Here are suggestions for improving CR efficiency, speed, and process
Here are suggestions for improving CR efficiency, speed, and process
Think of practical, low-cost solutions
Several experts on what works and what doesn't in the clinical research (CR) process say there are ways individual research institutions and sites can improve their own site performance and trial speed.
Here are their suggestions on how to improve clinical trial (CT) efficiency and why it's so important:
1. Hold simultaneous study review meetings.
Research institutions sometimes have multiple review bodies that can slow down the initiation process of a clinical trial, says David M. Dilts, PhD, MBA, director of clinical research for the Knight Cancer Institute and professor of health care management at the Oregon Health and Science University in Portland, OR.
"A common problem that happens involves the number of scientific reviews that have to take place," Dilts says. "Different groups have different opinions, and if they'd just get on the phone together and discuss issues together they could have dramatic savings in time."
The National Cancer Institute's intramural program has begun to make this change, he notes.
Some studies have to be reviewed by the NCI's Cancer Therapy Evaluation Program (CTEP) and a scientific review board.
So the NCI now holds those meetings simultaneously to speed up the process, Dilts says.
This process change has worked dramatically well for other industries, he adds.
2. Public trust must be built by demonstrating efficiency.
"The public in general, and the cancer patient population in particular have a level of trust in the system that it will produce trials that will advance scientific knowledge," says Joshua S. Crites, PhD, a senior research associate at the Knight Cancer Institute.
"It binds clinical and non-clinical staff to the goal of getting those trials out as quickly as possible while maintaining a constant of patient safety," Crites says.
"No matter how you look at clinical trials, whether it's to advance the state of scientific knowledge or as an alternative therapy option, it remains that there is a moral obligation to current and future cancer patients to reduce the time it takes to produce a clinical trial," Crites says.
The clinical trial industry is well aware that studies are taking too long to develop, but few have thought through this on a deeper level and considered the impact on current and future patients, he notes.
"When people start thinking through the issues they realize it's much more complex and multifaceted," Crites says.
3. Systemize the contracting process.
The CR contracting process takes months, depending on who is on the job, Dilts says.
"One thing that transpires and that is unique in medicine is that it all depends on who the person is who is doing the job," he says.
The contracting process is highly individualized, which is inefficient and unnecessary, he adds.
"Six months ago, the National Cancer Institute announced that when they looked at a dozen or more contracts they found that 80% ended up in the same spot, regardless of where they started," Dilts says.
This suggests that the contracting process could be made systematic and would benefit from such an effort.
Dilts compares the CT contracting inefficiencies to what would happen if manufacturing was individualized and not systematic: "Imagine you're building a car and whether you end up with a Mercedes or a Yugo depends on who showed up for work that day," he says.
"When you talk about the clinical trial process, people immediately talk about the principle investigator — it's much more personalized," Dilts says.
"We're trying to make sure the process works, and once the process works, you can be much more assured of the outcome," he adds.
4. Follow proven best practices.
"There's an incredible amount of knowledge available," says Steven K. Cheng, PhD, a senior research associate at the Knight Cancer Institute.
"Our goal was to document and find the best lessons learned and disseminate the information," Cheng says. "So that's what we've done: we looked at one comprehensive cancer center and the time they took to get through the FDA approval, which was faster than other sites."
After spending days studying the site and how it conducted clinical research, Cheng discovered that one person at the site had learned a shortcut for expediting the protocol to marketing timeline.
It's these sorts of tips and best practices and institutional knowledge that could be written into processes and serve as models for other sites, Cheng suggests.
"Sites can evaluate themselves, comparing themselves to other sites," he says. "Can they do things better than other sites, or can they teach what they've learned?"
Once best practices are established, they should be incorporated into systems that are employed universally, Dilts suggests.
For instance, each study and company has their own case report forms, and these aren't shared. This creates inefficiency.
"If people could just decide on a standard then it would make the process much easier," Dilts says.
This is what happened with the Internet when people finally said it didn't matter which communication system was used, as long as everyone used the same one, Dilts says.
"That's how html was developed," he adds. "No company or patient is going to have a better survival rate because you have a better case report form than someone else."
Several experts on what works and what doesn't in the clinical research (CR) process say there are ways individual research institutions and sites can improve their own site performance and trial speed.Subscribe Now for Access
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