(B-088) The evolving landscape of clinical trials in Peru

Background: Clinical research in oncology is important worldwide. The National Institute of Health (NIH) is responsible for regulating studies, however, there has been a recent decline in approved studies.

Objectives: To determine the number of clinical trials submitted to the National Institute of Health (INS) in Peru from 1998 to August 2023, describing their main characteristics as well as the therapies and drugs used in these studies.

Methods: This cross-sectional study examines the clinical trials (CTs) submitted to the NIH in Peru from 1998 to December 2023 (n=2019). The data collected include variables such as medical specialties, pathologies, therapies and Anatomical, Therapeutic and Chemical Classification System. Statistical analysis was performed in R Studio.

Results: The landscape of clinical trials (CTs) in Peru has experienced notable fluctuations over the years, peaking at 150 studies in 2010, followed by a significant decline to just 32 in 2023, of which 93.7% (n=1893) were authorized. In the oncology field, 23.5% (n=474) of the CTs focused on this area, with breast cancer being the most studied pathology at 28.7% (n=136), followed by bronchial and lung cancer at 14.6% (n=69) and prostate cancer at 6.3% (n=30). Regarding clinical trial phases, phase 3 stood out with a high authorization rate of 63.1% (n=299). In terms of funding, oncology CTs were primarily supported by international entities 94.1% (n=446). Moreover, the most frequent sponsors were from the pharmaceutical industry, accounting for 88% (n=417). Among the therapies utilized, targeted therapies are the most frequency with 45.1% (n=214), followed by immunotherapy at 18.4% (n=87) and chemotherapy at 13.9% (n=66). According to the Anatomical Therapeutic Chemical (ATC) Classification System, antineoplastic agents (L01) were the most commonly used, accounting for 78.5% (n=372), followed by endocrine therapies (L02) at 6.8% (n=32), antiemetics (A04) at 3.2% (n=15), and medications for bone diseases (M05) at 3.0% (n=14). Finally, 90.9% (n=431) of oncology CTs in Peru are concentrated in Lima, while only four regions of the country oversee these studies, underscoring the need to diversify research efforts across Peru.

Conclusions: The number of clinical trials in Peru has declined, with oncology standing out as the predominant area, and breast cancer being the most studied pathology. The predominant of targeted therapies, along with immunotherapy and antineoplastic drugs, underscores the need to diversify therapeutic options and foster greater academic involvement while engaging more regions in clinical research.