Late-phase oncology trials play a critical role in confirming the safety, efficacy, and broader applicability of cancer treatments. These trials often involve diverse patient populations to ensure the therapeutic benefits and risks of a drug are well understood across varying demographics and disease profiles.
A key focus of late-phase trials is evaluating new treatments for patients whose cancers have progressed or who have not responded to existing therapies. The rise of targeted therapies has revolutionized late-phase oncology research by enabling precision treatment approaches tailored to specific genetic and molecular characteristics of tumors. This has significantly improved outcomes for many patients, highlighting the potential for personalized medicine in oncology.
Moreover, participation in late-phase trials often involves patients enrolling in sequential studies, particularly when earlier interventions prove ineffective or cause adverse effects. This iterative approach underscores the importance of collaboration between patients and healthcare providers in identifying the most effective treatment strategies.
To further advance the field, trends such as decentralized clinical trials and real-world evidence studies are increasingly being integrated into late-phase oncology research. These approaches enhance patient diversity and participation while generating robust data on the long-term efficacy and safety of treatments in everyday clinical settings.
To get a better idea of what Late Phase Oncology research looks like, we will use Citeline, a clinical trial intelligence platform, to outline what the Late Phase Oncology clinical trial landscape looks like today.
To date, there have been over 11,300 Late Phase Oncology trials. Just over 1900 are open and 981 are planned. Here is a breakdown by status.
Late-phase oncology trials encompass both Phase 2-3 and Phase 3 studies, with the latter now being the more prevalent model. This split underscores the prioritization of robust, large-scale data collection needed to support regulatory approvals and establish the therapeutic value of new oncology treatments.
Examining late-phase oncology trials by their start date provides valuable insights into the pipeline of oncology drugs approaching regulatory approval and potential integration into standard care.
These trials, typically in Phase 2/3 or Phase 3, represent treatments that have already undergone rigorous testing for safety, tolerability, and optimal dosing in earlier phases. By the time a drug progresses to late-phase studies, the primary focus shifts from basic safety assessments to a comprehensive evaluation of its efficacy and therapeutic benefit in larger and more diverse patient populations.
Examining planned and ongoing late-phase oncology trials by site location provides valuable insights into global research priorities and the regions driving advancements in cancer treatment. The top 10 site locations for late-phase oncology trials reveal a dynamic and competitive landscape, with China currently leading in the number of ongoing trials, closely followed by the United States.
This notable shift toward China reflects several factors contributing to its growing prominence in oncology research like investment in Healthcare infrastructure and clinical research over the past decade, large and genetically diverse patient population, emergence of Chinese domestic pharmaceutical companies, and regulatory landscape evolution with faster review pathways.
The growing interest in the region also highlights a broader trend in the globalization of clinical trials, emphasizing the need for diverse patient representation to ensure generalizable findings.
| China | 1650 |
| United States | 791 |
| France | 533 |
| Italy | 494 |
| Spain | 478 |
| Germany | 476 |
| United Kingdom | 446 |
| Canada | 429 |
| Japan | 402 |
| South Korea | 388 |
Citeline Trialtrove® – 15NOV2024
At Precision for Medicine, we have worked on over 40 Late Phase Oncology trials.
Precision’s work in late phase oncology follows a similar breakdown as the industry as a whole.
The graph below outlines the Precision’s experience in Late Phase Oncology by Trial Start Dates.
Precision has collaborated with sites in every region where Late Phase Oncology research is actively conducted. The sun doesn’t set on our late phase oncology studies.
Citeline Trialtrove® – 15NOV2024
Precision for Medicine’s Late Phase Oncology experience spans both solid tumors and hematologic trials.
Precision for Medicine has extensive experience in conducting late-phase oncology trials across diverse global regions. Our deep understanding of international regulatory requirements and local patient demographics enables us to navigate complex approval processes and effectively engage with varied populations. With expertise spanning a wide array of therapeutic targets and mechanisms of action, Precision teams effective optimize screening procedures, consistently monitor trial progress, and align closely with your drug development objectives.
Lean how Precision can enhance your upcoming late-phase oncology drug development program.