Identifying the money pits in conducting clinical trials
Identifying the money pits in conducting clinical trials
Keep these in mind when negotiating budgets
As part of the discussion of how budgets can influence subject enrollment and retention, Jeffrey Adelglass, MD, CEO, Research Across America, Dallas, TX, ran through his Top 10 list of budget busters1 — David Letterman style.
#10: Excessive or inefficient monitoring. Adelglass estimates that each additional day of monitoring costs a site $1,990-4,020 in space, time, and resources. Here's how Adelglass breaks it down: $1,500-3,500 in lost revenue; $50 for coordinator salary; $15-30 for copies; $20 for space; $10 for internet access; $200 for a regulatory specialist.
#9: Sponsor tools that really aren't much help. Too often these tools are poorly targeted and generic, and high-tech tools can be slow or difficult to use — and even harder to support. "E-diaries," Adelglass claims, "fail 50% of the time, which can translate into losses approaching $70,000 per year."
#8: Sneaky hidden costs. Increasing regulatory compliance requirements, research-specific insurance, and a lack of computer/software standardization across pharma are just a few examples of hidden budgetary challenges for sites. Sites are also challenged by investigator meetings that take time away from revenue-producing activities; ongoing training needs — and the cost of replacing coordinators when they're poached by sponsors; and overhead that has been rising 6% annually while study budgets have stayed the same.
#7: Ambiguous, mystery contracts. "Who can budget for a contract that ultimately has 10 amendments?" Adelglass asks.
#6: Dropped, canceled, and closed studies. According to Adelglass, when studies are dropped, canceled, or closed, there's no concession for lost time, revenue, and missed opportunities, or the staffing requirements put in place to meet sponsor expectations.
#5: Bad protocols. In Adelglass's experience, many protocols are poorly written with vaguely defined endpoints. In some cases, it's difficult to determine from the protocol whether you can meet study milestones.
#4: Eating the advertising. Advertising budgets may simply be unrealistic. Adelglass's experience in Dallas: 20 radio spots over seven days with no guaranteed placement costs $3,000; a 2" × 5" newspaper column for one weekday costs $2,500; 20 television spots (15 seconds) over one week costs $3,000.
#3: Average study budgets. Real costs and actual costs rarely align. According to Adelglass, outsourced procedures, procedures that are lumped together by the sponsor, and patients lost to adverse events are rarely taken into account in the budgeting process.
#2: Unrealistic sponsor expectations. Will your study require a sub-zero fridge? If it does, Adelglass advises allocating $65,000 for that fridge and the compliance training for staff on how (and how not) to use it. Will your study need a dedicated coordinator? What about a 24-hour call center?
Screen failures, however, may be one of the larger budget eaters. "Ninety-nine percent of sponsors limit payment for screen failures," says Adelglass. "Sites simply aren't reimbursed for the manpower and time to meet enrollment goals."
#1: Slow pays and no pays. Sponsor's payment processes represent an area that needs to be re-examined. "PIs often are small businesses," says Adelglass. "Sometimes payments aren't made till the books are pulled and monitored. And some sponsors won't come and pull the books. We've even been in the position of being owed money by a sponsor who then filed bankruptcy," adds Adelglass.
Adelglass advises that many of these challenges can be addressed with increased communication and a commitment to partnering. "No one likes surprises," he adds. "With communication, there comes trust. With trust, both sides are more likely to be successful."
Reference
- Investigator budgets: Impact on patient enrollment and retention. Presented at the 44th Annual Meeting of the Drug Information Association; Boston, MA; June 23, 2008.
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