DATA AND LOGISTICS
How to successfully leverage technology and logistics into feasibility
Conducting electronic feasibility questionnaires through a system designed specifically for clinical trials has greatly benefited companies that have fully integrated the system into their clinical work flow. Introducing e-feasibility software can be disruptive to existing practices, but if implemented correctly, adds transparency across feasibility, supply, contracts and management. A good tool for e-feasibility will yield higher and faster response rates and ultimately reduce study start-up time. Also, it can allow for the collection of logistical data to reduce risks of operational delays in ongoing trials. Various sources of feasibility data (public, internal and site-reported), can be integrated and maintained through an e-feasibility tool. SiteSurvey is a tool that comes pre-loaded with an address book of sites and investigators. Sponsors are able to seamlessly upload their own data into the system at any time. Subsequently, all questions, surveys and responses are stored, which builds a data repository over time. The aggregation of these sources and storing of historical surveys allows study teams to become more efficient with future surveys as they can create site lists based on previous responses from the site. Survey responses also populate into site profiles, merging those three sources into one clean dataset, which can also be integrated into downstream or upstream systems. Implementing an e-feasibility tool that pre- populates surveys with the site’s most recent answers from previous surveys will save the sites and sponsor significant time. With a pre-populated survey, the site only needs to focus on protocol-specific questions after confirming their existing answers are still valid. Pre-populated surveys have proven to get sponsors between 30% and 40% higher response rates and nearly three times faster response times than a survey that is not pre-populated. This feature also improves site relationships by demonstrating the sponsor saves the sites’ responses and values the investigators’ time.
Study teams with advanced e-feasibility systems have reported saving between three and eight days per survey when analysing results (compared to sending surveys manually or with a less complex system). For a sponsor conducting feasibility on 15 trials each year, this equates to
saving nine to 24 weeks per year of internal time purely spent reviewing responses. Some systems allow for quicker results analysis by allowing users to set up an “answer key” and weight the importance of each question. Real-time results will rank and prioritise sites based on how they replied to those key questions. The sponsor doesn’t even need to open individual surveys where sites answered that they weren’t interested, didn’t have mandatory storage requirements or didn’t have the appropriate patient population. They can more effectively spend time reviewing sites that scored the highest. Study teams can also quickly gain valuable insights into the distribution of answers across all sites. For example, by asking: “How often, in weeks, can your pharmacy receive a shipment of our study drug?” the sponsor will be presented with a dashboard of the median, mean range and country-level breakouts to get true insights into responses across all sites. Technology can also help prevent potential human error or administrative complications that arise with e-feasibility questionnaires. Each sponsor and site will have their own internal requirements when it comes to confidentiality disclosure agreements (CDAs) and working with site networks. In general, a good e-feasibility system should prevent surveys from being sent to sites that don’t have a CDA in place or are part of an exclusive network. This ensures study teams remain compliant with internal contracts teams and agreements with site networks. Although “taking a survey” sounds simple, from
an investigator’s perspective, there are many nuances that technology can accommodate. There will often be additional contacts at the site that need to answer certain questions. Ideally, the e-feasibility system allows for multiple contacts to receive copies of the survey without overwriting others’ information. The ability of these additional site contacts to receive custom communications helps streamline the process and yield higher response rates. Alternatively, if the investigator can’t complete the survey themselves, the functionality for the study team to submit a survey on behalf of a site can be an important feature to look for in an e-feasibility system.
Additional applications for electronic feasibility questionnaires
One common trend arising with teams using e-feasibility is the concept of sending more
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