Thorny budget and contract negotiations between sites and sponsors are the single greatest cause of delays in clinical trials. That’s what staff at large and small sites say, according to a new benchmarking report from ACRP and CenterWatch (Financial and Operating Benchmark Reports for Investigative Sites).
The contract deliberations are a slightly more acute problem at larger sites. For example, while 63% of respondents from large sites cited contract negotiations as the top roadblock, 54% echoed that at small sites. Similarly, 60% of large sites blamed budget negotiation, while 56% had the same complaint at smaller sites (see chart).
Legal expert Molly Huggins JD, MHA, a partner with Huggins & Zuiker, LLP in Savannah, Ga., isn’t surprised by the results. “My guess is that the larger sites generally require more review for their contracts, with more of a negotiation process,” Huggins says. Another difference: Small sites don’t generally have in-house counsel with the time and expertise to effectively and efficiently push back for a better deal.
“There’s no way to sugarcoat it: Lawyers slow things down,” says Erin Zuiker, a partner with Huggins & Zuiker, LLP in Carrboro, N.C. That said, a site that saves a week or two at the front end might end up regretting it when the trial is up and running down the road. “It can come back to bite you later,” she notes.
Learn techniques to improve contract negotiations and avoid clinical trial delays at the ACRP 2017 Meeting & Expo session Battle of the Clinical Trial Agreements: Sites vs. Sponsors. Huggins and Zuiker will discuss critical legal issues that should be addressed in clinical trial agreements and provide suggested language for addressing trickier provisions. Position yourself to meet the needs of all parties in your contracts by understanding site and sponsor requirements. View Program & Schedule
Example: A smaller site might decide it can lean on an old agreement model without really thinking the new situation through. An agreement covering a chart review survey won’t necessarily include the injury risk coverage advised for an interventional study. “You have to look at each contract,” Zuiker says. “Unfortunately, you can’t create a template” and sit back.
There are a number of additional contract variables, including patient privacy and tax laws. While the regulatory requirements between sites and sponsors generally line up in relative synch, privacy issues are far more complex for sites, and contracts should reflect that to protect them. In addition, some sites are tax-exempt where sponsors are not. That difference should also be adequately addressed in any contract, Huggins says.
New: Financial & Operating Benchmark Reports for Investigative Sites
These updated benchmark reports provide critical data for sites to measure their performance against the competition. Compiled from the 2016 CenterWatch-ACRP collaborative survey of small and large sites, these reports provide benchmarking data on site infrastructure, financial performance, operations, staffing, collaborating with Sponsors and CROs, and the impact of technology use.