The Clinical Trial Site Experience – Helping Sites ‘Break Out of the Escape Room’

Hearing a leader from the clinical trial research site community describe the site experience as trying to “break out of the escape room” is enough to give anyone pause for thought.

The commenter was Viviënne van de Walle, co-founder of the independent clinical research site, PT&R, and a member of the leadership council for the Society for Clinical Research Sites (SCRS). Viviënne is a highly respected voice in the clinical trial community and an advocate of technology solutions, innovation, and transformation that supports clinical research patients and sites. While many technologies and services bring significant advantages to patients and sites, they’ve also introduced challenges that Viviënne and the SCRS are shining a light on to bring about change.

The clinical trial ecosystem relies on collaboration, and research sites are critical partners that act as the bridge between sponsors, CROs, and patients. Their responsibilities span patient recruitment and retention, study setup and conduct, study drug administration, finance management, device setup, training, data management, data entry, quality, compliance, and more. The bottom line is, studies cannot be completed without them.

It’s critical to gain insight into the needs and challenges of research sites. Medidata has worked closely with sites, patients, and patient advocates for decades (creating the Medidata Patient Insights Program). For sites, Medidata has developed a comprehensive Site Insights Program that includes partnering with the SCRS on the Site Tech Board. This initiative empowers the site voice to be heard and impacts the way technology solutions are designed and implemented.

The result? Best-in-class patient and site-centric solutions that are intuitive, integrated, unified on a single platform with a single log-in, and supported by local-time zone and multi-language support.

Medidata’s SiteTech Board and independent site feedback have provided a deep insight into site needs. Here are examples of key challenges that sites face, how we help, and what else the industry can do.

Technology and Innovation

Sponsors provide sites with a plethora of technologies to support their clinical trial—designed to reduce burdens, remove manual processes, automate complex tasks, and more. While individual solutions can deliver significant benefits, a variety of disparate systems can increase site burden. A site that uses disparate technologies provided by sponsors may need to use twenty+ systems a day. There are also clinical operations portals for training, raising queries, managing invoices, submitting requests, etc. As a result, using five vendors can mean as many as fifty logins.

Disparate systems create challenges as they may not be aligned with each other. An example that Viviënne provided involved two systems: eConsent and IRT (interactive response technology—used for randomization and trial supply management) from two different vendors. The eConsent system asked for a patient screening number, but the IRT system would not proceed unless she could state that the patient had signed an informed consent form. As this was not possible, she reached an impasse, and the vendor support team gave her two options: make up a number (which would be amended later and would involve generating tickets and queries), or generate a paper form. She opted for the paper process to enable them to continue with the visit.

Using disparate eCOA, EDC, eConsent, and patient reimbursement/payment systems leads to inconsistent site and patient experiences, duplicated data entry, extra training sessions, more logins, and extra resources. 

If a site has to use multiple technologies for a study and needs a way to streamline the number of log-ins and interfaces it uses, recent developments have provided a single user interface and dashboard for access to the systems. Medidata is the first company to become a One Home for Sites partner, an IQVIA Technologies solution, launched in June 2024.

Global support is also important for global studies. Local time zone and language support has also been highlighted as an issue and cannot be underestimated. Consider the impact of a site not being able to reach support while a patient is on-site, or a technical issue halting all work. 

Taking this all into account, it’s very easy to understand Viviënne’s ‘escape room’ analogy. 

Financial Management for Sites

The breakdown of site financial management is a critical issue that has faced sites for years. And many are in danger of closing. 

The financial management of site payments from sponsors is the most notable reason. While the issue has been heavily publicized over the last few years, the situation has worsened. In the most recent SCRS Site Landscape Survey, 80% of sites have less than six months of working capital in the bank, most have seen decreased profits, and many report payments that are more than ninety days late. Shockingly, 10% of sites have less than one month of cash flow available. If their next payment is late, they may have to close. As a critically important partner in the clinical trial ecosystem, no sites = no studies.

Financial management, including budgeting, forecasting, and payment management, has been complex and challenging for many years. Empowering finance teams with a clinical trial financial management (CTFM) system can reduce the burden of finance management for patients, sites, CROs, and sponsors. Imagine automated approval processes and workflows, on-time payments, and simplified financial visibility and reporting, to name just a few benefits.

Sites are responsible for the disbursement of payments to patients participating in a clinical trial. The administrative burden of patient payments can be an administrative burden on sites. By using an end-to-end patient payment platform built around a patient portal, along with integrated data flows from EDC and eCOA and a third-party payment processor, sites can focus on what matters most—patient care and efficient trial management.

Decentralized clinical trials (DCTs) have brought another financial element into the equation. SCRS reported as many as 73% of sites that responded to their survey have been approached by sponsors or CROs to participate in a hybrid trial. From experience, sites have found that such studies involve more technology, training, resources, and time. This has a cost element that sponsors have not adequately budgeted for. From a sponsor’s perspective, budgeting and forecasting for a DCT is complex, especially across multiple countries. A budget negotiation solution can help sponsors manage this process with confidence.

Transforming Healthcare with Embedded Clinical Trials

Another element of the escape room experience is the disconnect between clinical research and patient healthcare records, preventing simple access to data found in a patient’s medical history. To make informed medical decisions, patients are required to undergo multiple visits for examinations that they have already completed.

An industry initiative that’s still in progress aims to embed clinical trials with standard healthcare and transform patient and site experiences in clinical research.

One of the ways that Medidata is bringing together the worlds and data of healthcare and clinical research is with Medidata Health Record Connect, a healthcare data interoperability engine for securely and compliantly acquiring, transforming, and exchanging electronic health record (EHR) data. Together with Medidata Rave Companion (a data entry assistant embedded within Rave EDC), this solution simplifies and accelerates data entry by sites by making it possible for Rave EDC forms to be populated with existing EHR data within a few clicks. Forms can be completed up to 90% faster than manually, and transcription errors can be dramatically reduced.

Diversity and Inclusion

Site feedback has shown they would welcome additional support and tools when recruiting patients from diverse populations. Additionally, the 2023 SCRS Site Landscape Survey reported that “all sponsors, CROs, and partners that participated in the survey agreed that the capability of a site to recruit diverse populations does matter regarding site selection.” The Medidata Diversity Program helps all involved to consider diversity before, during, and after the study, to ensure more equitable clinical trials.

The Message from Sites to Sponsors, CROs, and Solution Providers

Key stakeholders in the clinical trial community must sit up and take notice. As partners, research sites are not asking for special treatment. They’re professionals who are the ecosystem’s connection with study participants, building trust and relationships while carrying out all the tasks asked of them to complete a successful study. 

They’re not asking for hand-outs or charity. What they need is an environment that enables them to carry out the work they’re best at.

This is an industry-wide call to action to sponsors and other partners in the industry—research sites need your support. The Medidata platform will go a long way to enable you to support your sites and studies.

If you need help managing the complexities of clinical trial financial management, our CTFM solution will help you meet one of the most urgent challenges your site partners are facing as well.

The time to act is now. Contact us to start the process together.