You can improve your chances of being selected
You can improve your chances of being selected
Make circumstances work for you
While it will take a commitment by sponsors and the entire clinical trial industry to make major changes that will improve trial enrollment and study quality, experts say there are some things that individual sites can do to improve their own quality and desirability as a clinical trial site.
One of the first steps is to collect data on your own site’s performance, experts suggest.
"I think any business needs to be familiar with what its performance is, and that’s not something that has been paid attention to a lot by enough people in the clinical trials industry," says Adam R. Chasse, director of patient and site management services for Quintiles of Morrisville, NC.
"No matter what your product is, you should make sure you have a feel for how effectively you produce that product and make sure you’re giving much due regard to quality," he says.
By performing well and documenting this performance, a clinical trial site can build both a reputation and a marketing tool, says Louis C. Kirby, MD, medical director of Pivotal Research Centers in Peoria, AZ.
Kirby and Chasse offer these additional suggestions on how to make a site a top pick by sponsors:
• Develop personal relationships with sponsors.
"The short answer is that people currently give clinical trials to people they like," Kirby says. "I’m on the phone constantly with pharmaceutical companies. I go to investigator meetings, and I spend time with pharmaceutical staff getting to know them."
Kirby says he spends time finding out what pharmaceutical staff like and dislike and what their fears and weaknesses are. "If I’m working with a new company, I’ll say, Let me give your staff a talk about this and what works and what doesn’t. I offer to be a resource to them."
Any site that is starting out should talk with sponsors, making personal communication.
• Know your own strengths and weaknesses.
"Collect your own numbers and present these to sponsors," Chasse suggests. "What sites that are doing all these things well need to do is know how to really sell that success."
The clinical trial industry is competitive, so they need to know how to make themselves stand out to Quintiles or to whomever, he says.
"Then when they get in the door and perform well, they should make sure the company remembers that they performed well, and that needs to be part of the business strategy," Chasse notes.
But it’s also important to be able to describe a problem-solving or process improvement strategy, he says.
"What would impress us is for a site to be able to describe to us how it would go about fixing a problem if it happened," Chasse continues. "If the enrollment fell behind, or if the monitor noticed on three visits that certain paperwork is not in order, then does the site have a system where someone can step in and fix it?"
Also, another question to consider is how qualified are staff to perform the study, he says.
"Are we going to be surprised by something we find in the audit or something the FDA finds later down the road?" Chasse asks.
"A good site has standard operating procedures in place, and everybody is enforcing those SOPs," he explains. "But if your acknowledgement procedure is just that everyone has to read them and never look at them again, then that’s not an adequate quality assurance program."
• Contact referral sources.
"Sometimes, universities have a population that’s unique," Kirby says.
Referral centers go there for certain groups of patients, so it’s a good idea to identify those types of opportunities, find universities, contact them, and let them know you have a patient population that’s important to their development and that you have a site that can handle a clinical trial, he adds.
"You get on the phone and talk about what you have and what you can do, because if they don’t know you’re out there, the phone is not going to ring," Kirby notes. "It’s amazing how many doctors don’t put in the time it takes in order to develop the relationships."
While it will take a commitment by sponsors and the entire clinical trial industry to make major changes that will improve trial enrollment and study quality, experts say there are some things that individual sites can do to improve their own quality and desirability as a clinical trial site.Subscribe Now for Access
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