Clinical trials are essential to advancing cancer treatment, providing the evidence needed to approve new therapies and improve patient outcomes. However, the strict eligibility criteria used – especially in prostate cancer trials – often exclude real-world patients. These criteria prioritise selecting ‘ideal’ candidates with perfect lab results and few comorbidities, limiting the generalisability of findings. Many trials omit older adults, those with manageable health conditions, previous cancers, or minor lab abnormalities. As a result, the trial populations do not reflect the diversity and complexity of typical patients, leading to outcomes that may overestimate benefit and underestimate risk. For instance, trials like CONTACT-02 and PROPEL used outdated or rarely used treatments, and excluded patients based on prior therapies or specific genomic features without solid scientific justification. This selective approach leaves out key patient groups, including those from lower socioeconomic backgrounds and ethnic minorities, who may have unique pharmacogenomic responses. Studies show fewer than 10% of real-world oncology patients meet trial criteria, and many eligible patients are not even screened. Safety concerns and regulatory standards partly explain these restrictions. Still, with modern advances in cancer care, many patients remain fit for trials even after exhausting standard options. Excluding them limits their treatment choices and deprives research of valuable insights. A shift in trial design is needed – toward adaptive, pragmatic, and post-marketing (phase 4) studies that include broader populations. Regulatory bodies, researchers, and industry stakeholders should promote inclusive strategies that better represent real-world patients. This includes expanding access, relaxing criteria where safe, and involving patients in trial design. Doing so would not compromise scientific rigour but enhance the relevance, equity, and effectiveness of oncology research. Inclusive trials are not only ethical but vital for ensuring that treatments benefit all who need them.
Disconnect between clinical trials and real-world oncology patients
Reviewed by Asif H Ansari
Mind the gap: the disconnect between clinical trials and real-world oncology patients.
