Post-pandemic outlook of the oncology clinical trial landscape.

Abstract

e13549 Background: The oncology clinical trials have grown gradually until 2019. The COVID-19 pandemic led to a marked reduction in clinical trial numbers. To understand the post-pandemic oncology landscape, we analyzed recent clinical trials between 2021 and 2022. Methods: The analytics and insights were obtained from the Kognitic digital platform for 2021 and 2022 (extracted-January 2023). The Kognitic platform applies proprietary Natural Language Processing (NLP) to extract cancer clinical trials from NIH’s clinicaltrials.gov (https://clinicaltrials.gov/ct2/home) and World Health Organization international trials registry ( https://trialsearch.who.int/utn.aspx ). A list of cancer-related synonyms and keywords was used with the NLP algorithm to extract the trials and generate a normalized list which was used for quality check to classify and add to the Kognitic drug database. Results: 14,361 national and international clinical trials launched in 2021 and 2022 were collected and analyzed. Of 14,361 trials, 3906 did not have trial phase information and were excluded from further analysis. We observed a reduction in overall clinical trial numbers in 2022 compared to 2021, with 8000 trials in 2021 and 6361 trials in 2022. In 2021, there were 799 Early Phase trials, 1043 Phase I, 2665 Phase II, 971 Phase III, and 425 Phase IV trials. In 2022, there were 340 Early Phase, 1037 Phase I, 2375 Phase II, 617 Phase III, and 183 Phase IV trials. Of these five Phases, Phase II had the highest number of trials in both 2021 and 2022. Similar to the total number of trials, we observed a general trend of decreasing trial count in all Phases (except Phase I) in 2022 compared to 2021. These trials were distributed across 21 indications, with the highest trial count in gastrointestinal cancer for both years. Out of the total trials, 24.18% of trials in 2021 and 22.93% in 2022 were gastrointestinal cancer trials. Other leading indications were lung cancer, non-Hodgkin lymphoma, breast cancer, and gynecologic cancers. Although the top indications remain the same in 2021 and 2022, there is a general trend of a decreasing number of trials in these indications in 2022. Next, we looked at the targets these trials were focused on. Our results show that Programmed Cell Death Protein 1 (PD-1) was the top target with the highest number of clinical trials, suggesting a continued broadening of the checkpoint inhibitor market. Similar to the total number of trials and the indications, we observed a general trend of decreasing clinical trials in each target in 2022 compared to 2021. Conclusions: Our results show a general trend of decreasing clinical trials in 2022 compared to 2021, suggesting that oncology clinical trials have not resumed pre-pandemic period growth. We observed a reduction in the number of clinical trials collectively and within various categories, namely, trial Phase, indications, and targets.