Use Data and Details to Convince Site Leadership to Add Staff
Sites can add depth to their research teams by creating specialized positions and potentially free up existing staff to take on more trials. The challenge is in site managers or directors convincing site leadership — typically vice presidents — that the gains outweigh the costs.
Making the case to budget-conscious site leaders requires strong data and a compelling argument that clearly shows the return on investment, one research director says.
Positions such as regulatory staff, data specialists, research pharmacists and study startup/recruitment specialists can add capabilities and flexibility to a site that is struggling to keep up with its trials, said Suzanne Rose, director of Stamford Hospital’s Office of Research. But that’s not always a convincing sales pitch.
“It’s hard to justify bringing in positions that don’t always have a dollar sign attached to them. Try to think outside the box with your organization,” Rose advised attendees at the recent Association of Clinical Research Professionals annual conference. “Really find that way you can identify with your leadership on different types of positions to say, ‘this position is really needed for compliance reasons, this position we can tie back to revenue directly or indirectly,’” she said.
To propose adding a regulatory specialist to the staff, for instance, emphasize that such a position increases regulatory compliance both with the IRB and the FDA and note that such staff can free up other staff — especially CRCs — to focus on accelerating trial startup and improving enrollment, Rose said. And be sure to let leadership know — especially if they want to be able to link the hire to site revenue — that regulatory personnel can reduce about 25 percent of CRC burdens.
“If you say … coordinators can then take on another study, another two studies because they have regulatory support, then you can say that there’s revenue that comes in … that you can tie back to the regulatory personnel,” she said.
New data specialists/managers also can relieve the burden on CRCs. Stamford uses them to promptly collect and upload data, maintain the clinical trial management system and develop reports, forms and templates as necessary. This role can serve as a multidepartment position as well, supporting onsite visits and remote monitoring, pitching in as a backup research coordinator and helping to process and ship research specimens.
Always include this position in trial budgets, Rose advised. In her experience, sponsors will reimburse sites about 80 percent of the time, understanding the benefits of having data specialists on staff.
Stamford employs study startup/patient recruitment specialists for a variety of tasks, including completing feasibility questionnaires and leading site initiation visits, finding promising trials, reviewing/presenting protocols and serving as the first point of contact between the research team and sponsors/CROs. They’re also responsible for keeping detailed records of startup timelines, preselecting potential participants and managing phone calls as well as supporting the development and upkeep of the site’s social media advertisements.
The selling points for this position, she said, are that a dedicated recruiting manager can increase enrollment by 25 percent on average, which is particularly compelling for sites struggling to sign up participants. Rose noted that 20 to 25 percent of trials close because they fail to meet enrollment goals. One-third of a CRC’s time can be tied up by recruitment, and study startup can take 10 to 15 percent of their time away from enrollment and patients.
Adding a site pharmacist also takes several tasks off CRCs’ plates, especially investigational drug storage and inventory. Stamford uses their pharmacists to maintain the pharmacy binder, instruct staff on all of the trial drugs’ aspects, help avoid drug compliance problems and even assist with regulatory tasks when needed, including checking informed consent compliance and managing a checklist for trial eligibility.
The pharmacist position also should be included in the trial budget. Justify it by outlining any drug compliance issues the hire can help prevent, including lost drugs, temperature excursions and incorrect dosing that can cost sites money or, worse, harm patients. Rose noted that problems with investigational drugs can cost sites hundreds of thousands of dollars over time.
In addition to presenting the benefits of a new hire, it’s important to outline the ramifications of not having a position filled, Sandy Smith, senior vice president for clinical solutions and strategic partnerships at WCG, told CenterWatch Weekly. Use measurable details and include a commercial angle; for example, if not having certain personnel would impact data entry timelines, share how many days late data entry would be and how it would affect the site’s ability to open more trials.
“Be as specific as possible. General statements such as ‘we need more staff’ do not adequately explain the business need, nor do they portray the effect on operational performance both quantitative and qualitative,” Smith said.