Maximizing patient recruitment for rhinosinusitis trials in a competitive market
The patient and economic impact of rhinosinusitis
It is estimated that between 5-12% of the global population suffers from chronic rhinosinusitis, with a prevalence of 12.3% in the United States, 10.9% in Europe, and 13% in China. The exact incidence and prevalence of chronic rhinosinusitis varies depending on several factors, including but not limited to age, sex, genetics, environmental exposure, and other underlying health conditions.
Chronic rhinosinusitis (CRS) impacts both the patient’s quality of life and the global economy. For patients, the symptoms of nasal congestion, facial pain, headaches, and fatigue, impact the quality of their lives and often leads to decreased productivity, and enjoyment of life. As CRS accounts for >50% of patients with rhinosinusitis, these prolonged symptoms and decreased productivity greatly impact the economy. In the United States, the direct cost of CRS on healthcare systems is estimated between $10-13 billion, and the indirect cost of CRS, due to missed workdays, absenteeism, and productivity loss, is estimated to exceed $20 billion per year.
Growing competition for patients with rhinosinusitis
The high prevalence of rhinosinusitis and its impact on the global economy has led to a growing number of rhinosinusitis clinical trials. At the time of writing this blog, there are more than 140 rhinosinusitis studies planned or recruiting patients, which accounts for more than half of the total number of rhinosinusitis studies completed over the last 25 years. Below you can see the growing amount of rhinosinusitis clinical trials started every 5 years since 2000, with a projection for 2020-2025.
How to reach enrollment targets despite this competition
In a recent chronic rhinosinusitis patient recruitment campaign, Clariness was able to deliver +145% registrations, +216% referrals, and +220% consented patients, despite 40% of our activated sites having competing studies.
This blog explores how you can reach your enrollment goals despite this growing number of rhinosinusitis trials, through:
- Using feasibility to better understand your target population
- Leveraging highly targeted digital outreach campaigns & pre-screeners
- Supporting sites throughout the referral to randomization journey
- Working with an experienced patient recruitment partner like Clariness
How patient and HCP feasibility can support your rhinosinusitis patient recruitment
The importance of feasibility
At Clariness, we’ve seen a growing level of study protocol complexity in recent years, and while there’s a high global prevalence of CRS, it is important to ensure your study is designed to reach your target population.
Through our access to more than 15M patients and 7,000+ sites across the globe, we survey both patients and HCPs to better understand which locations and sites will be best suited to the exacting patient population of our client’s protocols. This is important as site selection directly impacts the available patients for your clinical trial.
Factors such as location, access to medical facilities, and local demographics can influence patient eligibility and willingness to participate in a study. By choosing sites that align with your protocol, you’ll be more likely to reach sufficient patient enrollment numbers that match your diverse I/E criteria.
How site selection can alleviate site burden
The growing number of rhinosinusitis trials means more sites are recruiting similar patients, in our most recent rhinosinusitis patient recruitment campaign, 40% of our activated sites had competing studies, and we expect this to be higher in more populated areas.
It’s reported that:
- 66% of sites fail to meet their original enrollment targets
- 37% of sites don’t meet adjusted enrollment targets
- 50% of sites will recruit just 1 patient
Patient and site feasibility can ensure you choose the right sites for your rhinosinusitis patient recruitment campaigns, knowing the local population meets your I/E requirements, and that your sites can handle high numbers of patient referrals and efficiently randomize them.
How highly targeted rhinosinusitis patient recruitment campaigns and pre-screeners
Tailor your channels, and campaign materials, to your population
At Clariness, we have 18+ years’ of experience in online patient recruitment and have performance data across every channel, indication, and site we’ve ever worked with. We combine this with our in-house medical analysis of your protocol to create a chronic rhinosinusitis patient recruitment campaign that is specifically aligned with your target patient population.
However, generating great awareness, and high volumes of referrals, does not guarantee you’ll reach your rhinosinusitis patient enrollment targets. Referrals need to be of high quality, pre-qualified and managed in a timely, and efficient manner by your sites.
Our patient recruitment journey consists of these core steps to ensure success:
- Identify the target population
Using our patient database, historic performance data, medical analysis and direct-to-patient surveys, we identify your target population, create a suitable channel strategy, and patient-friendly materials.
- Patient outreach and engagement
We digitally deploy our rhinosinusitis patient recruitment campaigns and monitor the performance ongoingly. This allows us to optimize the media budget spend in real-time to the highest performing channels and ad materials, to generate the best patient acquisition cost possible.
- Online and phone screening
Once a patient engages with our materials, they are directed to a study landing page, in their local language, and accompanied by patient content like FAQs, reading materials, and more to begin the registration process. During this, we digitally pre-screen patients to immediately pre-qualify patients at the time of registering for your study. Further, our medical-trained agents call patients to ask deeper-level questions about their symptoms, discuss any questions or concerns they have, and directly schedule their appointments with participating sites.
- Referral management
Simply referring patients to sites, even pre-qualified patients, does not guarantee successful randomization of all site referrals. At Clariness, we have a dedicated Enrollment Success Team, that act as a liaison between both patients and site staff, directly scheduling site visits, and supporting site staff through the entire referral to randomization journey. As a result, we’ve seen much higher randomization rates of our own referrals, and indirectly, of the site’s own patient database, as we keep your study top of mind for HCPs, which gives you a competitive edge over similar studies.
Support sites throughout the referral to randomization journey
Site burden in clinical trials is incredibly persistent, and it is only worsened when trials are searching for higher numbers of patients, and sites are supporting competing studies.
At Clariness, we have a few tactics to overcome these burdens with regard to rhinosinusitis patient recruitment, these are:
- Streamline study processes: Simplify your rhinosinusitis study protocol and procedures to minimize the amount of time and resources required at the site level. You can discover the trade-off between protocol requirements and patient willingness to participate through feasibility surveys to find your optimum requirements to retention ratio.
- Provide training and support: We offer training on our referral management platform, and ongoing support to study staff, to help them understand and comply with study protocols and procedures and efficiently screen and randomize your patients. We also work to understand the workload levels of the sites we’re working with, and will temporarily pause overburdened sites in our digital referral process to manage bottlenecks actively throughout the campaign lifecycle.
- Enhance patient engagement: Develop patient-centered strategies to increase patient engagement and retention, such as remote monitoring, patient-friendly consent forms, and clear communication of study goals and expectations. Further, Clariness offers creative services to design patient materials that unlock the full potential of your sites. Providing site staff with all the materials they need to inform a patient has a huge impact on which rhinosinusitis study they promote to match patients.
- Patient-centric approach: We can translate patient-facing materials to appeal to diverse patient populations within a specific country.
- Foster collaboration: Establish strong relationships and partnerships between yourself and sites, and other stakeholders, to ensure that all parties are aligned and working towards a common goal.
- Continuously evaluate and improve: Continuously evaluate site performance, through online, real-time analytics like those provided by Clariness through our sponsor portal.
Implementing these strategies can help reduce site burden and improve the efficiency, feasibility, and overall success of your chronic rhinosinusitis clinical trial.
Working with an experienced patient recruitment partner like Clariness
All of the aforementioned tips can be implemented by any sponsor, however, they can take a huge amount of time and resources to establish if there are no underlying foundations, including a strong user-driven study registration journey, site networks to perform better site selection, and access to millions of patients to get patient-reported data for better study design.
Collaborating with a patient recruitment partner such as Clariness, allows trial organizers and sites to immediately access the wealth of data, sites, and patients we have amassed over the last 18 years. See below a case study from a recent rhinosinusitis patient recruitment campaign, which leverages everything mentioned in this blog to even double the number of consented patients vs. initially projected numbers.
Case study: How we consented +220% of patients with rhinosinusitis
Overview
A US-based clinical-stage company was looking to boost referrals of participants with chronic rhinosinusitis. Partnering with participating sites throughout the referral to randomization process, leveraging 40+ digital channels, and our patient database, we over-delivered referrals, increased site efficiency, and ultimately double the consented number of patients.
Key challenges
- EC document approval took longer than expected for approval, reducing our actionable timeline for rhinosinusitis patient recruitment
- We promoted two similar studies, with differing protocols for the sponsor
- Encountered multiple site-specific challenges:
- Half the planned number of sites were activated
- 40% had competing studies underway
- Many had never worked with a recruitment vendor
Overcoming these barriers
- EC document approval timelines: Leveraging indication-specific campaigns while waiting for approval on study-specific materials, we were able to maximize the number of site participation with Clariness services. This approach ensures a greater selection of sites for the chronic rhinosinusitis patient population.
- Site-specific challenges:
- Our Enrollment Success Team directly scheduled the visits of patients, to ensure they were seen ahead of competitive referrals
- On average, we trained and activated fewer sites, within a period of two weeks, thereby allowing us to commence referring patients at the earliest opportunity and meet the sponsor’s timeline.
- Our team, and platform, made it very easy and simple for site staff to manage and update referrals, and they were very pleased to have pre-qualified patients with core information available at the time of scheduling the visit
Key results
Our digital marketing and Enrollment Success Teams worked with patients and sites to overperform at every step of the patient recruitment funnel vs. our initial projections:
- +145% study registrations
- +216% referrals
- +220% consented patients
Want to know how we can support your rhinosinusitis patient recruitment?
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