Tips for lowering clinical trial site burden

Clinical trial sites are the physical locations – often hospitals or other medical facilities – where clinical trial participants go for in-person enrollment, study visits, treatments, and/or follow-up appointments. A given clinical trial usually involves multiple sites, which enables access to patients from a wider geographical area and distributes the workload across staff. One challenge clinical trials encounter is site burden, and in this article we’ll go through:

What is clinical trial site burden?

  • Why is managing site burden important?
  • What are some factors affecting clinical trial site burden?

Tips on 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 refers to the overall pressure and workload placed on a particular clinical trial site and its staff in terms of their responsibilities and expectations for the trial - namely the tasks to be carried out and the timelines to follow.

Why is managing site burden important?

Site burden not only affects the clinical site staff carrying out the activities of the trial, but also the trial sponsor, as logistical bottlenecks can result in delays, monetary losses, or even instances of non-compliance with regulations. Further, patients can suffer as a result of excessive site burden when the site does not have proper capacity. In short, site burden affects everyone involved in a trial.

If the tasks and timelines of a trial are unmanageable for the capacities of the site staff, some of the problems that could arise include:

  • Reduced enrollment rate
  • Undue stress on site staff
  • Higher likelihood of errors
  • Reduced patient retention
  • Mismanagement of study supplies
  • Trial delays

Managing site burden is important to minimize risk, optimize efficiency and data quality, and ensure the health and well-being of patients and study staff alike.

What are some factors affecting clinical trial site burden?

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

  • Trial timelines and targets
  • Number of sites
  • Facilities and equipment
  • Staffing and capabilities at each site
  • Study supplies
  • Number of participants at each site

Site burden could be conceptualized as a result of necessary compromises between two main resources; time and money. Individual site burden could be reduced significantly and efficiency could be improved by involving a greater number of sites, but this would require increasing costs related to paying staff, distributing supplies, and managing and overseeing increasingly complex operations.

Seen differently, within a given budget, adding more trial sites reduces the resources that can be allocated to each, increasing the risk of running into issues with site burden. On the other hand, cost savings arising from focusing resources across the minimum number of sites could mean it takes longer for the sites to see all patients, complete all the study visits, and gather and process data.

Tips on reducing clinical trial site burden

Optimizing sites and reducing site burden is a complex challenge for clinical trials that does not have a catch-all solution. In this section, we will briefly cover some key areas that impact site burden – focusing in particular on two phases that tend to be hotspots for site burden – and then dive into some technological solutions for reducing site burden.

Reducing site burden by focusing on study design and recruitment operations

Study Design

Challenge: Decisions made during this phase, on topics like site selection, site activation, protocol design, and study conduct all end up impacting site burden directly.

Selecting the number of sites required and identifying a sufficient number of sites to conduct the trial presents one of the biggest challenges. Sites need to be in a location where they will have access to the right patient pools, be equipped for the trial, and have the right investigators ready.

3 ways to address this:

  1. Site selection: Consider what parts of the protocol could be conducted virtually and where in-person visits will be required. Mapping out the complete protocol with potential hybrid options could reduce site visits. Some settings include: the clinical trial site, patients’ homes, virtual visits, or a mobile clinic.
  2. Site activation: Realistic enrollment targets and site activation timelines can reduce site burden by reducing the number of unnecessary site activations. Site activations typically account for the majority of the enrollment cycle and can be reduced by setting appropriate targets and investing in patient recruitment planning.
  3. Study conduct: The study conduct phase presents ample opportunity for engaging health-tech solutions that can reduce site burden by automating tasks, streamlining operations, and enabling decentralized opportunities. In order to reduce burden, the tools should work together to create a smooth tech-stack, so planning is required to ensure the tools aren’t increasing strain due to their complexity and/or incompatibility.

Recruitment Operations

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.

3 ways to address this:

  1. Leverage inbound recruitment platforms: Connect with patients that are looking for your trial. Power, which is a patient recruitment marketplace, can help sites access high-intent patients who are actively searching for clinical trials but who are not currently in their site database. Solutions like Power, which are intentionally designed to reduce site burden, can be powerful tools for accelerating enrollment timelines.
  2. 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.
  3. Flexible staffing: Sites may experience periods of high burden, and if the problem is only temporary, due to an unexpected volume of patients, staffing can be augmented at this particular site.

Decentralization and technological solutions to reduce site burden

In general, an effective way to decrease clinical trial site burden is to leverage software tools or clinical research management platforms that either automate or otherwise make it easier, faster, and/or more secure for sites to collect and manage study data, interact with patients, manage documentation and records, and comply with regulations.

There are many robust technological solutions available on the market to facilitate clinical trials for sponsors and trial sites alike. One promising development has been the introduction of electronic patient-reported outcomes (ePRO) and other remote- or internet-based data collection and communication tools. In many cases, certain aspects of clinical trials can be conducted remotely - decentralization of typical trial tasks is a promising way to alleviate some of the burden placed on physical trial sites and their staff.

Technological clinical trial management tools can:

  • Accelerate patient recruitment
  • Enable real-time data collection
  • Enhance and streamline data verification, processing, and analysis
  • Validate, secure, organize, and optimize data
  • Suggest conclusions from raw data collected in real-time
  • Reduce manual data entry and processing tasks and errors
  • Help monitor trial progress and adherence to protocol
  • Help with managing numerous trial sites and keeping them up-to-date
  • Improve patient satisfaction and experience
  • Help ensure continued adherence to regulatory and legal frameworks, further acting as digital records of proof of compliance


As we have seen, there are various ways to lower clinical trial site burden, and the appropriate solution will vary for different trials. Site burden represents a complex and dynamic interplay of various factors, and it should be monitored throughout the course of a study. Keeping site burden in check is one aspect of ensuring that patients receive optimal care and maximizing the outcomes of a clinical trial.

Beyond proper planning and management of trial sites and monetary and human resources, contracting external partners and clinical trial management tools are promising ways to reduce the burden on trial sites.