In the US alone, an estimated 1.9 million new cases of cancer were diagnosed in 2022, positioning oncology as a key subject of clinical research. Throughout oncology trial development, it is important that stakeholders acknowledge that only patients can fully understand the impact of treatment on their lives. Regulators are now looking beyond clinical indications such as tumor size and delayed disease progression. When evaluating the risks and benefits of treatment, they want to know whether the side effects are tolerable for patients and how these treatments could be improved from the patient’s perspective. Marrying the scientific rigor of clinical research and the human experience captured by patient-reported outcomes (PROs) is essential to the successful development and evaluation of drugs and treatments.
