Patient recruitment for atrial fibrillation clinical trials
Patient recruitment for atrial fibrillation clinical trials
We boost patient recruitment for your atrial fibrillation trial by understanding the patient population and data-driven outreach methods
Atrial fibrillation (AFib) is the most common form of arrhythmia marked by irregular and often accelerated heartbeat. It has a global prevalence of approximately 60 million cases, a rising incidence and causes more than 8 million disability-adjusted life years.
With 18 years’ experience in patient recruitment and managing the recruitment for more than 74 studies in the field of cardiovascular diseases, Clariness is the ideal partner to find the right patients for clinical trials. Our patient-centric approach combined with data-driven digital outreach methods proves to refer more patients to sites while staying under budget.
Overcoming challenges in clinical trial recruitment for atrial fibrillation
Despite progress, atrial fibrillation and ventricular arrhythmias persist, necessitating more research. Challenges like rising costs, complexity, competing priorities, regulatory demands and study implementation issues hinder clinical trial speed.
Clariness has distinct experience with patient recruitment for cardiovascular clinical trials. In one case, a sponsor needed help to rescue a behind-plan study for a Phase III Cardiovascular program, supporting 2 protocols. One protocol had already completed before Clariness joined, and the other had a high screening failure rate due to the unawareness of patients of their LDL-C Value, which led multiple sites to dropping out of the study.
Our approach to rescue the study was:
- Multi-national online awareness campaign employing optimized, country-specific mixes of outreach tactics
- 2-level patient pre-qualification process including online and phone-based pre-screening
- Site support activities, including site helpdesk, was used to optimize efficient use of site resources
Within two months, Clariness provided twice the planned screening patients, with costs 50 % less for screened and randomized patients, leading to an early stop of the campaign, due to achieving the targeted enrollment numbers.
Understanding the patient population
Atrial fibrillation affects approximately 1.0 – 1.5 % of the general population. Most studies show that successful study recruitment requires reaching out to a large number of potential candidates. Moreover, Harrisson et al noted 2018 noted that when patients are not properly informed, they often decide against participation. The most common reason that patients state for not participating in a clinical trial is “no interest” which as Bernice C Yates notes, could also mean reluctance in participation because they do not feel well informed about what participation entails. Thus, it seems crucial to achieve a better patient understanding of clinical trials and to find ways to spark their interest in studies. Ways to drive more patient participation in a clinical trial could include the performance of surveys to understand the patient population’s concerns and reasons for reluctance in study participation. Furthermore, individualized phone screeners pose a chance for patients to address concerns directly and ultimately presenting patient friendly study material of cardiovascular study’s objectives can significantly boost participation rates.
Learn here about how Clariness creates patient friendly study material that is tailored to the needs of each unique clinical trial and drives enrollment.
Our Study Feasibility team consistently assesses recruitment challenges for our key indications, to promptly adapt ongoing and future recruitment campaigns. This evaluation is based on literature reviews and surveys conducted with patients.
Patient Diversity
It’s crucial to have an appropriate representation of diverse patients in a clinical trial to ensure that results can be translated across all patient demographics. For atrial fibrillation trials Sarraju et al noted 2021 an underrepresentation of more than 10 % for Afro Americans and more than 12 % for Hispanic people in the U.S.A. The authors further discerned not just an underrepresentation but also an underreporting of racial / ethnic minority participation. They criticize that such an underreporting limit the ability of gauging generalizability of study results across diverse populations. An underrepresentation of the two groups in atrial fibrillation trials was also asserted by Tertulien et al.
“Focusing on equity is key to ensuring high-quality care for all patients with AF.”
– Tertulien et al.
Steps to improve racial / ethnic inclusion in clinical trials could contain a change in policies and clinical trial regulations to make clinical trials more accessible. Furthermore, hiring more representative members of society across all levels of clinical research could bring more diverse perspectives on an institutional level in clinical trials. Clinical trials organizers would moreover benefit from more engagement with the patient and Health Care Professional community to gain a deeper understanding and gather patient insights. Additionally, to reach minority groups it takes an improved approach of reaching out to patients e.g. through tailored online recruitment campaigns that include accessible info material addressing group-specific concerns. For more information about how to reach more patient inclusivity in a clinical trial you can download our Diversity-Whitepaper.
Enrolling patients aligned with your protocol
In our in-house medical team will review your protocol and align with our patient recruitment team’s objectives and tactics to ensure that patients referred to your research center fit the requirements of your study.
Our medical team then creates the dedicated study and indication pages and pre-screeners, as well as standardizes the script of the telephone screener. The telephone screener confirms that patients who successfully completed the online pre-screener do fulfill the study’s eligibility requirements. This reduces the workload and frustration felt by the study center and the patient. We also provide patient-friendly content that explains clinical trials, regulations, safety measures, and specific processes during the clinical trial. This helps ensure that all patients, across different countries and age ranges, are better informed and less likely to drop out during the trial.
Our digital targeting techniques
We have four ways of targeting patients and caregivers when performing migraine patient recruitment or migraine patient surveys, and continuously review performance to optimize engagement and trial registrations.
Location targeting
We reach atrial fibrillation patients living in areas within a predesignated radius around sites. Depending on the trial protocol, we create a detailed patient profile and matching targeting method.
Interest-based targeting
Patients searching or engaging (e.g., likes, shares, comments, etc.) with atrial fibrillation symptoms or treatments are shown study advertisements. At Clariness, we apply great importance to the representativeness of our advertising. We include images of people from different backgrounds.
Demographic targeting
Based on our patient profile, innovative digital outreach, partnerships and informative content we are able to recruit various groups.
We target group-specific barriers, from lack of trust in clinical science among minorities, to travel distance and understanding of difficulties in participating and health literacy.
Behavioral targeting
We select from over 40+ possible digital channels the most cost-effective option and reach out to our large ClinLife database with a total of 1.3 million users worldwide, based on their location and the trial protocol inclusion and exclusion criteria.
Are you designing an atrial fibrillation clinical trial, or have one underway?
We can help you find the right patients, at the right time. To find out more about our atrial fibrillation patient recruitment, contact us.