Trial sites can attract more sponsors by learning 3 words: change, change, change

Put site performance info in electronic database

One of the hottest topics in clinical trial research these days is site selection, and the biggest obstacle to matching sites and sponsors is that people won't let go of the old ways, an expert says.

"There's resistance to change, and until some sort of burning platform appears that forces you to take action, companies don't change," says Douglas E. May, MS, a solution partner in life sciences practices for BusinessEdge Solutions of East Brunswick, NJ.

"To me it's perfectly reasonable that you would really examine your sites to make sure you get the ones that have experience as successful enrollers of patients and the ones that have experience in meeting deadlines," May says.

Instead, the traditional way of finding sites has resulted in sites that enroll zero patients being chosen repeatedly for reasons other than their efficiency, May says.

With the Lean/Six Sigma philosophy spreading throughout the research industry, the traditional way is giving way to change, and clinical trial sites can position themselves for the new trend by changing themselves.

"Clinical trial sites need to undertake methods to optimize patient recruitment or make it known to sponsors that they're willing to be early reviewers of protocols to assess how well it could be executed," May suggests. "Often sites are not involved, and it may be that the sponsor never thinks about involving them or thinks they wouldn't be willing to do it."

So if sites put a high priority on being early reviewers of protocols, then they'll be able to handle studies more efficiently and they'll be asked to be involved with more studies, May says.

Likewise, sponsors need to change the traditional practice of selecting sites based on what they perceive as opinion leaders, May says.

"I believe it's important to have influential physicians getting excited about the coming of a new product in their therapeutic area, but it has to be balanced because, at the end of the day, you have a business to run," May says. "If you don't hit the clinical trial deadline, the product will be delayed in coming to market, and that will hurt its marketability."

So, it makes no sense to continue using low enrolling sites, he adds.

"Some companies we're working with are waking up to that fact and are putting together tools that will help them be much more selective in choosing sites," May says.

Sponsors can easily find out this information by reviewing sites' past performances and by checking with on-line sources, such as clinicaltrials.gov to see where some of the industry leaders are initiating trials, May suggests.

"If Eli Lilly is going to one site time and time again, then chances are it's a good site, and you may want to get a study placed there, as well," May says.

Pharmaceutical companies already have site and investigator performance information that they've collected, but the information is not captured in a database that can easily be analyzed, May notes.

"There is very important site information captured in site-monitoring reports," May says. "Those are kept as documents rather than data, so it's not available to be analyzed to help you make better site selection decisions."

The solution would be to make the monitoring reports electronic so sponsors could easily see each site's performance on protocol deviations, violations, good clinical practice, and participant enrollment, May says.

"It would be simple to use electronic forms for monitoring reports or to routinely put these into investigator site databases so that you could use these in the future," May says.