Pragmatic clinical trials can address the diverse needs of patients in the real-world.
Clinical trials are at the heart of medical advancement, but strict controls in their design often mean that only a few people can benefit from new discoveries. When it comes to ovarian cancer, we need to understand and address the diverse needs of real patients – and pragmatic clinical trials could be the key. We’re investing $400,000 in one or more research projects studying a treatment or intervention in a clinical care setting, with an additional $400,000 available for pragmatic clinical trials focused on immune oncology thanks to the generous support of BioCanRx.
Helen MacKay and Alicia Tone lead a discussion at the Pragmatic Clinical Trials Workshop
What Are Pragmatic Clinical Trials?
Unlike traditional explanatory trials which utilize tightly controlled conditions, pragmatic clinical trials prioritize relevance in the real world and have broader eligibility criteria. To achieve this, pragmatic clinical trials:
- Test treatments or interventions using existing infrastructure in real-world healthcare settings to reflect the current reality of cancer care.
- Involve participants from diverse backgrounds, including different ages, races, health status and more, to ensure discoveries apply to as many people as possible.
Pragmatic approaches are essential for developing treatments and care that benefit the greatest number of people – as quickly as possible.
During a recent three-day Fall Forum hosted in collaboration with the Society of Gynecologic Oncology of Canada (GOC), we brought researchers, oncologists, and patients together to discuss the need for research that produces tangible results for real patients – and how pragmatic clinical trials can make this happen.
Five Considerations of Pragmatic Clinical Trials
For researchers looking to develop pragmatic clinical trials, here are five areas to consider that came out from our workshop with researchers, clinicians and patients:
- Focus on practicality: Ensure the trial is easy to implement within the current Canadian healthcare system, minimizing complexity to maximize impact
- Pilot data and feasibility: Include evidence or pilot data to demonstrate the trial’s viability in real-world conditions
- Broad criteria for participation: To ensure a diverse participant group, design eligibility criteria that reflects real patient populations (e.g. age, comorbidities)
- Maximize accessibility: Use a variety of delivery modes (e.g. virtual or hybrid models) to ensure participation is accessible to underrepresented groups
Incorporate patient voices early: Collaborate with patient partners from the start to co-develop trial priorities, protocols, and measurements, rather than only engaging the community once you’ve completed your design (i.e. engagement over buy-in).
Create feedback loops: Gather ongoing patient partner input on trial design, feasibility, and relevance to ensure that your study meets patients’ greatest needs in a meaningful way.
Integrate patient partner feedback: Prioritize outcomes that align with patient-identified values and needs and can create meaningful change in the real-world.
- Strength in numbers: While broader criteria can introduce potentially confounding variables, using thoughtful trial structures can utilize this to enhance practicality and applicability of the trial.
- Measure the true patient experience: Ensure adequate follow-up of participants, including nuanced assessments of quality of life to capture the trial’s true impact beyond traditional measures.
- Pragmatism is a spectrum: Clinical trial elements exist on a spectrum, from explanatory to pragmatic. Identifying which specific elements are pragmatic versus explanatory is crucial when designing pragmatic clinical trials to balance real-world applicability with rigorous scientific evaluation.
- Maintain scientific rigor: Ensuring “apples to apples” comparisons, even in pragmatic trials with multiple variables, is essential to uphold the scientific method and ensure the validity, consistency, and overall impact of trial results.
Funding Call for Researchers
Recognizing the importance of these trials, we launched the Pragmatic Clinical Trials Open Funding Call. Canadian researchers can submit proposals for patient-centred pragmatic clinical trials focused on ovarian cancer by January 31, 2025. We are investing $400,000 and thanks to the generous support of BioCanRx, an additional $400,000 is available for pragmatic clinical trials related to immune oncology.
Video
Meet the OvCAN Patient Partners in Research
Patient Partners discuss their involvement and what it’s like to be at the decision table.
Video
Scientific progress against ovarian cancer
Dr. Stéphanie Lheureux, Clinician Investigator, Princess Margaret Cancer Centre; Dr. Claude Perreault, Principal Investigator, Immunobiology Research Unit, IRIC, Université de Montréal; Dr. Barbara Vanderhyden, Corinne Boyer Chair in Ovarian Cancer Research, University of Ottawa In its third of five years, Ovarian Cancer Canada’s OvCAN initiative is seeing initial results. Hear about scientific models being finalized, new drugs being tested, and clinical trials getting underway. This, as Ovarian Cancer Canada continues to build scientific capacity by expanding tissue banks, providing grants and awards for young scientists, and continuing strategic partnerships. Hope is on the horizon.