The Health Policy Partnership, in collaboration with Testbed Sweden for Clinical Trials and Implementation of Precision Health in Cancer Care, has launched a framework to facilitate precision cancer medicine (PCM) clinical trial development. The Implementation Framework for PCM Clinical Trials was created to help researchers design and run trials that prepare health systems to roll out PCM sustainably and equitably.
The framework – a series of questions that cover the preparation, conducting and reporting of clinical trials – was developed with input and guidance from expert advisers.
PCM tailors treatment to a person’s unique biological characteristics. It marks a shift from one-size-fits-all care to care that is personalised at the cellular level. PCM requires health systems to adapt because its individualised nature can mean that there are smaller groups of people who would benefit from a given therapy. This is a challenge for existing clinical, regulatory, health-economic and reimbursement decision-making, which usually rely on evidence generated for large patient populations.
Clinical trials can be used as testbeds for wide-scale implementation, helping prepare a health system to execute PCM at scale. For example, trials can be used to test and increase diagnostic capacity and workforce skill. But for trials to serve this purpose, researchers must design them with the objective of building health system readiness from the start.
The framework was applied to The Swedish Nationwide Clinical Trial to Facilitate Patient Access to Targeted Cancer Treatment based on Biomarker Profiling (FOCU.SE), to show researchers how it could be used. We encourage others to apply it as they being to plan a clinical trial in PCM.
As the PCM landscape evolves, we recognise that this framework will need to be adapted. If you would like to discuss any ideas for its adaptation or application, please contact [email protected].
Read the framework report
For more information, please visit the project page.
