The Unsung Heroes: A Dual Focus on Patient and Site Experiences

This blog was authored by Paul O’Donohoe, Senior Director, eCOA Product and Science at Medidata.

As we continue to innovate and evolve in the clinical trials space, the spotlight has rightfully shone on improving the patient experience. The emphasis placed on patient centricity is crucial, aiming to minimize burden and enhance the overall journey for patients who are often navigating the most challenging periods of their lives. This strategy remains at the core of how we approach technology development, with a focus on electronic clinical outcome assessments (eCOA) and decentralized clinical trials (DCTs).

An aspect that warrants equal attention—but is often overlooked—is the site experience. The success and efficient running of clinical trials heavily rely on sites, which serve as the crucial link between patients and the actual conduct of the trial. The onus of recruitment, setup, and ongoing support predominantly falls on them, making their role indispensable—and burdensome!

The obstacles sites face are multifaceted. Initially, the transition to browser-based solutions for capturing case report forms (CRFs) marked a significant leap toward improving the site experience. As technologies and capabilities evolved, the expectations placed on them have expanded. On top of their primary job of looking after patients, sites are now pivotal in registering and recruiting patients into trials, setting them up with patient-facing technologies, and providing initial—and ongoing—troubleshooting support. The increase in responsibility, (rarely matched with an increase in resourcing,) has contributed to the growing technical burden placed on sites, emphasizing the need for solutions that simplify these processes.

A primary challenge sites encounter is the management of multiple disparate technology solutions. Each trial may require different platforms for electronic data capture (EDC), patient consent (eConsent), and patient assessments (eCOA), among others. This not only demands significant training for already overstretched site staff, but also requires the juggling of numerous login details and interfaces, leading to considerable administrative strain. The hardware required for different trials adds another layer of complexity, with sites often finding themselves operating a plethora of devices specific to each study, making their setup, management, and tracking even more difficult.

Recognizing these issues, we've partnered directly with leaders from across the world through the Medidata Site Tech Board, powered by SCRS, to elevate the site voice. We are dedicated to creating a unified and intuitive solution, centralizing all the tasks sites need to complete into one location through the Medidata platform.

The new Medidata App exemplifies this effort, offering a seamless solution for sites to manage eCOA studies and broader DCT experiences. With all of their trials accessible via a single login, visit setup for patients is simplified, and study activities can be managed more efficiently. Reducing the logistical headache associated with technology management avoids the trickle-down effect in which frustrations with siloed systems and hardware snowball into negative consequences for patients. A good site experience translates to a positive patient experience. And, indeed, a good patient experience leads to an easier life for sites; once set up in the myMedidata app, patients are largely guided by the system, with the access and ability to smoothly manage their own trial journeys, yet still connect with their site team as needed.

Looking ahead, it's clear that the path to ensuring the success of the ever-more complex clinical trials we’re seeing lies in ensuring both patient-centric approaches and site-centric approaches.

So much of the hard work that goes into a trial sits on the sites’ shoulders; the immense burden incurred by moving from one solution to another and interacting with different technologies and workflows must become a thing of the past. 

In our continued work with the Site Tech Board, Medidata is leading the charge in addressing these challenges head-on via a single, interconnected platform that unifies all of a site’s tasks in one place to simplify their interactions with technology. This ensures an easier and more efficient trial process, and directly benefits patients by letting sites focus more on care and support rather than being bogged down by technological complexities.

“Working with the Medidata Team is always a pleasure. The energy is contagious, and it's exciting to be a part of a group that is so passionate about what they do and works towards a common solution. The workshop was a fantastic experience, and I can't wait to see what the team will do with the insights.”

– Medidata Site Tech Board Member

Medidata is committed to pioneering this balanced approach, recognizing that empowering sites with the right tools and technologies is integral to achieving a harmonious patient and site experience. 

Enjoyed this article? Click here to share it with your network.