Cancer Trials: Improving Patient Outcomes with PROs

Landmark Guidelines Promise to elevate Patient Voices in Cancer Research

A new framework for standardizing patient-reported outcomes (PROs) in cancer clinical trials, developed by the SISAQOL-IMI consortium and published in The Lancet Oncology on November 25, 2025, is poised to revolutionize how patient experiences inform treatment decisions and healthcare policy. The consortium,co-led by the European Organization for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI),has together released a comprehensive online toolkit to facilitate the widespread adoption of these guidelines.

Did you know? – Patient-reported outcomes (PROs) capture how a patient feels, functioning, and survives with a disease, offering insights beyond traditional clinical measures.

The Critical Need for PRO standardization

For years, capturing the patient outlook – encompassing symptoms, side effects, and overall quality of life – has been a cornerstone of cancer research. However,inconsistencies in methodology have historically hampered the ability to reliably compare data and translate patient insights into tangible improvements in care. “This publication represents a major step forward in how we capture and use patient perspectives in cancer trials,” explained a senior official from the EORTC. “Standardization means that data will be more reliable, comparable, and ultimately more impactful in informing patient care and policy.”

the SISAQOL-IMI initiative represents the culmination of a four-year international collaboration, bringing together academic experts, patient representatives, regulators, health technology assessment bodies, and the pharmaceutical industry. The project’s central goal was to establish consensus-based guidelines for the design, analysis, interpretation, and presentation of PRO data in oncology.

Pro tip: – When designing cancer trials,consider incorporating PROs early in the process to ensure patient experiences are central to research.

A Collaborative Path to Consensus

The development of these recommendations wasn’t a swift process. It involved rigorous systematic reviews, extensive stakeholder consultations, and thorough methodological testing. This collaborative approach, according to a representative from Boehringer Ingelheim, resulted in “a common language for patient-reported outcomes in cancer clinical trials.” They further emphasized that this unified approach will not only bolster the scientific validity of PRO data but also ensure that the patient voice meaningfully influences regulatory and policy decisions globally.

Empowering Implementation with a New Toolkit

To support the practical application of these guidelines, the consortium has launched an accessible online toolkit. this resource provides guidance documents and tools designed for researchers, clinicians, regulators, and policymakers. A key component of the toolkit is a series of plain language checklists, co-produced with patient advocates. “The SISAQOL-IMI plain language checklists offer a co-produced, evidence-informed resource to better support stakeholders…in the design of clinical trial protocols and promote meaningful and consistent interpretation of cancer PRO findings,” stated a leader from Myeloma Patients Europe. Integrating these tools, they believe, will foster greater patient involvement in the development of new oncology trials.

Looking ahead, the SISAQOL-IMI consortium plans to continue expanding its resources, including the development of training materials, all available on the SISAQOL-IMI website. Individuals interested in staying informed are encouraged to follow the EORTC and SISAQOL-IMI on social media.

Reader question: – How might standardized PROs change the way patients participate in their own cancer care? What are your thoughts?

More information can be found in the publication: Cecilie D Amdal et al,SISAQOL-IMI consensus-based guideline