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Applied Clinical Trials
Organizations that continue to disregard the technological needs of one of the industry’s core audiences run the risk of having their trials ignored.
More than 10 years ago, the digital revolution came to the clinical trials industry and ushered in a host of new technologies for clinical trial sites worldwide. While a few technologies were lauded, many sites found themselves overwhelmed by the sheer number of new solutions and frustrated as sponsors promoted so many of them that they ultimately made trials harder to run.
In the years since, the industry has responded to site concerns by updating older technologies to be more intuitive and introducing new tools designed with sites in mind. This has helped some sites become less wary of new technology. However, there’s still much work to be done. There are many steps organizations can take to implement a site-first approach that ensures their tools aren’t missing the mark.
One of the most important steps is to include site personnel throughout development of software or systems. This should be done regardless of whether the organization is implementing new technologies or updating existing tools. Sponsors and CROs often have sites they’ve cultivated good relationships with through repeated studies. These sites are important because they are often more willing to offer feedback, speak about existing problems (and ways to solve them), and test new features prior to launch.
Organizations should also consider using existing site relationships to create small task forces or advisory groups to provide feedback, offer suggestions, and test software or processes before they are rolled out externally. When site personnel are not available, consider codeveloping with another third party, such as a trial sponsor or CRO.
System features or updates that reduce site workload or eliminate repetitive actions are also big-ticket items when it comes to keeping sites happy. Features such as visit calculators, contact directories, and easily searchable document exchanges in the site portal streamline operations and enhance efficiencies. Cross-trial features that allow sites to apply credits or actions taken in one trial toward another reduce redundancies. For example, sites that complete and attest to taking good clinical practice training for one trial now have that credit applied across every trial that requires the same training. Technology can also streamline administrative functions and allow tasks to be assigned to specific roles. Communication with sites during setup is critical, because organizations may not immediately recognize every task that leads to repeated actions and inefficiencies.
Integration is another feature the industry hears about frequently. Sites often report that they must use multiple systems with individual log-ons to manage trials, which slows trial execution and adds to site burden. Organizations should do everything in their power to ensure functions can be performed seamlessly within one integrated system. A single sign-on to a portal that contains all the tools necessary to run the trial is much more efficient than having multiple-point solutions that don’t talk to each other.
Technical support is also key. Organizations typically provide this for clients and should do so for trial sites as well. A communication plan with escalation guidelines combined with a searchable contact directory and a document to address frequently asked questions improves the likelihood of site satisfaction, even when technical or process issues arise. Site personnel often prefer to speak to a person in their time zone who speaks their language to resolve an issue.
Many organizations communicate with site personnel on an irregular or as-needed basis. Instead, they should consider creating standard communication practices and establish a cadence for sending updates, feedback, and more. An example of this would be compiling and sending all information regarding upcoming data locks on the first Monday of every week or month. Site personnel who know to expect an email every Monday will be conditioned over time to look for and read the message.
Creating a site-first culture is arguably a necessity as the industry continues to chart the next 10 years of the technological revolution.
KK Rumrill, SVP, Trial Management Services, IQVIA