By Jimmy Bechtel, Society for Clinical Research Sites
Technology is a critical part of clinical trials, and sites have been utilizing decentralized technologies for enough time to know some of the major challenges these technologies can bring. Most importantly, however, they are also keenly aware of potential solutions to those challenges.
With some of the more granular issues aside, one of the major challenges sites often experience is the lack of integration, unification, or standardization of these technological tools. This can be seen as the root of several issues, such as the tremendous amount of site staff training required for a trial, the training a patient has to complete, as well as the increasing costs of adopting technologies and the staff needed to manage them.
Time To Get Out Of “Pilot Mode”
What has been observed and vocalized by the site community is that when a partner at the sponsor or CRO level adopts various solutions, they rarely do so across the entire company or even across a particular portfolio. Sites feel as though they are participating in a “pilot” mode, where industry partners are trying new combinations of technology and services, even within their own therapeutically aligned teams. This practice demands that both sites and patients go through new training and incur additional costs that could be otherwise avoided if a sponsor chose a familiar process or solution. When a new solution or piece of tech for a study is adopted, sites have to start over in learning and operationalizing that tech. This comes with additional time, cost, and resources that are not typically recognized or reimbursed by the industry partner. To put it into perspective, data from the 2022 SCRS Site Landscape Survey indicated that sites spend an average of 10 to 20 hours per month per staff member per trial on training for trials with decentralized elements. Furthermore, 45% of sites surveyed shared that supporting all the different technologies needed for different studies and sponsors was one of the biggest challenges they face today.
The clinical research site community is urging industry partners to reduce the practice of switching technology solutions for clinical trials in order to improve efficiency and sustainability. The ideal solution is to get out of this pilot mode as soon as possible and begin to settle into solutions that will be accepted and utilized across their business. Start with therapeutically aligned teams and go from there. The goal should be the universal adoption of a specific solution to a particular aspect of decentralization, such as a single telemedicine platform or ePRO, so partner sites can rely on that consistency. Knowing in general what sites can expect from trial to trial will allow them and their patients to operate much more efficiently and control associated costs.
Allow Sites Flexibility To Choose Their Own Tech
Many sites are already electing to adopt their own technologies and service solutions to achieve their goals of minimizing training, reducing costs, and improving overall operations at the site level. This trend will require flexibility from the industry partner when it comes to adopting home health or home nursing capabilities, for example. If a site has an agreement with a regional provider of these services, it is not to the benefit of any party to require that the site instead adopt the solution being provided by the industry partner. If industry partners are not flexible enough from a data receipt perspective, they may lose the opportunity to continue their relationship with sites that have taken the initiative to adopt their own solutions. Sites may dig their heels in if asked to use something else because of the undue burdens that come from new technology adoption. Being flexible and allowing the site to use technology that it has determined to be the most efficient way to execute the trial is a recipe for success.
Integration Is Crucial For Lasting Success
More importantly, sites need solutions that can be safely integrated with one another if the goal is to help improve clinical trial efficiency and site sustainability. Integrating technology will reduce strain on the staff associated with protocol start-up, data collection processes, communication between investigator sites and sponsors, as well as compliance with international regulatory requirements. A truly lasting technology solution will have the ability to manage data from multiple sources, or at least integrate in ways that enable flexibility within that clinical trial so that sites and industry partners can maximize their time and resources.
Additionally, integrating systems may lead to better quality assurance programs for monitoring safety events throughout the study participation time frame at each site globally. These changes may help ensure long-term success for drug development programs while reducing strain on staff associated with protocol start-up every few years or even months. We have done this with other clinical trial solutions, such as EDC, in the past, so we know it can be done again.
The collective voice of the sites is asking for streamlined, well-integrated technology so that we can maximize our patient-facing efforts and execute our clinical trials efficiently. Technology integration is key to improving clinical trial efficiency and site sustainability, and these solutions also need to work toward being integrative so that flexibility can begin to make its way into clinical trials. Industry partners need to begin adopting consistent technology and services to enable decentralized trials across their businesses so that sites can begin to adopt consistent practices as well.
We speak about decentralized trial elements, solutions, and services as being flexible options for patients, but if they are not flexible and not conducive for site participation as well, we won’t be getting very far very fast. By reducing the frequency of switching technology solutions, pharmaceutical sponsors can ensure long-term success for drug development programs while minimizing strain on site staff associated with protocol start-up. Now is the time to make meaningful changes with technology adoption that will have a lasting impact on clinical trials.
About The Author:
Jimmy Bechtel is vice president of site engagement for Society for Clinical Research Sites (SCRS). He is in charge of developing and executing the company's site-facing initiatives and works closely with key industry partners to build out various SCRS partnership programs. Bechtel brings experience from both the site and sponsor sides of the clinical research industry. In his site experience, he served as a data specialist, patient recruiter, and operations manager. In his pharma experience, he worked in innovation project management, encouraging a site-centric environment and creating ease for sites working with a major sponsor company.