Increasing Inclusiveness of Patient-Centric Clinical Evidence Generation in Oncology: Real-World Data and Clinical Trials.

Abstract

Rapid advancements in cancer discovery, diagnosis, and treatment options available to patients with cancer have highlighted the need for enhancements in clinical trial design. The drug development process is costly, with more than 80% of trials failing to reach recruitment targets. Historical approaches to trial design are increasingly burdensome and lack real-world application in the intent-to-treat patient population. Equitable access to clinical trials combined with increased availability of real-world data are creating new opportunities for inclusiveness, improved outcomes, and evidence-based advances in therapies that will generate more generalizable data to better inform clinical decision-making. Clinical trials need to be inclusive if lifesaving data are not to be missed and investigational therapies are to be more accessible to a broader patient base. Real-world data can facilitate the conduct of studies that are identifying and understanding where disparities exist and developing new interventions to improve patient care. The clinical trial design process should be a multistakeholder and consensus- and evidence-driven process in which stakeholders are working together across the health care industry to close the care gap and ensure elimination of barriers that prevent equal access to specialized cancer care and advanced therapies available in clinical trials. The patient voice is essential throughout the trial process; however, it is often excluded from the design process. Integrating real-world data as well as ensuring patient involvement in early trial design during drug development can enhance enrollment and retention, leading to greater diversity.