Workflow Optimization Moves to Clinical Trials

Many industries have benefited from workflow technology, as they are readily available in many off-the-shelf forms. However, some sponsors and many study sites still use old-fashioned methodologies, such as excel spreadsheets, trackers, and paper forms to manage the clinical trial recruitment and screening process and provide feedback on prescreen failure reasons. In this interview, Ralph Passarella, CEO and Co-Founder, and Michael Lin, Executive Chairman and Co-Founder of Reify Health, will discuss how workflow optimization technology adapts to address clinical trial recruitment issues.

Moe Alsumidaie: Why is it essential to provide recruitment workflow support to study sites?

Ralph Passarella: While $4B a year is spent on technologies that support clinical trials, relatively little of that investment is spent on solutions specifically designed to help the frontline healthcare staff coordinate research and trial-related care for patients. Without the proper tools to perform the critical tasks of recruiting and enrolling patients, sites are left to manually do this work, leading to significant inefficiencies and delays. 90% of clinical trials experience a delay, and those delays can average a month or more. Knowing the impact clinical trials have on patients in need, Reify wanted to create a platform that both sites and sponsors can leverage to address the efficiency gaps in recruitment and enrollment. The industry needed a reliable, connected platform to manage patients and trial-wide enrollment. Our technology helps clinical sites quickly track, manage, and complete patient recruitment and enrollment and streamline communication with sponsors. The technology organizes the subject journey from prescreening through enrollment and facilitates data transfer (i.e., screen fail reasons) in secure format to sponsors. This not only improves enrollment outcomes but also supports the identification of bottlenecks in recruitment and protocol optimization.

MA: What challenges have you seen in the clinical trials space over the years, and how can it improve?

RP: Trial timelines need to get shorter and become more predictable. As I mentioned before, 90 percent of trials face some delay. Eighty percent of all clinical trials either fail to enroll enough patients or fail to enroll patients on time. Despite all of the advances made in drug development—from precision medicine to real-world evidence—significant pieces of the pipeline remain painfully slow, especially recruitment and enrollment. 

At Reify, we believe we haven’t seen a meaningful improvement in recruitment and enrollment because we, as an industry, haven’t focused enough on solving challenges for research sites—the true engines of clinical research. The healthcare staff at these sites—research coordinators, nurses, investigators, etc.—are responsible for an immense amount of work identifying, reaching out to, educating, managing, and caring for the patients engaging in clinical research. Yet, historically, this group has been forced to rely on antiquated and manual processes and tools to do that work.

By focusing on the workflows of research site staff, we built a platform that substantially reduces their workload and provides sponsors with the information they could not previously access. This approach—starting from the site staff workflow and connecting it to sponsors—is how we’re driving faster (6 weeks faster than plan, on average) and more efficient (16% more patients per month per site) enrollment for half of the top-20 global biopharmaceutical companies. 

MA: How has the current environment impacted the clinical trials space and your approach?

RP: The COVID pandemic is (1) drawing more attention and scrutiny from the public with regards to the efficiency and speed of trials; (2) pushing the industry to adopt new ways of working to accelerate COVID vaccine and therapeutic development; and (3) forcing the industry to develop new processes to run non-COVID trials safely during a pandemic.

On the first point, Reify is built on the idea that there are parts of the clinical trial process that can run substantially faster—namely, recruitment and enrollment—while not sacrificing safety and efficacy. If we invest heavily in those pressure points, as we are, we can get safe and effective therapies to patients faster.

On the latter points, we’ve also seen some incredible work being done by sites and sponsors to build entirely new approaches to running clinical trials for COVID, such as fully mobile clinical trials wherein a site can be deployed and set up anywhere in the country within 48 hours. This work’s immense complexity makes the traditional paper-based approaches to connecting and engaging with patients a non-starter. Instead, StudyTeam is being used in such trials to digitize, simplify, and accelerate the process.

MA: How could a solution like this work for sites? How about sponsors?

Michael Lin: For sites, we’ve replaced paper or Excel-based tools with a cloud-based solution that’s built around their workflows. Additionally—and this is critical—StudyTeam for Sites is not another place for sites to log in and input recruitment and enrollment information for a sponsor; it replaces those systems with one platform for managing recruitment workflows that can also communicate with all of their sponsors securely and in real-time. 

For sponsors, they can view the real-time insights and gain valuable recruitment and enrollment insights they have always struggled to access. This allows them to see enrollment trends across the entire trial and make rapid decisions that drive more efficient enrollment. For example, they’re able to see which inclusion and exclusion criteria cause the most prescreen and screen failures to inform consideration for protocol amendment. We are connecting sponsors and CROs to the workflow of their research site partners around the world.

Finally, and perhaps most importantly, sites can automatically share recruitment progress with sponsors through StudyTeam, virtually eliminating the need for sponsors to ask every site for recruitment updates every week. Sites using StudyTeam spend significantly less time documenting and sharing information with their sponsor and CRO partners and more time recruiting and enrolling patients.

MA: Where do you see the clinical trials space evolving a few years down the line?

RP: With the increased attention the clinical trials space has received in the last year, there’s a genuine possibility we see significant progress in the next few years. One area we’re particularly bullish about is the idea that research can operate more like a functioning ecosystem where each stakeholder group is equally aware of and invested in participation. 

Most patients today are either unaware of clinical research as a treatment option, don’t know how to get involved, or are hesitant to participate. On the flip side, many physicians and providers want to join the clinical research community but are turned off by its perceived complexity, startup costs, etc. By connecting and empowering these stakeholders with information, tools, and other resources, we see clinical research becoming a more commonplace treatment option in the broader healthcare system.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.