Modernizing Site Feasibility and Selection
Study startup is a complicated, multi-faceted process – notoriously prone to delays due to the many stakeholders, systems, and decisions involved. One decision that can greatly impact the success and efficiency of your study is determining which sites you will partner with to conduct the study.
Historically, this process has been littered with pain points and inefficiencies for both sponsors, contract research organizations (CROs), and research sites. Overoptimistic investigators, redundant and duplicative site feasibility questionnaires (SFQs), lack of communication across stakeholders, and more leave room for risk of zero or under-accruing trials. By optimizing your approach to site feasibility and selection, you can remove barriers preventing research sites from delivering the best possible experience for trial participants—and the best possible results for your organization.
The Role of Site Feasibility Questionnaires
Currently, site selection is largely informed by feasibility questionnaires, typically in the form of a survey sent to all prospective investigative sites via email with a fillable survey document attachment or hyperlink to a data capture form field. However, without suitable analytical tools, survey responses gathered from sites may fail to provide enough relevant information to make an informed decision on whether the site is truly capable of reliable performance against the trial protocol. After all, simply collecting data isn’t enough. Establishing a method to collect and analyze relevant and actionable data is a must. Advarra API Gold Partner Devana Solutions’ PROPEL software improves workflows around creating and sending questionnaires in addition to automating data collection and reporting.
Many feasibility questionnaires are antiquated and redundant. They often ask the wrong questions and fail to collect the information required to yield the best decisions. A recent survey conducted by Advarra revealed over half of site respondents don’t believe an SFQ accurately represents their sites’ capabilities. A more precise and accurate feasibility process should provide a realistic assessment of current site capabilities – both therapeutic and physical or facilities-related – and be backed up by historic performance data captured during previous clinical trials completed by the site organization. Today, using a digital platform or software is a must in order for site selection and feasibility analysis professionals to quickly distribute feasibility surveys or questionnaires and, similarly, following distribution to the site-based staff to capture, store, analyze, and act upon site responses.
Obviously, some standard qualifying questions and evaluations about site baseline capabilities must always be included as prerequisites, such as a site’s financial viability and available staff and physical resources like the presence of onsite freezers or secure drug storage units and a patient database, but it’s also important to consider many of the following items during site selection and feasibility:
- Past study performance in terms of startup timelines, enrollment, and outcomes
- Current staffing numbers and turnover rate
- Competing studies potentially impacting patient enrollment
- If the indication is relevant to the site’s local population
- If the study protocol and framework suit the site and region
Beyond simple questions, feasibility surveys can also provide guidance to the site, particularly around aspects of patient recruitment potentially helping to qualify the site organization’s level of interest in being selected for an upcoming trial. For example, incorporating questions in the survey about best practices undertaken in the past by successful sites on a similar study, indication, or patient population, may help to improve the accuracy of your feasibility survey responses. If a texting campaign for patient recruitment worked well in a similar location before, it may be worth adding a question asking the site organization to detail its breadth of marketing capabilities.
Building a more focused set of questions tailored to your specific study will provide you with more robust and actionable site responses. Including such questions will give you more specific insights for use during site visits or follow-up conversations with site-based staff. Good or bad, these findings can help you target the sites most likely to succeed on a trial while saving time and money by avoiding those that might not be a good fit. Site responses can also help influence potential protocol adjustments since sites maintain and foster a relationship with their patient population and tend to have a good grasp on if procedures may or may not be well tolerated.
Communication is the Key to Success
Whether a site is accepted or rejected for a study opportunity, it’s important to provide feedback and communicate clearly to site staff so they can accurately respond to feasibility survey questions and address any deficiencies before the next trial opportunity. In Advarra’s recent survey, respondents revealed almost one in five sites never receive feedback, and another 34% of sites state they very rarely receive feedback on why they were or were not selected for a study.
Naturally, such communication should go both ways. By providing the opportunity for site staff to provide comments or more open-ended answers to some questions, you may yield more useful insights about the protocol, the local patient population, past recruitment successes, and more. Even when communicating rejection or non-award to a site, it can still help establish trust by clearly stating why the decision was made and freeing up that site’s resources for other studies.
About Devana Solutions
Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Our platform bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trial systems.
Devana Solutions is an Advarra API Gold Partner that integrates seamlessly with Advarra’s Clinical Conductor CTMS. Learn more about Clinical Conductor CTMS, Devana Solutions, and other Advarra partners.