Strategies for Successful Site Selection in Clinical Trials
Clinical trial site selection can make or break a trial’s success before it even begins. The average cost to open an investigator site is estimated at $50,0001 – a price point compounding quickly when onboarding multiple sites. When you consider around 11% of sites2 fail to even accrue one participant on a given study, cost savings become a major consideration when evaluating which sites to partner with for a trial.
To ensure you’re maximizing the time, resources, and funds associated for each clinical trial, we’ve outlined essential strategies for identifying the appropriate sites, analyzing historical site performance and feasibility, and implementing better communication and tools across stakeholders.
Analyzing Selection Criteria and Site Performance to Identify Your Sites
To identify clinical research sites for a study or trial opportunities, sponsors, contract research organizations (CROs), and sites leverage different datasets. Each sponsor collects data on the trials they’ve conducted and the performance of sites they’ve engaged in the past. A CRO may have more data across more therapeutic areas than a single sponsor. A site has historical performance data of their trials across a variety of sponsors and CROs, along with experience in specific clinical areas.
Each dataset is powerful because there is a lot to learn from past site and trial performance. In which trials have sites achieved their enrollment targets? What is a particular compliance rate with a specific site, or even a particular investigator across different studies? What selection criteria may be inhibiting your trial’s success? And do you have the resources to support sites with less experience in a particular clinical research area, but a strong relationship with a specific pool of patients?
Data like this can help solidify if a site will be a good fit for your unique trial and minimize the risk in your decision. However, each study stakeholder is limited in their decision-making by the dataset informing them. According to our recent trend report, The Current State of Trial Opportunity and Selection, 83% of the polled sites are looking for new trial opportunities, and over half of sponsor and CRO respondents indicated they utilize new-to-them research sites in at least half of their studies.
Consider using SiteIQ, a powerful tool designed to help sponsors and CROs simplify study startup and gain unique insight into site performance and identify high-performing sites currently not within their network. By leveraging Advarra’s data insights sourced from both sites and sponsors/CROs, SiteIQ highlights institution expertise, offers performance metrics from completed studies, and curates customized recommendations to support the needs of individual studies beyond your in-house dataset.
Factors Influencing Site Selection
Communication is an essential part of any effective clinical research relationship, and it’s important to always engage with each site thoroughly. Even if a particular clinical research site isn’t a fit for your current trial, they may be an important partner in future studies. Building these relationships will help you down the road, and can increase transparency between stakeholders.
There is a bi-directional need for communication. Sites need to feel comfortable being honest and transparent about how they think they’ll perform on a study. And even though they’re working with a lot of sites, sponsors need to allow some flexibility in getting information for the site to highlight why they’re an appropriate site for the study. This conversation gives sites the ability to communicate where their true strengths and weaknesses are.
An open line of communication can help to improve site management and engagement in the long term. The site evaluation process is a learning opportunity for everyone involved, and processes like study feasibility questionnaires (SFQs) can prove useful for all stakeholders involved. Our trend report found sponsor organizations are generally seeking to learn about four key evaluation items when selecting a site:
- Experience with patient population
- Clinical research experience
- Access to patient population
- Historical performance of enrollment
An SFQ introduces the opportunity for sites to answer sponsor’s key questions and provide additional information, but low site response rates have contributed to frustration—only about 65% of SFQs sponsors and CROs distribute are completed and returned.3
On the other hand, sites are also frustrated by the lack of feedback. We found 83% of sites want more study opportunities, but rarely receive feedback from sponsors and CROs on why their site was not chosen. The lack of communication doesn’t help to foster site relationships, and missing insight likely contributes to low SFQ response rates.
Leveraging Technology in Site Selection
Technology is absolutely vital to a study, and you need a reliable way to store and collect data. Successful site and sponsor/CRO relationships are better enabled with tools designed to bring more insight to the conversation, while ensuring data is reproducible and properly communicated.
Oftentimes, relationships between sites and sponsors are very protocol-specific. Sponsors and CROs typically rely on an SFQ to gather site information. However, sites do not feel the SFQ allows them to properly highlight their abilities to conduct research. The sponsors rely on the SFQ and if the site doesn’t meet the criteria, they are not considered any longer. In some cases, this is in error as a follow-up conversation about the sponsor’s findings and probe of the site may find they actually are qualified and well suited to take on the study.
Communicating beyond these rigid questionnaires can allow for negotiation opportunities, potentially resulting in a highly successful site and clinical trial partner for a sponsor/CRO. The right tools can ensure mutual success, such as additional training resources, a financial feasibility analysis, and a centralized institutional review board (IRB).
It’s important to remember there is a time frame between selecting and activating a site, during which these tools can be implemented. A typical academic medical center may take up to six months on average to activate a trial, while an independent site may take 30-45 days before enrolling patients.4
Another essential step before activation is aligning on standard definitions for operational metrics — establishing common terminology when discussing how activation and trial conduct activities are proceeding. This step will optimize the workflow between all of the trial stakeholders, and can ensure the research is measured with the same set of conditions.
How Advarra can help
At Advarra, we work to advance clinical research through innovative solutions designed to leverage our industry expertise, optimizing your trial all the way from initial research to market.
To streamline site identification for your clinical trial, consider leveraging Advarra SiteIQ. The study planning tool was designed to simplify study startup by identifying suitable sites for your clinical trial using Advarra’s comprehensive database.
- Optimizing Clinical Research Operations with Business Analytics, https://support.sas.com/resources/papers/proceedings11/204-2011.pdf
- Coalition for Clinical Trials Awareness, http://cctawareness.org/about-us/
- Trend Report: The Current State of Trial Opportunity and Selection
- JCO Oncology Practice, https://ascopubs.org/doi/full/10.1200/OP.19.00325