitos de interesses. Avaliou-se que o financiamento, pela indústria farmacêutica, está associado a conclusões favoráveis ao tratamento testado. Conforme a DUBDH, benefícios devem ser maximizados e qualquer dano possível, minimizado. E, no entanto, pacientes com enfermidade potencialmente curável, submetendo-se a estudos frequentemente patrocinados pela indústria, apresentaram qualidade de vida diminuída. A conclusão desses estudos, possivelmente influenciada pelos conflitos de interesses dos pesquisadores, está frequentemente distanciada da realidade.

Conflito de interesses; Medição de risco; Pesquisa biomédica-risco

The standard treatment for locally advanced non-small cell lung cancer (NSCLC) is radiochemotherapy (RCT). Unsatisfactory overall survival stimulated initial studies with targeted therapy. This study examined conflicts of interest involved in phase I/II clinical trials using targeted therapy + RQT in patients with NSCLC, based on a previously presented metanalysis. The survival achieved with targeted therapy showed no statistical difference, when compared to standard treatment. However, an increase of toxicities was observed. Besides, 85.7 % of the studies reported conflict of interests. It was found, thus, that the pharmaceutical industry funding is probably associated with favorable results. As shown in the DUBDH, benefits should be maximized and any possible harm, minimized. In this sense, patients with potentially curable disease, undergoing studies (often industry-sponsored), exhibit, though, diminished quality of life. The conclusion of these studies, considered the financial interests of investigators, is often detached from reality.

Conflict of interest; Risk assessment; Biomedical research-risk

El tratamiento estándar para la neoplasia de pulmón de células no pequeñas (NPNPC) localmente avanzada es la radio quimioterapia (RQT). Resultados de supervivencia, todavía, insatisfactoria, han estimulado estudios iniciales con drogas blanco. El presente estudio ha examinado los conflictos de interés que influyen en ensayos clínicos de fase I/II utilizando la terapia blanco + RQT en pacientes con NPNPC localmente avanzada, basada en meta análisis presentada precedentemente. La supervivencia alcanzada no ha resultado en ninguna diferencia estadística si comparada con el tratamiento estándar. Sin embargo, se ha visto un aumento de la toxicidad. Y además, el 85,7% de los estudios han informado la existencia de conflictos de intereses. Se ve, entonces, que la financiación de la industria farmacéutica puede estar asociada con resultados favorables para el tratamiento probado. De acuerdo con la DUBDH, los beneficios deben ser maximizados y los posibles daños deben ser, minimizados. Y entre tanto, los pacientes con enfermedad potencialmente curable, que se someten a estudios a menudo patrocinados por la industria presentaron una disminución de la calidad de vida. La conclusión de estos estudios, posiblemente influenciada por los conflictos de intereses de los investigadores, se aleja, frecuentemente de la realidad.

Conflicto de intereses; Medición de riesgo; Investigación biomédica-riesgo

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Datas de Publicação

• Publicação nesta coleção
  05 Jan 2015
• Data do Fascículo
  Dez 2014

Histórico

• Aceito
  29 Out 2014
• Recebido
  10 Jun 2014
• Revisado
  03 Set 2014