Applied Clinical Trials
Real-life examples of how a clinical trial management system impacted work-life for the better at five sites.
Clinical trial research sites are at the ground level of clinical research, and are tasked with a myriad of responsibilities. First and foremost, clinical research sites execute trial protocols while providing the best patient care and experience, ensuring patient safety and gathering and providing accurate clinical data. Typically, sites are conducting multiple concurrent trials, in various stages, from recruitment to trial close. Simultaneous recruitment of patients meeting different study criteria is necessary. Patient visits must be scheduled and take place within time windows.
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Regulatory compliance, IRB requirements, meeting milestones, and data gathering and reporting must occur. And trial finances, including sponsor invoices, provider payments, and patient stipends must be managed. Added to these responsibilities are the operational and financial aspects of running and managing a business.
Patient recruitment and site performance continue to be challenges, and the geographical scope and complexity of trials continues to increase.1 The economic environment is driving increased sponsor focus on cost and timelines, and is resulting in delays and cancellation of trials.2 This is directly impacting research sites. As a result, tools that facilitate communication, address workflow challenges, improve economic return, and provide the metrics to demonstrate performance are becoming increasingly important.
A clinical trial management system (CTMS) favorably impacts site efficiency and productivity by centralizing information—including searchable patient databases and trial protocols—providing recruitment and screening tools, automating scheduling, managing finances, and providing the reporting and metrics needed for business oversight and growth. The result is simplified workflow, easier recruitment, optimum use of advertising funds, proactive management of finances, more productive staff, and ready availability of proof points and metrics for sponsors.
Clinical Research Advantage, a site management organization with multiple sites and many concurrent trials, has provided research services for over 18 years. Eric Levie, chief technology officer, says, "As our business continued to grow, we wanted the ability to manage the scheduling and financial aspects of patient activity, and also use the information for staffing purposes and overall business financial oversight."
Rochester Clinical Research has conducted more than 450 clinical trials since 1994. A single site research organization, Rochester Clinical Research implemented the current CTMS due to the frustration of a disjointed approach. President and Chief Executive Officer Pat Larrabee explains, "We had a system with a partial database and some financials, but we used paper and Excel spreadsheets for scheduling. It was a multistep process. Our new CTMS has improved recruitment, optimized scheduling workflow, and has provided a better handle on metrics and finances."
DCOL Center for Clinical Research, a dedicated research center and a department of the multispecialty clinic, Diagnostic Clinic of Longview, PA, has been conducting trials since 2005. DCOL implemented a CTMS for the financials. "We needed a better handle on things, and needed to make sure things weren't falling through the cracks," states Sue Faul, Contracts and Financial Administration.
Sterling Clinical Research was formed as an independent research center in 1999 and now conducts many concurrent trials at three locations. With the growth, Sterling implemented a CTMS to keep everything situated. "We like the idea of having everything in one place," says Betsy Harris, marketing/database manager. "Our CTMS has streamlined operations and provides the metrics to demonstrate success as a clinical research site."
Benchmark Research conducts clinical studies at six different sites, and at any one time different sites can be running the same study. Charlie Ciarlo, customer service recruitment manager at Benchmark's recruitment center, explained, "We implemented a CTMS because we needed more on reports and budgeting, and wanted a solution that would manage all aspects of clinical trials."
So how exactly does a CTMS help clinical research sites face challenges and improve performance?
Subject recruitment continues to be an area of concern for clinical trials. Industry experts estimate that a large percentage of trials miss timelines due to not achieving the number of needed subjects.1 Failure in recruiting and retaining subjects has the greatest impact on trial costs, delays, and failures. Sites that optimize subject recruitment and retention will be more successful in the long term.3 Maximizing the use of existing patient databases and optimizing advertising return can help.
At Rochester Clinical Research, before implementing a CTMS, recruitment was not efficient. "We kept track of volunteers and patients in books specific to a type of study. We would photocopy information, and put it in the right book. It was difficult and time-consuming to sort through the population of patients. People in books are not easy to target and reach," says Larrabee. "We knew that we needed a patient database, and that it would be a fantastic resource. We wanted one that was searchable, with the ability to sort by conditions and demographics. With a CTMS, we target and manage our patient/volunteer population. All aspects of recruiting have changed. And, we are better and quicker at identifying patients for studies."
To achieve these gains, a CTMS must have a patient database that can be sorted and is able to create targeted call lists. For studies that are difficult to fill, focused work with the database and call lists can fill those studies quickly. The site has also created a community within the database, with newsletters, email blasts, and advisory boards.
Sterling had "so many spreadsheets," states Harris. Whenever a patient called, a phone screening form was used to obtain all information, and when staff had time, the information would be entered into a database. "With a CTMS, we've eliminated paper forms, and enter all information into the CTMS in real-time. We've eliminated duplicate patient data entry. With the patient database, as soon as we get the green light to enroll, we're ready to start. This is largely due to the ease of doing searches. In fact, some studies are limiting us due to enrolling patients so quickly."
At Benchmark, many aspects of recruiting workflow have improved. "Before, we had to fax sites in order to get the data needed to prescreen and recruit," states Ciarlo. "Now all the information is in the system. We have call lists, and manage reminder calls, emails, and notes history, directly from the system, saving a great deal of time."
Rochester Clinical Research is seeing the benefits of tracking return on advertising. Tracking the return on advertising dollars is critical for optimizing recruitment, spending funds wisely, and maximizing sponsor funding. At Rochester, advertising ROI used to be tracked with manual ticks on a piece of paper. As a result, accuracy of the information relied on recall and how busy people were.
"Advertising is very expensive, and media is in a huge transition—we need to know how effective our advertising dollars are," explains Larrabee. He adds, "10 years ago an ad in the paper might generate 100 calls. Now it might be three. We need to know how to spend our limited budget dollars."
A key CTMS feature is the ability to analyze advertising metrics somewhat automatically. "We know where a call is coming from. The database is much more powerful than expected. It's changed how we recruit and where we put our advertising dollars. We know what's working and what's not." Efficient use of recruitment dollars has helped the site get to goals sooner. And, the metrics are available to negotiate with sponsors for additional advertising funds.
With multiple studies, different protocols, specialized needs, and sometimes multiple locations, study scheduling, staffing, and tracking can become daunting, and performance metrics difficult to obtain. Studies show that about half of sites will underperform. Even sponsors admit that they are not certain which sites will meet objectives and which will fail.4 The ability for sites to self-monitor performance and have the metrics to use in discussions with sponsors leads to improved site and overall trial performance.
At Clinical Research Advantage, the CTMS provides the ability to build study windows and automatically schedule patients. As soon as any site knows a patient is interested, information can be entered into the database in real-time, so call centers can schedule immediately. Previously this was done with paper calendars and visit windows were calculated manually by the coordinator. Now, calendars are shared across sites and site managers have a view of what is going on.
Previously, Rochester Clinical Research had one gigantic appointment book, and only one person could schedule at a time. Paper scheduling was very frustrating and took a long time. With a CTMS, protocols and visit windows for every study are available to multiple people. "Electronic scheduling has made life easier for so many people," says Larrabee. Now, as soon as someone qualifies, he or she can be scheduled for their first appointment immediately. If something is changed, there is a record of who has changed it. An overview of visits provides real-time data and highlights when patients need to be scheduled to stay within the visit window.
At Benchmark, since all locations are in the system, the central office is able to enter the database and have immediate access to information. Appointments can be scheduled without calling a location to get all the patient information. "Before, we had to fax sites in order to get the data needed to prescreen and recruit," states Ciarlo. "Now we can just click a button and see what we need to see. Everything is faster. We can get work done more quickly, and don't need overtime."
Levie is seeing an added benefit. "Before we had our CTMS it was difficult to know which visits were going on at which sites, and managing labor was difficult. Other than paper logs, it was hard to visualize how much business there was at each site without calling or faxing. This took a great deal of time," explains Levie, "and it was just as time intensive to get an overview of where we were with studies and patient loads. We used to have to call constantly, and even then, it was difficult to get up-to-date information."
Now, all information is available in real time and accessible from a central location. A study dashboard shows the status of each study and how well each site is doing on a particular study, as well as overall, and the forecasting report makes workload planning easier. "The CTMS needed to provide these features," says Levie, adding, "we can now be proactive and shift labor among sites, only hiring temporary help when necessary—this is helping save costs."
Larrabee is seeing a similar improvement in workload planning, but in a single site environment. Prior to the CTMS, there was no overall and forward view of the schedule and no way to get data on upcoming appointments. This made it difficult to minimize scheduling conflicts, plan workload, and proactively adjust staffing. Also, without past study information, data for workload projections was not available. Larrabee comments that "now we don't need to rely on a 'gut' feel to assign studies. We're able to project what's needed and make assignments based on the workload data." When patients are scheduled, availability of staff and resources are assured.
A CTMS has also facilitated data collection and has improved study start-up time. Mervyn Weerasinghe, MD, principal investigator, comments that "it's much easier to get things done in time for study start-up. All documents can be turned around quickly and usually within 48 hours or less." Feasibility analysis is a key step in assessing whether a site can execute the trial with available resources, and if not, what is needed.5 A database of historical and accurate information is key for medical and clinical directors who have responsibility for preparing the analysis.
Levie is also seeing the advantages of a searchable database. Before "we had to dig through charts." He notes, "We've definitely saved time with a CTMS, especially for studies similar in nature." With a solid database, the regulatory department has become more efficient. It's easier to pull data for IRB reporting, and information is available without having to call the coordinator. Also, since data is maintained electronically, it's quicker to get accurate info.
Coordinators also are more efficient. Previously, they spent a great deal of time gathering data for regulatory purposes, questionnaires, and stipend processing. Now, information is easily available, so coordinators can do what they do best: work with the patients and follow the protocols given. Having a CTMS minimizes the amount of time spent on nonpatient related activities.
Financial management and reporting are streamlined with a CTMS. Without it, it is difficult for sites to know where study finances and overall finances stand. And the day-to-day operational aspects of managing finances are cumbersome. With postponements and delays of trials and an increase in uncollectible receivables, it has become increasingly important for sites to proactively manage finances and improve the ability to link payments received to studies.2
Previously, hundreds of spreadsheets were used at Clinical Research Advantage, and it took a great deal of time to gather the information needed for payments. All financial activity was manual. Now, internal controls are in place, and with a few clicks, the central office can take care of stipend payments. Says Levie, "With the overview of visit windows, we're able to budget better, and with real-time data, we have an accurate snapshot of the profitability of a study. Our CTMS is a great tool to forecast cash flows and revenues, and to track payments to providers. It's much simpler when the data is in a central location, rather than hundreds of spreadsheets, and we've just implemented QuickBooks integration to automate our check processing flow."
Reporting is more efficient, more accurate, and the information needed for internal business management and external communication is available. Having a CTMS has improved communication among all departments—finance, marketing, recruitment, training, operations—and has combined collectively all of the departments' information through access to one centralized database. Before their existing CTMS, Rochester Clinical Research "didn't really know where finances stood until several weeks after the close of the month, and even then it was time-consuming to compile the information and ensure its accuracy," says Larrabee. "Now, at 11:00, we can tell what kind of day we're having, not weeks or months later."
In addition, a CTMS enables more targeted goals for employees. "Because of the comprehensive metrics, we have a much better idea of which studies are profitable and which will have a better yield. We can prepare a budget more quickly than before because we have the actual costs. Also, we can look at past months and trends when choosing studies, and we know which studies we can do well—and have the metrics to prove it," Larrabee notes.
"Before implementing a CTMS, we didn't really know the volume of work. We had a ballpark figure, but no specifics," Faul explains. After implementing a CTMS, DCOL is able to track the number of visits, average intake per visit, and dollars to break even, down to the visit level, and can also set break-even volume goals for staff. Faul adds, "We have a complete study budget tracking tool—everything is in sight—we know what we've done, what we've been paid for, and what we've paid to providers and patients." This was very difficult to do before.
Now every time a payment comes in, DCOL does a "mini audit." "If there's something we haven't been paid for, we can follow up, and shorten the timeline for sponsor payment. It's also easier to tie checks that come in to a particular study," says Faul. DCOL tracks everything from advertising to one-time negotiated fees, and regularly compares actual to budget. Faul adds, "We also track vendor statements within the CTMS. This is particularly important when procedures aren't done on site. We're proactive about paying people."
Implementing any new IT system can be daunting and goes beyond the technology change. Processes and workflow need to change to gain the benefits, and old habits must change. Transitioning from a different IT system requires data export into the new system. When transitioning from manual methods and Excel spreadsheets sites can decide to switch to the CTMS only for all new studies moving forward, or enter data from all existing open studies. Either way, it's important to train staff, understand how it integrates with policies and procedures, and modify processes and workflow as needed. Although immediate benefits can be derived, a full transition can take months.
At Clinical Research Advantage, Ange-Lisa Ashbeck, certified clinical research coordinator and director of training states, "We went from employees thinking they weren't going to have to go through the pain of transition, to an acceptance that now they don't know what to do without it."
At Sterling, Harris notes that "the training of our staff was probably the most difficult part of the transition. We separated staff and trained them only on things they would do...this was less overwhelming."
To facilitate its adoption and use, Rochester Clinical Research also separated initial task responsibilities, assigning training and responsibilities by job function, for example, recruitment, finances, and regulatory. People can be afraid to give up paper, and have a natural fear of how the new technology will work and whether it will do what it promises.
Rochester also chose a set number of new studies to start the cross-over and implementation. Inputting data, developing habits, and learning by trial and error were important for successful CTMS adoption at DCOL. "The more we use the system, the more reliable the data becomes," Faul states: "What's nice is that the data is there, not in someone's head, and we're building history. We have a stable record of what's happened that carries over with time."
A phased transition and breakdown of responsibilities can be very successful in maximizing benefits derived from a CTMS, as well as the recognition that there will be an ongoing evolution of its use over time.
These examples show how a comprehensive CTMS can improve the efficiency and productivity at different kinds of sites. This is achieved by centralizing information, enabling real-time access from multiple locations, providing patient databases and recruitment tools, automating workflow, managing finances, and providing the data and reporting needed for business oversight and growth.
A CTMS needs to be able to handle all aspects of clinical trial management so that sites can focus on clinical trial execution and managing the business. The right CTMS improves patient recruitment, optimizes return on investment, enables more efficient execution of trials, improves communication, and provides the metrics needed to optimize profitability. And, a CTMS sets a strong base for ongoing improvements in communication and collaboration across the research environment.
Levie sums it up with "We have a better vision of the business. We can see what's going on in real-time. We know what we can handle, and don't take on too much or too little. We have the proof points and the data we need for sponsors. We use the tool to be more efficient overall. It helps us be the best we can for patients and sponsors."
Maria Durkin is vice president and director of marketing and operations for Bio-Optronics, 1870 South Winton Road, Suite 10, Rochester, NY 14618, email: firstname.lastname@example.org
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