Abstract
Introduction: To describe the characteristics and trends of clinical trials (CTs) on leukemia registered in the Peruvian Clinical Trial Registry (REPEC, by its Spanish acronym), a descriptive study was conducted on CTs registered between 1995 and July 2024. The REPEC database was searched using the term “leukemia.” Included were CTs involving patients with acute or chronic leukemias, regardless of disease stage or prior treatment. Variables analyzed included type of leukemia, trial phase, type of product, sponsor, international registration, type of outcome, and methodological characteristics. Out of 2,058 CTs identified, 30 (1.5%) were related to leukemia; of these, 70% were chronic and 76% were myeloid. Fifty-seven percent were phase II trials. Fifty percent were sponsored by the pharmaceutical industry, primarily international companies. Eighty percent were open-label studies. Fifty-three percent reported progression-free survival as a surrogate endpoint. In Peru, leukemia clinical trials prioritize chronic forms and early phases, with few clinically relevant outcomes.
| Translated title of the contribution | CARACTERÍSTICAS Y TENDENCIAS DE LOS ENSAYOS CLÍNICOS SOBRE TRATAMIENTOS EN LEUCEMIAS: ANÁLISIS DEL REGISTRO PERUANO DE ENSAYOS CLÍNICOS (1995-2024) |
|---|---|
| Original language | English |
| Journal | Revista de la Facultad de Medicina Humana |
| Volume | 25 |
| Issue number | 1 |
| DOIs | |
| State | Published - 1 Jan 2025 |
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