TY - JOUR
T1 - CHARACTERISTICS AND TRENDS OF CLINICAL TRIALS ON LEUKEMIA TREATMENTS
T2 - ANALYSIS OF THE PERUVIAN CLINICAL TRIAL REGISTRY (1995–2024)
AU - Cevallos-Alvarado, Hilbert
AU - Espinoza-Yovera, Omar
AU - Munayco-Guillén, Fernando
AU - Bazán-Ruiz, Susy
AU - Pichardo-Rodríguez, Rafael
N1 - Publisher Copyright:
© 2025 Universidad Ricardo Palma, Instituto de Investigaciones en Ciencias Biomedicas, Facultad de Medicina Humana. All rights reserved.
PY - 2025/1/1
Y1 - 2025/1/1
N2 - 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.
AB - 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.
KW - Chronic-phase. (Source: MESH-NLM)
KW - Clinical trial
KW - Leukemia
KW - Leukemia
KW - Leukemia
KW - Myeloid
UR - https://www.scopus.com/pages/publications/105002797083
U2 - 10.25176/RFMH.v25i1.6825
DO - 10.25176/RFMH.v25i1.6825
M3 - Article
AN - SCOPUS:105002797083
SN - 1814-5469
VL - 25
JO - Revista de la Facultad de Medicina Humana
JF - Revista de la Facultad de Medicina Humana
IS - 1
ER -