An issue causing growing frustration among clinical trial executives are vendors unable or unwilling to share metrics with sponsors.
While careful vendor selection is more critical than ever because of ICH E6, sponsors are increasingly frustrated with a lack of metrics to help gauge how likely it is that an operational problem may arise with a vendor.
“You need information to be able to help you understand what has happened in the past, how often has it happened, how bad the impact is when it does happen,” says Linda Sullivan, co-founder and executive director of Metrics Champion Consortium (MCC).
Many vendors have standard reports to measure what they consider key performance indicators, and sponsors should review those reports and determine if they meet the trial’s needs. But sponsors and CROs need to share information with vendors too.
“I think where people run into problems is when they don’t share enough information with the vendors about what’s going to happen in their program,” says Sullivan. “Often, problems in the design of the study could be avoided if vendors were brought in earlier.”
Problems with certain types of vendors can be more critical than others, according to Jill Petro, a trial manager at Janssen R&D.
Although translation, laboratory and interactive voice/web response vendors comprise a small portion of the overall clinical research enterprise, mistakes in those areas can cause critical delays, Petro says, so it’s important to be particularly vigilant.
“It’s easy to say you’re trying to pick for the best quality,” she says, “but there are a lot of things that feed into quality.” Petro recommends using a checklist to make sure all considerations are covered.
For translation vendors specifically, Petro advises asking what portion of the staff is full-time (to gauge the likelihood of high turnover), and about the minimum training requirements for staff (to gauge the likelihood of errors).
Another important component is the vendor’s internal quality standards, such as requiring double-checks for each document, and whether those additional quality checks come at an extra charge. Finally, it’s best to ask about the vendor’s policy on a rush turnaround, in case of a protocol change later down the line.
For central laboratories, Petro recommends asking about such factors as the lab’s ability to perform all of the tests the trial requires, how long it takes to ship kits to sites and how quickly it can deliver results. She also advises asking about the company’s ability to transfer data to the sponsor and whether there is an additional charge for doing do.
Finally, for interactive voice services, sponsors should be aware of the vendor’s experience with the type of trial being conducted, such as a randomization v. stratification trial design. Like the other vendors, the vendor should be able to transfer data and should be comfortable with the various countries/languages included in the study.
“It all comes back to that risk base and oversight” outlined in ICH E6, Petro says. “Every company is looking for technology solutions [to] be able to tell FDA inspectors that they are doing their oversight.”