In a hurry to dramatically increase enrollment for a trial? Have traditional methods lost their effectiveness?
Then consider a custom DVD for principal investigators and other research staff. It will get them more invested in what you’re doing and simultaneously provide compelling instruction. Instead of the usual monotonous production featuring talking heads droning on and on for hours, think umbrella lights, actors and camera crews on location in emergency rooms and ambulance bays.
PowerPoint Not Cutting It
That’s what Integrated Clinical Trial Services (ICTS) of Cary, N.C., puts together for sponsors, tailoring the DVDs to the specific needs of the trial. According to Gregg Sweet, VP of training and development at ITCS, your basic interminable PowerPoint training deck just isn’t cutting it these days.
“Those are poorly attended and people sleep through them,” said Sweet, adding that ICTS came up with the DVD concept to make more of an impact on investigators and related staff in less time.
Six Weeks, 100 Percent
Sweet’s shining example, he says, is a recent stroke study. After 18 months, study enrollment was only 10 percent complete. ICTS was called in, the company developed a DVD for the trial, and within six weeks enrollment shot up to 100 percent, said Sweet.
So what enrollment problems existed with that study that lent themselves to this medium? There were many, said Sweet.
Firstly, he explained, the study had a very narrow window for enrollment: patients needed to be signed up and treated within nine hours of their stroke. Therefore emergency medical technicians bringing such patients in to the hospital were key for enrollment, but since EMTs are not typically trained to recruit study subjects, they knew nothing about it.
Secondly, ER personnel needed to know about the study and all its details, but they had little time for lengthy training sessions.
How to Blind?
Third, hospital pharmacy staff required very specific instructions on how to blind the injections for the study. And lastly, hospital neuro-radiologists would have to have training on which very specific MRI and CT scan settings to use.
Clearly, just having one or two investigators or nurses sitting in on a traditional training session at this study’s outset wasn’t working, said Sweet.
Once ICTS signed on, they brought a camera crew of nine to the University of Wisconsin to shoot the head of neuro-radiology explaining the proper imaging settings for the study. Then they traveled to the Cleveland Clinic, where they got shots of leading stroke expert Anthony Furlan. Next, they shot footage inside an ambulance bay, for the benefit of EMTs. And they had an ER physician narrate the 32-minute production.
After a few weeks of editing, each site got the modular DVD—modular in that each involved party (EMTs, ER docs, pharmacists, etc.) needed only to watch the intro, then hit play on the section of the DVD that pertained to them. No sitting around in sessions for hours hearing stuff you may not really need to know, said Sweet.
Something to See
Sweet added that investigators and other medical staff say it helps tremendously to have step-by-step visuals of exactly what needs to be done for a study, instead of just a written document filled with instructions.
Cost to this particular sponsor? $395,000, far cheaper than the cost of a trial failing due to inadequate enrollment, said Sweet.
Law and GCP
Other ICTS DVD projects have run as high as $500,000, and as low as $75,000. “It depends on how compelling the client wants to be,” said Sweet.
The company has also done parodies of TV shows (CSI, Law and Order) to outline Good Clinical Practice principals. Unfortunately, says Sweet, many sponsors don’t think to contact ICTS until recruitment for a trial has already gone badly awry.
“They would be much better off if they thought of us at the start,” he said.
—by Suz Redfearnd9A2t49mkex