From Identification to Enrolment: Pragmatic Trials in Oncology
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There are countless oncology clinical trials running in hospitals all over the word, yet they face persistent challenges with implementation and patient enrolment. Traditional trial designs are often restrictive, resource-intensive, and poorly aligned with real-world clinical practice, limiting accessibility and generalizability for patients to understand what they are signing up for. This is where Pragmatic clinical trials can offer a more flexible, real-world–oriented approach that may improve feasibility and participation. This project aims to evaluate the role of pragmatic trial designs in overcoming multilevel barriers and improving the implementation and impact of oncology clinical trials.
Background
Pragmatic clinical trials have emerged as an alternative to traditional explanatory trial designs, with the potential to enhance the applicability, feasibility, and integration of research within routine clinical practice. In oncology, where clinical trial implementation is often challenged by complex protocols, restrictive eligibility criteria, and significant resource demands, pragmatic approaches may offer a more flexible and real-world–oriented model. However, the extent to which pragmatic trials are being used in oncology, as well as their reported advantages and limitations, remains unclear. Therefore, this scoping review aims to characterize pragmatic clinical trials in oncology by describing their key design features and contexts of use, synthesizing their reported advantages, and identifying the operational, methodological, and institutional challenges associated with their implementation. Additionally, the review will identify gaps in the current literature to inform the development of subsequent physician interviews exploring the feasibility and adoption of pragmatic trial approaches in clinical practice.