The U.S. Food and Drug Administration (FDA) understands you can’t control absolutely everything posted about your drug or device as part of your effort to solicit new clinical trial subjects, but you’d better keep an eye on promises made regarding how much your product can benefit people. That’s the warning from Mitchell Parish, JD, RAC, CIP, a senior regulatory attorney with Quorum IRB.
FDA also wants you to be proactive when it comes to informed consent and recruitment of potential trial subject, Parish adds. That’s tricky when you go online to find new folks via Facebook and the like. It gets even more troublesome when promises are made or implied that your drug and device can do all sorts of things that don’t strictly adhere to the trial protocol.
It’s critical to have in place a plan to monitor and control, to a realistic extent possible, online chatter about your drug or device, Parish says. For example, FDA will examine whether you encouraged, directly or inadvertently, a comment from someone extolling off-label virtues of the product. It’s also important to remember that product claims require institutional review board review and approval, yet objective information isn’t under the same scrutiny. It’s important to know the difference and have a plan in place with defensible definitions of each, says Parish.
Ironically, one of online recruitment’s biggest strengths is also one of its most glaring weaknesses, says Owen Garrick, president and chief operating officer with Bridge Clinical Research. “You see patients and caregivers flocking to social media sites” and willingly sharing information and health tips, he notes. That’s great, but according to Garrick, it also raises thorny questions over how to effectively track promises of efficacy and impact for a drug and device.
“People have become so comfortable sharing that kind of information,” Garrick says. The trouble often begins when patients praise what the drug has done for them personally.