Importance of a Customizable, Integrated Ecosystem in Clinical Trials

 

Novel vaccines and diagnostics were developed in record time to address the COVID-19 pandemic, but the typical clinical trial process remains slow, stalled by friction at nearly every point in the process. Study startup, for instance, represents the biggest opportunity to remove friction, reduce the technology burden, and enhance transparency for research sites, sponsors, and contract research organizations (CROs).

Remove friction from the start

Per Advarra’s 2023 study activation survey, sites report set-up and training on sponsor-provided technology systems to be the most burdensome activity they face, even more than contracting and budgeting, which historically have been rated as the most arduous aspects of study start-up. In fact, sites report more issues using sponsor-provided solutions, with two-thirds saying the burdens are greater now than just five years ago.

With more technologies piling up, the current clinical model is reaching a tipping point. Technology friction is causing not only inefficiency but also a negative downstream effect on the sustainability of the trial site workforce. A 2022 analysis by the Tufts Center for the Study of Drug Development (CSDD) revealed that 66 percent of principal investigators (PIs) in North America leave research after conducting just one trial, leaving a gaping staffing hole. PIs often walk away because excess administrative burdens in trials pull them from what they care about most: Patients.

Connecting the clinical trial ecosystem while giving sites technology choices is key to reducing the friction in the study startup process, alleviating unnecessary burden on sites and staff. This requires interoperability between site and sponsor systems.

A connected ecosystem will:

• provide sponsors, CROs, and sites transparency and easier access to information across various platforms, 
• automate workflows to accelerate research and reduce inefficiency, and 
• streamline document exchange to help ensure compliance and audit-readiness.

Reduce technology burden while preserving site choice

Clinical research sites are being asked to implement more sponsor-provided technologies, including electronic data capture (EDC), electronic clinical outcomes assessment (eCOA), interactive voice response (IVR), and safety letter systems. The unintended consequence of technology proliferation is a high number of different websites, logins, and passwords for site staff to manage. 

Sites typically have six or more different logins per study for all the systems they use to conduct trial tasks. Adavarra spoke to Patricia Larrabee, MSN, NP-S, consultant for Rochester Clinical Research and Atlas Clinical Research, who said sponsor-provided systems combined with site systems can add up to “north of a dozen different systems for a single trial, each with their own login.”

Standardizing on a single technology stack seems an obvious solution but not all sites are the same: The needs and experiences of an academic medical center, hospital system, and private site differ. Sites want the ability to pick solutions that are tailored to their unique needs, people, current processes, and standard operating procedures.

Flexible, customizable ecosystems work best

The better option for sponsors is to present a flexible ecosystem that both supports technology-naïve sites and offers customizable options to technology-enabled sites, but with connectivity to allow a frictionless flow of processes, data, and documents—without logging in and out of different systems. Seamlessly integrating existing and preferred systems with sponsor-mandated systems—that can vary from trial to trial—will simplify site work for both sponsors and non-industry funded studies. 

Ideally, sites can perform an activity once and flow it through every system. Around 81 percent of survey respondents indicated that they would find connectivity between their eRegulatory systems and sponsor technology very or extremely valuable. Connected patient engagement tools, like recruitment trackers, can also enhance the site–patient relationship. When all these technologies are integrated, everyone benefits through a single user experience.

Let’s connect for a better clinical future

Study activation involves basic steps that are similar across the industry. Yet it remains one of the most challenging aspects of a clinical trial. 

The clinical research industry is paving the path to a new model that integrates technology for a connected clinical ecosystem. It is only through this path that the industry can reap the benefits of acceleration, compliance, and transparency, while allowing sites the freedom to define their processes, with or without technology of their choice.