Respiratory syncytial Virus (RSV)
Need help accelerating your study?
Respiratory syncytial Virus (RSV)
Need help accelerating your study?
We boost patient recruitment for your Respiratory syncytial Virus (RSV) trial by understanding the patient population and data-driven outreach methods
Respiratory Syncytial Virus (RSV) is a respiratory virus causing cold-like symptoms, primarily affecting infants and older adults. While most recover within weeks, RSV can lead to severe cases requiring hospitalization. With an estimated 30 million cases globally each year, RSV is a leading cause of acute respiratory tract infections in young children, contributing to 3.6 million hospital admissions and 100,000 deaths annually.
With 19 years’ experience in patient recruitment and managing the recruitment for more than 60 studies in the field of respiratory diseases, Clariness is the ideal partner to find the right patients for clinical trials.
Overcoming challenges in clinical trial recruitment for ulcerative colitis
A team of researchers conducted a survey in 2017, to investigate recruitment barriers and recruitment strategies for preventive vaccine trials. The scholars noted that patient recruitment for clinical trials poses distinct challenges across demographic groups. While successful strategies exist for trials involving healthy adults and those over 65, hurdles emerge in recruiting pediatric populations, pregnant women, and the very elderly (over 85 years old). The team identified 3 key priorities for improving recruitment in prophylactic vaccine trials: addressing public knowledge gaps on infectious diseases, providing resources for healthcare professionals to engage in clinical trials, and alleviating the burdens on potential volunteers to encourage trial participation.
At Clariness we are aware that reducing the patients’ burden and smoothening their experience during the recruitment process is of great significance. Thus, during the recruitment process, patients can easily self-check their eligibility by filling out a quick pre-screener. Direct phone calls to interested patients are another measure that supports patients and gives them a chance to directly address questions. Furthermore, our Creatives Team creates study material that is tailored to the needs of each unique clinical trial and drives enrollment through patient-friendly informative and educational materials.
Understanding the patient population
In adults and older, healthy children, symptoms of respiratory syncytial virus (RSV) are generally mild and resemble those of the common cold. Most individuals can manage the discomfort with self-care measures. However, RSV can lead to severe infections in certain groups, such as infants aged 12 months and younger, particularly premature infants, older adults, individuals with heart and lung conditions, or those with a weakened immune system (immunocompromised). Moreover, RSV has a greater impact on men compared to women, and the highest mortality rates were observed in regions characterized by a low Social Demographic Index (SDI).
Furthermore, the American Academy of Pediatrics reports that each year, approximately 1% to 3% of children under 12 months old in the United States require hospitalization due to respiratory syncytial virus (RSV). Due to the substantial impact of RSV on the health of infants and young children, there is a great need for treatments for those vulnerable groups.6 This need for treatments collides with the typically slower recruitment rates and limitations in terms of participation that concern clinical trials that include infants, compared to trials involving adults.
Clariness has ample experience with patient recruitment for pediatric clinical trials. In one case Clariness supported a large pharmaceutical company with the recruitment of patients for a Phase IV respiratory disease study including infants and adults. The key challenges were: Recruiting patients in the difficult age group of 4 – 11 years old and coping with physicians who are reluctant to change the effective & tolerated standard of care medication in children. Our approach involved an online recruitment strategy tailored to local demographics and specific target groups for each country. Pre-qualification was conducted online due to the low complexity of the protocol. Additionally, there was a trial site support aimed at enhancing patient outreach capacity. Our recruitment resulted in early enrollment closure for the adult trial and attracted almost 1 million visitors to the pediatric trial website. The total campaign costs were <25% (under budget) and we contributed 36% of adult and 31% of pediatric patients (for the sites we worked together with).
Our study feasibility team gathers data directly from patients and HCPs across the globe and organizes it in our Clinlytics platform. This data-driven service enables users to gain a deeper understanding of the patient population and to conduct more efficient, patient-centric clinical trials.
The first ever vaccine for RSV has been approved for adults ages 60 years and older in 2023.9 However, only view patients aged 80 and above were included in the clinical trial even though this patient group belongs to the most vulnerable patient groups. Other underrepresented groups are patients who are immunocompromised or residing in nursing homes. Studying vaccines in these populations is crucial not only because they are primary recipients of immunizations but also due to the aging immune systems in older adults, which may not mount as robust responses to vaccines as younger immune systems.10 Potential solutions for enhancing participation in clinical trials can be:
- Include modifying study designs to accommodate both adults and children (such as reducing study visits, implementing remote monitoring, and offering flexible hours)
- Providing increased support for knowledge and awareness across all age groups, utilizing digital outreach to connect with family members and caregivers during recruitment
- Implementing retention strategies like visit reminder cards and regular contact
- Emphasizing safety and communicating the benefits of trial participation through study materials
- establishing community-based partnerships, and tackling ageism while fostering trust with medical and clinical staff
If you are interested in gaining a deeper understanding of patient diversity, its relevance for clinical trials, and possible ways to tackle the underrepresentation of different groups of patients, you can download here our diversity whitepaper.
Enrolling patients aligned with your protocol
Our in-house medical team reviews your protocol and aligns 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.
We reach RSV 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.
Patients searching or engaging (e.g., likes, shares, comments, etc.) with RSV 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.
RSV trials face an under-representation of pediatric populations, pregnant women, and the very elderly (over 85 years old). Based on our patient profile, innovative digital outreach, partnerships, and informative content we are able to recruit these 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.
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 a RSV clinical trial, or have one underway?
We can help you find the right patients, at the right time. To find out more about our Sjogren’s syndrome patient recruitment, contact us.