Facilitating the first site visit for potential participants in clinical studies presents several challenges that can impact the study's success. One of the primary issues is logistical coordination, where participants may face difficulties in scheduling, transportation, or understanding the importance of the visit, leading to delays or cancellations. Additionally, there may be apprehensions or misunderstandings about the study’s procedures, causing participants to hesitate or withdraw from the study. Communication barriers, especially with participants from diverse backgrounds or those with specific health conditions, can further complicate this process. These challenges underscore the need for a comprehensive support system, clear communication strategies, and tailored approaches to ensure participants are well-informed, comfortable, and able to attend their first site visit as planned.
One way to increase the success of participants' first site visit is to engage with them before their arrival through online pre-screeners and phone calls that can pre-qualify their eligibility and help aid their understanding of the study.
An online pre-screener can play a crucial role in enhancing studies, particularly in ensuring that participants are well-prepared and likely to attend their first site visit. By engaging participants early in the process, pre-screening can help to identify those who are genuinely interested and qualified for the study. This customizable tool filters potential participants at the top of the funnel and facilitates the recruitment process for those interested.
This proactive approach can also allow for the initiation of medical record collection, a vital step that typically begins during the first site visit and can last for weeks. However, by starting this process earlier on a phone screen, sites can streamline the initial visit and reduce the time required for record gathering, making the visit more efficient for both the participants and the research team.
Pre-screeners and phone screens also set the stage for a smoother and more organized first site visit, which typically lasts 2-4 hours, depending on the complexity of the study. This online pre-screening phase relies on participants engagement with the study website, signaling their active interest in the research. Also, speaking with a real person during this phase further increases potential participants’ confidence in the process, providing them with a platform to ask questions and clarify any concerns they may have about the study. This personal interaction not only reassures participants but fosters a sense of trust and commitment, which is essential for their continued involvement in the study.
Incorporating pre-screeners directly into your study website is an effective way to filter potential participants based on high-level eligibility criteria. These questions should be designed to be broad enough to avoid excluding any potential participants, yet informative enough to align with the study's inclusion and exclusion criteria.
With a well-crafted pre-screener in place, interested individuals can express their interest directly on your website. To maintain their engagement, it is crucial to reach out as soon as possible for a more comprehensive pre-qualification phone screen.
Phone screens offer a valuable opportunity to delve deeper into the patient’s interest in the study, assess their eligibility against the inclusion/exclusion criteria, and address any questions they may have about the clinical research process. For example, we often have potential participants share additional information about their condition or about their medication, giving us a firsthand experience of barriers and needs faced in the community. This information is taken back to the sponsor to make data-driven decisions on their study specific recruitment strategy. This human interaction at an early-stage fosters trust in the research process, providing participants with a personal point of contact throughout their journey, which in turn boosts their confidence and engagement in the study.
No one answers phone calls these days, why integrate phone screens into my strategy?
Just as with site visits, participants are more likely to take a phone screen call if they have the flexibility to choose a time and date that works for them—especially if they’ve already shown interest in the study. Building trust and clear communication from the start, through reminders like text messages and emails, as well as sharing background information about the study and their role in it, can help alleviate any concerns they may have. Offering an initial, low-commitment call ensures that participants fully understand the study's scope and relevance while providing an opportunity to pre-screen against criteria that could disqualify them before they come in for an on-site visit.
How can phone screens help expedite medical record collection?
During the phone screen, participants can sign a medical record release form. Once it's signed, the caller can assist the participant in gathering records from their healthcare providers and ensure they are sent directly to the research site. If the site isn't able to collect the records before the first visit, a patient enrollment service can securely store the records and forward them to the research site when needed. This is particularly useful if participants are identified before the research sites are fully operational or if there's a waiting period before they can be officially accepted into the study.
How to implement effective phone screening?
Having dedicated professionals who genuinely care about guiding participants through the clinical study process—a journey unfamiliar to most—is essential. To provide the best experience and serve as a valuable resource for participants, research sites, and sponsors,individuals that phone screen need to be thoroughly knowledgeable about the specific study protocols. At PatientWing, we collaborate closely with each sponsor, holding joint educational sessions where sponsors share the key details and significance of the protocols with our phone screening team. These partnerships enhance our ability to assist participants effectively, ensuring the best possible outcomes in the studies we support.
What type of metrics can I get from pre-screeners and phone screens?
We know how crucial data is in driving the success of a clinical study. By monitoring key performance indicators on your study websites—such as awareness, engagement, and conversion rates, along with the number of those who pass the pre-screener and phone screens—you gain valuable insights into your study's reach. This data also sheds light on your conversion rates at the top of the funnel. Analyzing these indicators helps uncover trends, guiding any necessary adjustments to ensure you meet your study's enrollment goals.
If not handled properly, many challenges may arise in implementing pre-screeners and conducting phone screens including:
At PatientWing, we address these concerns and do the work for you! We start by designing a patient-friendly website that includes an online pre-screener and serves as the landing page for interested participants to learn more about your study.
Already have a study website? No worries, we can work with your team on integrating a pre-screener directly onto your website.
Once the participant applies, then what happens? We’ve summarized the details for you below:
Reach out to us today! Discover how our outreach strategies target potential participants and how our dedicated in-house patient enrollment center keeps them engaged every step of the way. Let us help you bridge the gap from interest to enrollment!