PAtient-driven Cancer Trials (PACT): The development of a patient-centred clinical trial design framework for precision oncology

Redesigning clinical trials to fit the needs and values of cancer patients

A pan-Canadian research team led by Dr. Samantha Pollard (Simon Fraser University) will receive $239,000 over the next year thanks to new funding from the Marathon of Hope Cancer Centres Network’s Patient Voices in Research Initiative. 

The funding will support a new study that will unite patients, caregivers, and healthcare professionals to develop a patient-driven framework for clinical trial design. This new framework is intended to make clinical trials for precision oncology more accessible, align them with patient needs and values, and ensure outcomes that matter most to participants.

By embedding patient and caregiver perspectives, the project seeks to enhance precision medicine research and improve cancer prevention and treatment through inclusive and meaningful clinical trials.

Read our Q&A with the research team to learn more about the project.

How would you describe your project to a lay audience?

Precision oncology – the use of genomic information to guide cancer prevention and treatment - presents an opportunity to improve cancer care. While promising, more evidence is urgently needed to help patients and healthcare providers use genomic information to improve patient length and quality of life. For this to happen, patient participation in clinical trials is necessary. While clinical trials expand treatment options for patients with cancer, participation can be costly, as well as time and energy consuming. In addition, early-stage trials may not generate outcomes that patients consider meaningful. To make clinical trials more accessible to patients while producing valued evidence, a clinical trial design framework developed in collaboration with patients and caregivers is needed. Through the PACT project, alongside patient partners, we will identify and prioritize features of clinical trial designs that align with patient expectations and motivations for participation. This work will help to ensure that the design and conduct of clinical trials for precision oncology directly respond to the needs and preferences of those asked to participate.

What do you hope to achieve by the end of the project?

Through PACT, we will develop and refine a patient-driven clinical trial design framework that directly embeds patient and caregiver perspectives. Firstly, we will qualitatively identify preferences, expectations, anticipated barriers and mitigation strategies for clinical trial participation, from the perspectives of patients and caregivers. We will then co-develop a patient-centred clinical trial design framework to drive future oncology trials. Throughout the research process, we will collaborate with patients, caregivers, clinical trialists, oncologists, and decision makers to ensure feasibility and promote support for the framework.

Why is this project important? How does it advance precision medicine for cancer? What potential impact could it have on patients?

Precision medicine can only advance meaningfully if the outcomes generated are beneficial to patients. To generate data, evidence and effective therapies, patient participation in clinical trials is necessary. Though PACT, our work will endeavour to ensure that clinical trials are designed in a way that is more accessible to patients, measure outcomes that are valuable to patients, and are subsequently equipped enhance cancer prevention and treatment innovation.

This funding opportunity was designed and adjudicated by members of the Network’s Patient Working Group, who are all cancer patients and survivors or caregivers and family members. Why do you think it’s important for the Network to fund this type of patient-centric research? Have you ever encountered a funding opportunity like this before?

Clinical, early-stage data generation has so often been designed with data in mind, but not the patients who contribute their information to make innovation possible. Alongside the emergence of genomics, now more than ever, patient participation in research is critical to the development and evaluation of prevention and treatment strategies. If, as researchers, we seek to design studies and recruit patient participants to help us generate meaningful evidence, we first need to better understand how to conduct research in a manner that is acceptable, appropriate, and valued by those asked to participate.

This funding opportunity offers us an opportunity to directly acknowledge and address limitations to current clinical trial design, and to ensure that future trials place patient preferences, abilities, and expectations at their forefront. As PI of this work, I am grateful to the Patient Working Group and the MOHCCN for dedicating funding so that clinical innovation can progress alongside patient and caregiver informed evidence generation, as a necessary adjunct.