Author: MRN
How can we bring clinical trials into community health systems, increasing patient access to clinical research and reducing patient burden while creating overall more successful trials? Individuals from around the industry with varying backgrounds and experience came together this year at the industry conference Clinical Research As A Care Option (CRAACO) to discuss these questions and work to find answers. As a team, MRN walked away with actions we can take to make this trial model even more sustainable and successful for patients and communities.
Community-based clinical trials describe a trial conducted principally through primary-care physicians, community health centers, and local outpatient facilities rather than at academic research centers. These trials are held to the same standards as those run at academic research centers, including the same regulatory requirements being met, such as Institutional Review Board (IRB) approvals, and having similar study designs.
This model of integrating trials into community health systems presents what seems like obvious benefits. By bringing trials into a patient’s own community, we can:
- Make trial participation easier on patients and their families. Building the infrastructure around the patient can reduce travel and logistical burdens, as well as reducing some financial implications that come with participation, creating more fair opportunities for participation across varying demographics.
- Support more diverse patient populations. We can help patients of varying socio-economic and cultural backgrounds gain access to trials, by bringing the trials closer to them through people they know and trust. This is done by supporting their community healthcare providers and facilities with trial participation.
- Support more physicians and sites to take part in clinical research, supporting drug development overall by bringing new, diverse physicians to the table, fully supported to run trials at their sites, for their patients. This allows patients to participate through physicians they trust at facilities they know.
Building trials into community health systems will help get more patients and more physicians access to clinical research. By bringing trials closer to patients, we can open up research for more diverse and inclusive patient populations, address recruitment and retention challenges for trials, and possibly even shorten the lifecycle of cutting-edge therapeutics – getting drugs to approval and market faster.
However, there are distinct challenges and considerations to this model as well. To ensure success and build a sustainable system that will create more opportunities for more patients to participate in trials, we need to:
- Identify the needs and where the inequalities exist, setting up the right sites, models and solutions to support as many patients as possible.
- Understand what infrastructure is required for the Sponsor to support this design and within the community healthcare facility to support the tasks.
- Incorporate what can make the protocol friendlier and more reflective of how healthcare is actually practiced.
- Campaign and advocate for bringing more research into the real-world care settings, by building relationships with patients in the inpatient setting and engaging bedside providers to bridge the relationships with patients and improve their clinical research knowledge.
- Support the local facility. Facilitate research within health care teams by resolving operational barriers with local practices, training their clinical care teams, and resolving staffing and funding flows required to support these facilities as sustainable, community developments.
When these considerations are met with collaborative solutions from all stakeholders, the benefits are clear; embedding clinical research in the care setting can lead to higher rates of clinical trial participation, produce better health outcomes, lower the cost of care, engage more satisfied patients, and propel an evolved strategy and structure to generate valuable action for the future success of the entire global clinical trial landscape.
MRN’s in-home and at-site solutions are built to address the key challenges of clinical trials, especially patient recruitment and retention. Our mission is to provide a gold standard platform of clinical trial services designed to work together in synergy, bringing trials closer to patients, making trials faster, more efficient, more inclusive and more accessible for all patients and for all research sites around the world.
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