Choice is the Next Chapter for Clinical Trials
Veeva
ost research sites do not participate in selecting the technology or processes used for clinical trials, as sponsors have traditionally designed protocols and selected tools without investigator feedback. This creates a heavy time and resource burden on site staff managing various systems while working with thousands of patients across hundreds of studies. The impact on site capacity is significant: According to WCG’s 2023 Clinical Research Site Challenges Survey, more than 50% of sites say resourcing issues don’t allow them to open new trials.
Although hybrid trials have become popular, the patient experience too often still lacks choices. For example, participants can have a combination of in-clinic care and virtual activities planned for them but can’t typically select their preferred method.
With advancements in clinical processes and software, it is now possible to give sites and patients more choices. Forward-looking sponsors are asking sites and patients to share feedback in order to achieve more engaged enrollment that leads to high-quality studies. One result of partnering with a research site to solve its core needs has led to the creation of a single sign-on to access systems. This change allows staff to capture the correct data in the right format in the right system on the first attempt, avoiding wasted time and improving the efficiency and quality of the study, which benefits the sponsor.
Enable Sites to Focus on Patients, Not IT
To patients, research sites are the face of clinical trials, providing them with treatments and capturing critical data. With each study seemingly using unique systems, site staff spend significant time managing different processes, requirements, and applications. This leads to challenges when data is captured in various forms, formats, and across disconnected systems, requiring manual data reconciliation.
One way to improve efficiency is to provide sites with fewer log-ins and better collaboration with sponsors. Alisha Garibaldi, CEO of Skylight Health Research, an independently owned clinical site network with locations in Burlington (MA), Harrisburg (PA), and Colorado Springs (CO), says, “Communication and outlining expectations are key. Providing a checklist at the beginning of the start-up process helps sites understand what to expect and allows for proactive study management.”
Standardizing clinical trial processes for collecting and sharing data can drive alignment and quality. If sponsors can provide a standardized approach—a single system with one log-in to execute processes, submit documents, and capture data uniformly—site staff can execute faster, freeing up valuable time to treat patients. Taking this further, sponsors benefit when sites are enabled to use their own preferred technology or application and can use them across studies. This allows site staff to work with familiar tools while sharing information with sponsors through the one system log-in provided, improving collaboration.
“A standardized approach ensures that our team is familiar with the processes and can quickly adapt to new requirements,” adds Garibaldi. “This improves our internal operations and enhances our collaboration with sponsors, as they know what to expect from us.”
Providing sites with clear standards and a choice of using tools, like investigator site files (ISF), patient-reported outcomes (PRO), or other custom applications, saves time and effort and can improve the experience for all stakeholders. While we are in the early stages of this change in the industry and don’t yet have concrete evidence, “We cannot run trials without sites, and happy sites lead to good trials. We must ensure we are partnering well with our clinical trial sites,” says the lead for clinical trial operations technology at one global biopharmaceutical company, highlighting the importance of close collaboration with investigators.
Flexible Tools for Flexible Trial Participation
Delivering patient choice starts with giving patients options to decide how they want to participate in a trial or how to complete specific milestones. The rise of digital applications to execute trial processes makes this approach more realistic. But are sites getting the tools and flexibility to make patient choice a reality?
Unfortunately, technology has traditionally been focused on location. For example, a site may have one application for consenting participants in person and another to use virtually. Sites end up using multiple tools, all designed to be study- and location-specific.
“I come from the times of filling out paper case report forms and faxing them in to validate data on a very archaic program. Today, if a trial is launching with fewer than six different systems, it’s a relief,” says Garibaldi. More than 60% of sites report they use more than 20 applications daily, including clinical trial management systems, wearables, eCOA, and eConsent.
“Everything we do is for a patient or a subject at the end of the day,” said Tina Bowdish, director of cancer research network development and clinical integration at the faith-based, not-for-profit health system AdventHealth. “As an industry, we’re discussing more often how the systems used across different sponsors and all the multiple applications for a trial can be streamlined to make it easier for sites.”
Leveraging technology that enables execution regardless of location reduces the number of applications sites need to learn and use and provides more optionality for patients. One way for sponsors to see quick improvements is to streamline how sites manage patients and data and then unify the captured data on one platform that allows access and workflow completion regardless of location.
Providing a standard patient consent process, whether a patient fills it out at home on a mobile device or at a clinic, offers a solid example which also allows staff to share consent information within the sponsors’ single cloud system in a consistent format. With unified tools that are not location-specific, processes can be standardized for a more efficient and effective trial that simplifies the job for sites and delivers patient choice.
Act on What Patients Tell You
With more than 8,000 studies globally applying mobile healthcare and over 2,900 using wearable devices, the rise of digital solutions in clinical trials has made hybrid and remote studies standard industry approaches. However, the trial protocol still defines the study model and often limits flexibility to conduct processes at a clinic or home. Communication across stakeholders must be prioritized to move toward patient choice, allowing participants to decide the best way to complete a process such as trial consent.
“It’s the press against the flesh, reminding you that we’re all serving a common goal, we’re all human, and we’re all working together,” adds Bowdish. “Ensuring communication is streamlined, getting to the intended audience, and is truly understood is key.”
Northwell Health, a healthcare system with 21 hospitals, is taking steps to ensure two-way communication with trial participants. By surveying patients during enrollment, midtrial, and at the end of the study, Northwell gained insights that allowed them to adapt trial processes and improve the patient experience.
“Many times, it was some simple things, like waiting too long for the radiology portion of their site visit. Having this data helps us to better leverage the patient voice and makes us realize we must do better on patient choice,” says Dr. Christina Brennan, Northwell senior vice president of clinical research.
Always Choose Standardized and Simpler Processes
As an industry, we are all working toward the same goal: helping to save patient lives. Site and patient choice are a trend that is gaining significant momentum, and biopharmaceutical companies are taking action. Many are standardizing their work with research sites for consistent protocols and tools, leveraging solutions on a single platform for seamless processes and information exchange. These technologies enable sites to work on their preferred systems, whether that’s an eRegulatory system, a custom application, or an Excel workbook, improving efficiency.
For patients, having the flexibility to choose when to go into a clinic or attend a virtual appointment can significantly improve their experience, which keeps them in the trial while providing more efficient access to treatments and medicines. This frees up valuable time to capture patient feedback, which helps study teams refine their approaches to better meet patient needs.
Standardized technology is helping industry to make site and patient choice a reality in clinical trials. By considering patient needs and site preferences, sponsors can improve patient retention, reduce costs, and deliver better experiences for all stakeholders.
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