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10 Minute Read

Your Guide to Clinical Trial Site Selection

The clinical trial site you choose has a direct impact on a trial’s success — for better or worse. Metrics show that poor clinical trial site selection can lead to low recruitment and bad data quality, both of which can push back trial timelines and cause expenses to increase.

Considering that more than 1-in-5 clinical trials are delayed by over 40% of their original timelines1, sponsors must take an increasingly proactive approach in selecting clinical research sites that are not only capable from an operational standpoint but also highly motivated to succeed. Let’s look at some key questions to ask a potential site provider to ensure you’re set up for success at every step of your trial.

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Patient Enrollment

Effective patient recruitment is critical to clinical trial success. The stark reality is that over two-thirds of sites fail to meet the initial patient enrollment needs for a trial2.

With the weight that patient enrollment carries, here are some key questions to ask: How do you set realistic enrollment forecasts?

Clinical trial sites tend to rely on past experiences with similar trials to project patient recruitment timelines. However, these forecasts tend to be overly optimistic as they’re based on best-case scenarios. This can lead to skewed enrollment expectations.

Sponsors should look for evidence of data-driven projections. One example: What percentage of recruited patients from previous screenings passed pre-screening criteria? By taking variables like these into account, site providers can set reasonable, achievable enrollment forecasts.

Can you quickly recruit qualified patients?

Clinical trial delays often stem from difficulties in recruiting enough qualified patients. Potential participants may lack an awareness of available trials or have misconceptions that make them reluctant to participate. Or, in the case of trials that focus on rare diseases or conditions, you may be dealing with inherently small patient populations based on study protocol.

One of the ways sponsors should seek assurance is by asking about a site’s patient database. Having immediate access to a broader pool of potential participants makes it easier to find and match eligible participants to the trial based on relevant criteria. At the same time, look for sites that prioritize targeted outreach to enhance patient awareness, such as collaborations with healthcare providers or community engagement initiatives.

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How do you ensure diversity in patient populations?

In the words of the National Institutes of Health (NIH), “[P]eople may experience the same disease differently3.”  This sentiment helps explain why diversity in clinical trials is moving from recommended guidelines to legislation that would mandate diversity plans from clinical trial sponsors.

Before partnering with a clinical trial site provider, ask for more information about the diversity of their patient database to ensure it represents a wide range of ages, races, ethnicities, geographies, and socioeconomic backgrounds. You should also evaluate if a site’s recruitment and outreach strategies help to reach underrepresented populations.

How do you handle enrollment challenges?

While there are variables that can be controlled in patient recruitment, unforeseen circumstances can also cause clinical trials to under-enroll. For instance, there may be competition from concurrent trials at other sites that are targeting the same population.

During the clinical trial site selection process, sponsors should look for qualities that demonstrate a provider’s ability to pivot fast when these kinds of challenges arise. This starts with analyzing your current strategy to find opportunities for improvement, like revisiting your eligibility criteria, and leveraging a combination of recruitment methods to achieve target goals.

Is your data collection process secure and HIPAA-compliant?

Safeguarding patients’ personal and private health information is critical throughout a clinical trial. While this is a matter of a clinical trial site’s processes, the conversation also extends to the software they use to collect and store patient data. 

Inquire about the encryption methods used to protect patient data, as well as if access controls based on the principles of least privilege are used. Other points of focus include how they monitor their software for vulnerabilities and their protocol for responding to a data breach.

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Patient Retention

It’s one thing to get study participants through the door; it’s another to keep them in the room. As research shows, the average dropout rate across all clinical trials is around 30%2.

With these questions, sponsors can assess how a site approaches patient engagement beyond the enrollment process and tap into examples that underscore these efforts:

What communication plans do you have in place?

As Dr. Brian Southwell of RTI International notes, “[T]rials are social: they involve recruitment of people as participants; they also involve communication with patients, their caregivers, and their families about results and study implications4.” When clear, effective communication is maintained throughout the course of a participant’s journey, the better chances are that interested participants will move forward in the process and stay committed until the end.

Sites that use a clinical trial management system (CTMS) and can reach subjects via multiple modalities are positioned to succeed. Phone calls, emails, and texts should all be used as a means to stay connected to subjects.

Once a participant expresses interest in a clinical trial, how long does it take a site to follow-up with them?

Ideally, this follow-up will take place within 24 hours so you can connect with patients when they are most engaged. This follow-up can include details about the site, the goals and schedule for the study and the benefits of participating.

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As a scheduled site visit approaches, will participants receive appointment reminders?

Proven to reduce no-show rates, this measure can help maintain trial efficiency, as well as data quality and integrity.

What measures does your site take to ensure patient comfort?

While good communication lends itself to a positive patient experience, it’s also important to assess how a site’s physical environment contributes to this effect. Consider what’s available to participants when they’re on-site: Do they have access to Wi-Fi, refreshments, snacks, and other amenities that create a home-like atmosphere? These simple comforts can go a long way in making a participant’s stay more enjoyable.

In cases where there are prolonged wait periods, check to see if participants are offered a private space with comfortable furnishings as they await next steps. Providing meals at no cost during appointments that are longer or require fasting labs further supports a patient-centric experience.

How flexible are you in accommodating participant needs?

At the end of the day, study participants appreciate having options. Let’s say a trial patient runs out of a study supply or misplaces it. Do they have to travel to the site for more supply or do they have the option to have the supply dropped off at their home?

There’s value in a site provider offering this flexibility — to the degree that a sponsor is comfortable with. To this end, it’s valuable to partner with a clinical trial site provider experienced in employing decentralized clinical trial (DCT) principles. That way, they can easily pivot to cater to participants’ needs, making it more convenient for them to stay engaged in the study.

Flexibility can also come in the form of a site’s hours of operation. When sites are open in the evening, early morning and on the weekends, they can better cater to a subject’s needs.

What is your patient lost to follow-up rate?

Knowing the percentage of patients that are lost or drop out of trials at a clinical site is an important metric. High patient lost to follow-up (LTFU) rates can impact the integrity of clinical data while also raising concerns over how a trial will progress in line with the planned schedule. While there’s no set metric that defines a good LTFU rate, you can follow the rule of thumb that less than 5% loss generally leads to little bias5.

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Additional Questions To Keep Top of Mind

What therapeutic expertise do you have? 

When a clinical trial site provider has experience with the condition you’re treating or conditions with similar challenges, they can use that experience to support smoother trial operations. This can extend from patient recruitment to adherence to study protocol.

In conversations with a potential site provider, ask if they can share case studies and metrics from previous trials that are relevant to your therapeutic area of interest.

In the event that a provider doesn’t have experience in your therapeutic area, make sure they have processes in place to predict potential recruitment challenges and any other complications that could be unique to that space.

therapeutic-expertise
How will your team communicate with ours?

When a clinical trial site provider has experience with the condition you’re treating or conditions with similar challenges, they can use that experience to support smoother trial operations. This can extend from patient recruitment to adherence to study protocol.

In conversations with a potential site provider, ask if they can share case studies and metrics from previous trials that are relevant to your therapeutic area of interest.

In the event that a provider doesn’t have experience in your therapeutic area, make sure they have processes in place to predict potential recruitment challenges and any other complications that could be unique to that space.

Find All the Right Qualities
in Remington-Davis

Remington-Davis is a leading clinical trial site provider with over 30 years of experience supporting clinical trial success — with 575 studies completed to date. While industry professionals choose us for our experience, it’s also because of other boxes we check:

Large patient
database

With a database of nearly 16,000 patients and a 35% diversity rate, we have the resources to enable the rapid enrollment of clinical trials while helping to close health equity gaps

CFR 21
compliance

Compliant with CFR 21 Part 11, our CTMS platform allows us to effectively manage recruitment campaigns, enable organized scheduling, and communicate with subjects through multiple modalities

High patient
retention rate

Our 98% patient retention rate reflects our commitment to delivering patient-centric service through regular communications, flexible service, and home-like amenities at our 5,000 square-foot facility

Wide-ranging expertise

Our board-certified physicians have expertise that extends across more than 20 therapeutic areas, from vaccines and general/internal medicine to endocrinology and dermatology

Consultative approach

Backed by dedicated regulatory staff and recruitment team, we have the resources to provide sponsors with a consultative approach at every stage of their clinical trial.

Ready to be our next success story?