Implementation Framework for Precision Cancer Medicine (PCM) Clinical Trials
Testbed Sweden and Health Policy Network have developed a framework to help researchers design and run trials that support the integration of precision cancer medicine in practice.
Foreword
Over the past two decades, there has been significant progression in the understanding, development and implementation of precision medicine. An increasing number of precisionmedicine initiatives have been launched globally – with many focusing on cancer care.
Precision cancer medicine (PCM) marks a shift from one-size-fits-all care to care that is personalised at the cellular level. With this shift, the way care is delivered changes profoundly, meaning thorough planning is required to ensure that PCM can be equitably and sustainably integrated in practice. Health systems are reacting to the growing demand for this type of care, and new policies and plans are being introduced regularly.
Clinical trials can be used to help prepare a health system to implement PCM at scale – as long as the trials are designed effectively. The Implementation Framework for PCM Clinical Trials has been developed to help researchers design and run trials that ultimately support health systems to implement PCM sustainably and equitably.
The framework is composed of a set of guiding questions that encourage users to systematically evaluate the broader ecosystem in which PCM implementation is to take place. By encouraging users to take a holistic approach, we hope the framework will support them to develop more effective PCM clinical trials, which can act as testbeds to ensure a health system is ready to implement PCM at scale.
This framework will need to be adapted as the PCM landscape evolves. This is the first iteration; we hope that updated versions will follow. Please do reach out to us if you use the framework, or if you would like to suggest updates.
Ebba Hallersjö Hult and Lucy Morgan
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.
What is an implementation framework?
An implementation framework can be an effective tool for understanding what is needed to prepare a health system to adopt new processes or components of care.
A framework facilitates more efficient implementation by providing an overarching view of a health system to ensure potential barriers are identified, monitored and addressed proactively.
Figure 1. Structure of the Implementation Framework for PCM Clinical Trials
How can this framework be used?
The Implementation Framework for PCM Clinical Trials can be used to develop appropriately designed trials that lay the foundations of health system readiness for PCM more broadly. The framework can be used as a roadmap for health system leaders, or can act as a checklist for anyone wanting to set up and run a clinical trial to prepare the wider health ecosystem for PCM.
The framework encompasses the process of setting up, running and reporting on a PCM clinical trial to support overall health system readiness for PCM (Figure 1).
Each section of the framework has subsections that consist of main questions with a drop-down to select current status, and a series of precise questions, known as metrics. These questions aim to guide users to take a holistic approach and think critically about planning, conducting and reporting a trial in a way that prepares the health system for PCM at scale. If there are gaps in the capacity to provide PCM across the health system, the trial can be used as a testbed to build readiness. The framework should be used early in the process of setting up a clinical trial, and can be revisited throughout the trial.
Implementation framework report
Building health system readiness for precision cancer medicine through clinical trials
Editable framework (Word)
Implementation Framework for PCM Clinical Trials
Key partners and stakeholders
Testbed Sweden PHC 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, Co-leader Vision Zero Cancer and Tesybed Sweden PHC
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 Precision Health Cancer for Clinical Trials and Implementation of Precision Health in Cancer Care, an innovation hub financed by the Swedish Innovation Agency and Swelife.