Due to market pressures, patient preferences, and trends, the clinical trial industry has been searching for ways to modernise the traditional clinical trial model, streamline processes, and introduce more flexibility and efficiency while yielding high-quality and meaningful results. Although homecare nursing is an excellent example of this forward momentum, clinical research sites may not necessarily perceive it as such. Our team, led by Nicole Bohrmann, looked into the root causes.
Back in September, Nicole Bohrmann, Director of Decentralised Operations, took over the HomeCare Visits (HCV) team. She brings a wealth of experience in clinical trials. Throughout her career, she has shown dedication and leadership, starting as a study nurse and advancing to become a site Director and Territory Director. Prior to joining FutureMeds, she served as a Senior Project Manager, supporting Home Health Care across all continents for a company with 58 locations worldwide.
Under her guidance, our HCV team started to look at how to encourage wider industry adoption of the service.
During a recent workshop in Berlin, they explored the situation and identified one of the blockers: the perception of these solutions. This article aims to share their takeaways.
Why some clinical research sites are reluctant to use home nursing
Some clinical research sites may perceive home nursing as a threat. This can be attributed to various factors:
Concerns About Loss of Control: Sites may worry that integrating home nursing solutions could diminish their control over the clinical trial process, including patient management and data collection.
Fear of Redundancy: There may be a fear that home nursing services could make certain aspects of the site's role redundant, potentially impacting their significance or revenue in the trial.
Misunderstanding of Roles: A lack of clear understanding of the complementary nature of home nursing solutions and the traditional roles of research sites can lead to a perception of competition.
Quality and Compliance Concerns: Sites might be concerned about maintaining the quality of data and adherence to clinical trial protocols when patient interactions and data collection occur outside their direct supervision.
Having evolved our solution over a decade and working closely with site teams, we clearly understand investigator needs, requirements, and wants.
By providing onboarding, support and fine-tuned SOPs, we prioritise establishing a clear foundation for each site, enabling them to remain in control of their performance and understand the benefits our team brings to enhance trial delivery.
How key stakeholders benefit from home nursing
To move toward a better future, Nicole’s team believe that these concerns must be addressed through clear communication, education, and demonstration of the collaborative and supportive nature of home nursing services.
“For more than 10 years, we have been championing patient experience and access to trials through our award-winning service, which is now active in 18 European countries. In order to improve the reach of our solution and help study sites, CROs and Sponsors in the remaining 28 European countries, we plan to grow our portfolio and further improve access to our service.”
- Nicole Bohrmann, Director of Decentralised Operations
Top Patient Benefits:
Minimised Patient Burden: clinical trials with home visit elements reduce the burden on patients and their families by minimising the need for patients to make frequent trips to hospitals or clinics, offering convenience and saving time and effort.
Positive Experience and Trusted Relationships: Patients can build open and trusted relationships with their visiting nurses, enhancing their overall experience and potentially improving retention rates in the trial
Top Site Benefits:
Modernisation and Flexibility: The adoption of homecare nursing represents a step toward a more modern traditional clinical trial model, introducing more flexibility and efficiency while maintaining high-quality outcomes.
Reduced Patient Burden and Higher Recruitment and Retention Rates: By reducing the travel, logistical and personal burden on patients, clinical research sites can see higher recruitment and retention rates. This is especially significant for patients who would otherwise be unable to participate due to access issues.
Broader Enrollment Capabilities: Home nursing reduces the workload on a site team, enabling the enrollment of more participants and running additional trials.
Real-World Data Collection: Home nursing settings can offer insights into how a drug performs in real-world settings, which is valuable for regulatory approvals and market readiness
Top CRO Benefits:
Adapting to Decentralised Trials: The COVID-19 pandemic highlighted the potential impact of decentralised clinical trials, with home healthcare visits playing a pivotal role. This approach aligns with maintaining good clinical practice standards while providing flexibility for patient treatment.
Strategies for Patient-Centric Approaches: Enhancing community engagement, advancing online recruitment, leveraging technologies like wearables, and revising standard operating procedures to accommodate remote and virtual aspects of clinical trials are key strategies that can benefit CROs.
Top Sponsor Benefits:
Enhanced Recruitment Rates: By eliminating the need for regular site visits, more patients, including those who cannot travel or live in remote areas, are likely to participate, enhancing recruitment rates.
Improved Retention Rates and Speedier Market Access: Due to treatment received in everyday settings, in most cases, this can lead to a more accurate understanding of how a drug will be used once it is approved, allowing the drug to potentially reach the marketplace more quickly, benefiting both the patients and the sponsors.
With the growing pressure on the industry to boost trial diversity and improve patient experience, the demand for quality home nursing services like ours is rising.
It is imperative that we, as an industry, decide what future we want to build. We can either move with the evolving needs of patients or remain constrained by the past.
Our solution, HomeCare Visits, has been championing patient experience and trial access in close collaboration with research sites since 2012.
To improve the reach of our solution and help study sites, CROs and Sponsors in the remaining 28 European countries, we plan to grow our portfolio and further improve access to our service.
Specialising in conducting clinical trials, FutureMeds is the 1st European Independent Dedicated DCT Site Network offering high levels of traditional and Decentralized Clinical Trial capabilities across the whole network and home nursing solutions in 18 European countries.
FutureMeds is driven by a purpose to connect a global healthcare community and help bring quicker access to life-changing medications and therapies to all those who need it worldwide.
FutureMeds’ Dedicated Research Site (DRS) teams serve as the company's service foundation. DRS team’s execution capabilities help pharmaceutical companies and contract research organisations accelerate study timelines, streamline processes, lower costs, improve data quality and ultimately help speed up drug development and patient access to new treatments.
FutureMeds @home, the company’s Decentralized Clinical Trial solution, provides pharmaceutical companies, contract research organisations and other partners with powerful insights, tools, teams & support, enabling them to simplify patient access to trials and boost recruitment, engagement and retention.
Through its acquisitions, partnerships and a strategic focus on patient experience, FutureMeds brings opportunities to diverse European patient populations to participate in clinical research under the medical supervision of qualified physicians and health care professionals.
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