Sponsors can play an especially critical role in alleviating the three key challenges facing clinical trial site administrators today.
Clinical trial practices are evolving at a rapid pace in an industry increasingly dependent on decentralized clinical trials (DCTs) and digital technologies to support patient-centric, rapid-pace studies. As the use of DCTs and the complexity of technology increases, the burden of administrative responsibilities for clinical trial sites quickly becomes unmanageable.
In fact, recent research from the Society for Clinical Research Sites (SCRS) uncovers the key challenges facing administrative operations for clinical trial sites: oversight of remote vendors, supporting various technologies and, finally, financial compensation. Sponsors can play an especially critical role in alleviating the three key challenges facing clinical trial site administrators today.
Key challenges of clinical trial administration
Oversight of remote vendors
DCTs require significantly more planning when it comes to technology selection, deployment and oversight of remote vendors. There are many vendors in the clinical trial space that are trying to address the needs of all stakeholders simultaneously. This makes the IT landscape of many trial sites a stitched-together landscape of various solutions provided by different vendors.
Effectively managing the use of remote technology vendors for DCTs can be a seemingly insurmountable challenge for administrators. Being able to simplify vendor oversight and relationship management is a critical need.
Supporting various technologies
Different sites and studies will have different technology needs based on the type, size and purpose of the trial. A majority (60%) of sites are using 20+ technology systems on a daily basis. To make the issue worse, many sponsors do not identify the specific technology needed for the trial until the site is nearly open.
Sponsors can inject further complexity into vendor and technology selection. Inflexible sponsors may require that a site uses a specific vendor for a study, even if the site already uses a similar technology solution provided by a different vendor. If sites don’t agree with the requirements surrounding technologies and vendors, they may reject the opportunity to host the trial.
As the complexity of clinical trials and DCTs increases, the amount of work and investment that goes into monitoring and managing clinical trial technologies, vendors and studies, skyrockets. In response, site administrators are demanding greater financial compensation for their efforts.
Sponsors of choice
The sponsor of choice for clinical trials should put the focus on the site and investigator – making their duties easier to manage and execute. This enables significant benefits for the site administrator, including reduced administrative burden by receiving sponsor support in running clinical trials and sites.
Sites don’t have a choice in the technologies or vendors that will be used in a specific trial. So, selecting a sponsor of choice is a critical decision that will determine not only the level of administrative responsibility necessary for a specific trial but also the overall success of the study. To efficiently navigate the complex web of technologies, vendors and processes, sponsors should take a position of leadership and guide the trial and site teams on how to best solve any technology and administrative challenges.
One such area that sponsors can make a concerted effort is ensuring timely and reliable payments to the sites. While this sounds like a simple function, there is much complexity, especially when trials are conducted across multiple countries and regions. Sponsors should look for solutions that use technology and services in a way to ensure payments are processed on time and follow local and global regulations. As a result, site have greater trust in their sponsor of choice, strengthening the relationship and building an open, transparent form of communication.
Streamlining technology use across multiple site & studies
Technology is the key to optimizing and maximizing the value of clinical trials for patients and sponsors. However, simply deploying as many solutions, from as many vendors, as possible creates even further complexity for trial teams and site administrators.
As a general rule, sites tend to be engaged in multiple studies or trials at a single time. Even if each of these studies used the same technologies and vendors, which is rarely the case, the site administrators must navigate multiple different logins and processes for each system or tool. When the studies use different vendors and technologies, the problem becomes even worse.
The key to overcoming technology redundancy and complexity across multiple sites and studies is the integration of various systems, data sets and solutions – enabling once disparate technologies and systems to work together and streamline efficiency of the trial. Clinical trial solutions that enable single platform orchestration and oversight of various technologies and systems used at study sites, regardless of vendor or technology type, reduce administrative burden by consolidating management of once disparate technologies into a single tool.
An integrated, consolidated future of clinical trial site administration
The technologies used to optimize and execute various clinical trial operations will vary based on the site, size of the trial and other factors. While solution availability and variety provide the ability to support many different activities, it also increases the burden of management and oversight on site administrators. Reducing administrative burdens by streamlining technology use and management through the integration of end-to-end solutions will enable clinical trial sites to conduct more studies over time and with greater efficiency.
Melissa Easy is Vice-President of R&D Technologies at IQVIA, responsible for the strategy, delivery and development of technology portfolio and technology-enabled services that improve clinical trial delivery for IQVIA and customer clinical trials more efficiently. Melissa believes we must take advantage of orchestrated technology to bring patients, sites, and sponsors together in a concerted effort to save time, money, and lives. She is a frequent speaker in the industry and has received many awards including PharmaVoice 100 and most recently being named an HBA Luminary.