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Building readiness for precision cancer medicine through clinical trials

HPP and Testbed Sweden have developed a framework to help researchers design and run trials that support the integration of precision cancer medicine in practice.

Building readiness for precision cancer medicine through clinical trials

Context

Precision cancer medicine (PCM) enhances the accuracy of cancer care by tailoring treatment based on individual biological markers found in genes, molecules and tissues. It can improve outcomes and quality of life for people with cancer, and minimise side effects by reducing unnecessary treatments.

The widespread availability of PCM is dependent on the integration of advanced technology, robust infrastructure and other necessary resources. Access to PCM varies, with disparities in the availability of diagnostics and treatment across Europe.

Clinical trials can play a pivotal role in preparing health systems for large-scale implementation of PCM. These trials can act as testbeds, assessing everything from data collection platforms to diagnostic capabilities within a country’s health system – allowing the country to prepare for widespread implementation. But for trials to serve this purpose, it is essential that they are designed with the objective of building health system readiness from the very start, ensuring that PCM can be implemented in a way that is both sustainable and equitable.

Project resources

Implementation framework report

Implementation framework report

Building health system readiness for precision cancer medicine through clinical trials: an implementation framework
Building readiness for precision cancer medicine through clinical trials

Editable framework (Word)

Implementation Framework for PCM Clinical Trials

What we’ve achieved

HPP and Testbed Sweden for Clinical Trials and Implementation of Precision Health in Cancer Care (Testbed Sweden) worked with a multidisciplinary group of experts to develop an implementation framework for PCM clinical trials. It aims to support researchers in designing clinical trials that prepare health systems for large-scale PCM implementation.

Consisting of guiding questions and specific metrics that encourage a holistic evaluation of the broader healthcare ecosystem, the new framework builds on HPP’s Readiness Assessment Framework, which was developed based on the World Health Organization’s Pillars for Health System Strengthening. An adaptable version of the framework has been made available in the public domain under a Creative Commons licence, to enable stakeholders anywhere to apply it to their specific context.

The framework has been published as an editable Word document, and an accompanying report details the research behind it and explains how it can be used. As part of the report’s development, HPP worked with experts to apply the framework to the Swedish Nationwide Clinical Trial to Facilitate Patient Access to Targeted Cancer Treatment based on Biomarker Profiling (FOCU.SE), as an example of how the tool can be used. This application is an appendix to the report.

As the landscape of PCM evolves, the framework will be updated. This first iteration invites feedback and collaboration from users to refine and improve future versions.

Key partners and stakeholders

HPP would like to acknowledge and thank the following expert stakeholders for their contribution to this project:

  • Edvard Abel MD/PhD, Head of Sahlgrenska Comprehensive Cancer Centre
  • Daniel Ågren MD/PhD, Personalised Health Care Lead, Roche AB
  • Gunilla Andrew-Nielsen, Health of Clinical Trials, Medical Products Agency
  • Peter Asplund, Director of the Department of Anaesthetic and Intensive Care, Region Örebro Län
  • Annika Baan, MSc Manager, Head of Clinical Trial Unit, Sahlgrenska University Hospital
  • Frida Bayard MD/PhD, Real World Evidence Consultant, IQVIA
  • Anders Edsjö MD/PhD, Vice Director, Genomic Medicine Sweden
  • Elin Fernholm, Policy and Patient Affairs Manager, AstraZeneca
  • Ebba Hallersjö Hult, Project Manager, Stockholm School of Economics Institute for Research
  • Elham Hedayati MD/PhD, Senior Consultant in Clinical Oncology and Coordinator for Clinical Trials, Karolinska University Hospital
  • Annica Juhlin, Medical Advisor, AstraZeneca
  • Christina Kawati Stenberg, Head of Department for Clinical Research and Development, Uppsala University Hospital
  • Professor Kjetil Tasken MD/PhD, Head and Director of Institute for Cancer Research, Oslo University Hospital
  • Frida Nyberg, Oncology Project Manager, Uppsala University Hospital
  • Katarina Nystrom, Lawyer, Genomic Medicine Sweden
  • Bettina Ryll MD/PhD, Affiliated Researcher, Stockholm School of Economics Institute for Research
  • Michel Silvestri MD/PhD, Head of Unit, E-hälsomyndigheten (Swedish eHealth Agency)
  • Jonas Vikman, CEO and Founder, Victri Advice

Project funding

The project was funded by Testbed Sweden for Clinical Trials and Implementation of Precision Health in Cancer Care, an innovation hub financed by the Swedish Innovation Agency and Swelife.

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