The Need for Pragmatic Trials in Genitourinary Oncology

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Background

The European Commission recently had a call for the development of pragmatic trials in the cancer setting. They highlighted the need for more effective and patient-centred interventions, which keep up with the increasing demands in a complex and fragmented oncology healthcare landscape with spiralling healthcare costs. In addition, the impact of the COVID-19 pandemic on cancer care and control has demonstrated the need for different clinical trial designs with fewer inclusion and exclusion criteria that would allow evaluation of real-world effectiveness.

Pragmatic trials are designed to evaluate effectiveness in routine (real-world) clinical practice. The importance and need of these alternative trial designs was also discussed in a recent paper of the European Organisation for Research and Treatment of Cancer. Depending on how they are designed, Randomised Controlled Trials (RCTs) can have the potential to produce strong and actionable Real World Evidence (RWE). The execution of pragmatic trials and studies set up according to the trials-within-cohorts approach can provide valuable answers for some important clinical questions.

As such, this Research Topic aims to focus on the set-up, conduct, and findings of pragmatic trials and trials within cohorts to help improve the management of patients with urological cancers and encourage multidisciplinary approaches for the design of such real world studies. Urological cancers are common, with prostate, bladder and kidney being amongst the 10 most common cancers globally. They affect people of different ages and sexes so that there is a real need for trials that have a direct impact on the implementation of treatments and interventions.

Please note: manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) are out of scope for this section and will not be accepted as part of this Research Topic.

Keywords: genitourinary oncology, cancer, oncology, pragmatic trials, research

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