Tips for lowering clinical trial site burden

The trial sites activated to carry out clinical trials are often functional hospitals or clinics, and they generally have a lot more on their plate than the single trial. With the site’s facilities, staff, and other resources being limited, it’s important as a sponsor to make an effort to manage the burden imposed on a site by your trial. Proper planning in this regard can help the site maintain efficient operations and manage stress, which will have positive spillover effects in terms of its capabilities to run your trial smoothly. In this article we’ll look at the concept of site burden in clinical trials, working under the following structure:

1. What is clinical trial site burden?

Why is managing site burden important?
What are some factors affecting site burden at a given site?

2. Tips for reducing clinical trial site burden

Reducing site burden by focusing on study design and recruitment operations
Decentralization and technological solutions to reduce site burden

What is clinical trial site burden?

Site burden can be conceptualized as the overall pressure and workload placed on a particular clinical trial site and its staff in relation to their responsibilities within the trial and your expectations as the sponsor.

Why is managing site burden important?

Excessive site burden can directly impair the ability of the clinical site and its staff to carry out the basic operations of a clinical trial amidst their other responsibilities. In turn, it can have consequences for the trial sponsor and patients. Logistical bottlenecks at a single or multiple sites can cause trial-wide delays, with potential associated monetary losses or even instances of non-compliance. The quality of patient interactions can decline drastically when staff are overwhelmed, leaving the patients feeling unseen or shorted and raising the risk of protocol non-compliance and attrition. In short, site burden can impact everyone involved in a trial.

If trial-related operations are unmanageable for the site, either in terms of capacity or adherence to timelines, various problems could arise:

Subpar accrual rate
Increased likelihood of errors
Poor patient engagement and low retention rates
Mismanagement of study supplies
Non-compliance
Delays

Managing site burden is important for minimizing risk, optimizing site efficiency, and ensuring adherence to quality and regulatory standards across individual sites.

What factors affect clinical trial site burden?

Site burden is a dynamic concept that represents an interplay between multiple factors, such as:

Trial timelines and performance targets
Number of sites activated (related to the number of patients per site)
Availability and conditions of facilities, equipment, and materials at each site
Staffing and general capabilities at each site
Study supply management
Experience of the site and its staff in managing stress, and typical workloads

Site burden across all sites activated for a given trial can be balanced by appropriately allocating resources according to site capacities. Burden at an overburdened individual site can be reduced by activating more sites, spreading out the study population. But this comes with heavy costs related to site activation, and runs the risk of involving sites that won’t see a substantial patient base. Further, under a fixed study budget, adding more sites also reduces the amount of resources that can be allocated to each, counterintuitively increasing the risk of running into issues with site burden. Focusing resources too narrowly across a reduced number of sites could mean it takes longer for the sites to see all patients, affecting patient satisfaction and also increasing the risk of manual errors.

Optimally balancing resources across sites requires consideration of site performance, trial timelines and budget, as well as the geographic spread of the target study population (aim to minimize travel time on the whole to reduce patient burden). For more information on site selection, see: Optimize Clinical Trial Site Selection in 4 Steps | Power.

Evidently, decentralized clinical trials, where they are possible, offer a solution in many of these regards, or eliminate the question of site burden altogether (more on this below). Assuming we are dealing with in-person trials involving one or more study sites, we will have a look at a few ideas for reducing site burden.

Tips for reducing clinical trial site burden

Each site has its own operations, protocols, and experience, but as a sponsor, there is a lot you can do to help them run your trial smoothly and efficiently. Here, we briefly cover two primary aspects that tend to heavily influence how smoothly a trial operates at a given site, and offer some technological solutions for minimizing site burden.

Here’s the summarized version: site burden can be managed to a large extent by designing trial protocols that are optimized for efficiency from the get-go, and recruitment deserves special attention and support from the sponsor as it is a common bottleneck.

A) Study Design

Challenge: Decisions made during study and protocol design can heavily impact the burden your trial places on sites. Study design should foresee potential bottlenecks at sites and aim to reduce patient burden as well.

3 ways to address this:

Consider alternatives to in-person visits: Where in-person study visits are required, protocols should be streamlined to support the collection of only essential data to power the study. Every visit should be instrumental in gathering the necessary data to resolve the research question. If a given visit would not be essential in this regard, it can likely be replaced with another form of follow-up or check-in.
Take advantage of tech: With modern tools, there are many types of data that can be collected remotely, easing scheduling efforts and keeping the burden on sites in check. Direct data capture (DDC, or electronic data capture, EDC) has numerous additional benefits, highlighting real-time insights, enhanced data accuracy, and improved patient satisfaction as a few examples. Overall, eClinical solutions can significantly reduce workloads associated with manual data collection, transcription, and reporting, and can also, to a large extent, replace aspects of on-site study monitoring. If your organization has not yet fully embraced technological advancements in this regard, a good starting point could be to partner with a trusted provider to begin comfortably integrating helpful tech solutions into your protocols.
Actively monitor site performance: Multi-site trials are a dynamic entity, and managing burden across sites requires being attentive to changing conditions as the trial progresses. Solid recruitment targets are those that can be met realistically, but which can also be handled by the site. If a site is falling short, consider boosting recruitment efforts in novel ways (more on this below) before jumping to costly activation of a new site. Keep communication open to ensure that sites are able to give patients proper attention, and consider sending in additional support rather than compromising on quality of care. An efficient study protocol lays the foundation for smooth operations, but site operations can be facilitated through continual attentive support on the part of the sponsor.

B) Recruitment Overhead

Challenge: Once the planning and startup phase is completed, recruitment operations can be a constant source of site burden as the site seeks to hit its enrollment targets.

Sites often struggle to meet enrollment goals solely from their initial database and pool of patients. As a result, they often need to meet timelines while filtering through huge volumes of patient referrals. Traditional patient recruitment methods are outdated and inefficient.

3 ways to address this:

Leverage inbound recruitment platforms: Connect with patients that are looking for your trial. Power, a modern patient recruitment marketplace, can help sites and sponsors access high-intent patients who are actively searching for clinical trials. Solutions like Power are powerful tools for accelerating enrollment timelines, reducing the associated burden placed on sites in the process.
Reduce friction for patients and therefore sites: Make it easy for patients to understand the trial they are applying to, and provide critical information upfront to avoid receiving huge volumes of patient referrals that won’t be a match. Increase the likelihood of receiving qualified patients by using pre-screeners, providing information in plain English, and making it easy for patients to understand whether or not the trial is a right fit for them. The FDA recently released draft guidance regarding what information should be presented to patients to facilitate their understanding of the trial.
Address systemic barriers: This issue can also be tackled indirectly by addressing systemic issues of accessibility, including disparities in research representation among underrepresented groups. Although the impacts will be realized slowly, they also span a broader scale, and the urgency of addressing diversity in trial populations has taken center stage. Patient education and awareness campaigns empower people to take an active role in their health journey, and can help defuse distrust in clinical research and dispel myths that prevent people from joining trials. Trials should be accessible to everyone, and engaging with diverse groups can help you understand how to be inclusive of varied populations. Improving diversity in trials is important for ensuring that drug approvals and other public health decisions are based on representative data gathered from inclusive studies. When access barriers are removed and patients are trusting and informed, recruitment can shift even further toward inbound methods, reducing the burden on sites and sponsors to reach out to find patients. The topic of patient centricity offers some valuable insights for prioritizing the patient experience and making clinical trials more attractive: Putting Patients First: A Guide to Patient Centricity in Clinical Trials | Power

How decentralized trials and technology can reduce site burden

As we mentioned, site burden can be minimized by making smart use of eClinical solutions. A well-matched tech stack will make it simpler, faster, and more secure for sites to collect and manage study data, monitor patients, organize documentation and records, and demonstrate compliance. Integration with a central server means that data can be organized coherently and in real-time across all sites. This also opens up the possibility for centralized or risk-based monitoring approaches, doing away with time-consuming on-site monitoring. A spillover effect is that the record-keeping responsibilities of sites are facilitated greatly.

There are many robust technological solutions available to facilitate trials. Many providers offer end-to-end solutions that are readily customized. Below we briefly mention some of these tools and how they serve to reduce site burden. Follow the links to our articles going into more depth on these solutions.

Common eClinical solutions and how they can lower clinical trial site burden

Power: Use a modern recruitment marketplace to expand reach to new patient pools, improve diversity, and take the recruitment burden off of individual sites.
DDC/EDC: Capture data directly into electronic records, minimizing manual recording and transcription work and supporting data integrity and accuracy.
ePRO: Let patients input data themselves, where they are and in the moment that symptoms strike, reducing recall bias and facilitating patient engagement.
CDMS: Optimize data collection, management, validation, and cleaning, reducing manual data management workloads.
eConsent: Let devices help explain the trial consistently and in simple language, leveraging interactive features to enhance comprehension and engagement.
CTMS: Integrate various features into a tech stack fit for your specific trial, supporting regulatory compliance, monitoring, data management, and more, leaving sites to focus on patient visits.
eCRF: Record patient data directly in electronic format, keeping records coherent and taking advantage of edit checks and many other advanced features that paper forms simply don’t have.
eQMS: Tackle quality control in a centralized manner, reducing on-site monitoring and lightening some of the stress placed on sites.
Artificial intelligence (AI) and machine learning (ML): The potential uses are too numerous to list here, but AI is proving revolutionary in optimizing efficiency in trial workflows through automation of tasks, generation of draft documents, personalized interactions with patients, and many more interesting use cases.

Conclusions

There are various ways to keep clinical trial site burden in check, but it begins with solid planning in the study design stage. Site burden represents a complex and dynamic interplay of various factors that will differ between sites, so it’s important to keep sites engaged and monitor their performance throughout the course of a study, potentially intervening when necessary. Keeping site burden in check is critical for ensuring that patients are receiving optimal care and reducing risk.

Efficient modern trials draw upon various tools to streamline and improve workflows. Relying on paper records and stale patient databases is a thing of the past, and sites will be more eager to pick up trials that are optimized for efficiency at the level of the sponsoring organization.