Thursday, January 20, 2011

The FDA and Social Media: The Industry Needs Guidelines

If you love irony, you’ll love the following.

Respondents to a Deloitte study said social media likely could improve clinical trial efficacy in two ways: one, by supplying data to quicken reporting results, and two, to determine the correct patient reported outcomes.

But of course, these respondents aren’t likely to investigate whether these presumed efficiencies would actually work, because the FDA has put off, yet again, its guidelines on how industry can use social media.

Social media is already proving some success, says FierceBiotech, in recruiting and retaining clinical trial subjects.

It’s a head-scratcher. Facebook has more than 500 million users; half of them log on every day. The average user has 130 friends. As for Twitter – and these are older stats – it has more than 105 million Tweeters, yours truly included.

Do we need to list the problems that clinical trial researchers have had over the years in conducting quality trials, in trying to meet all the rigorous criteria? Remember the media attention the FDA’s report received last year regarding the lack of monitoring of overseas trial sites? That report showed that “between 40 percent and 65 percent of clinical trials investigating FDA-regulated products are conducted outside the United States.”

We can take an educated guess as to why the agency is putting off publishing its guidelines – the unknowns are enormous. More than half of the 208 Deloitte study respondents say there will be confusion – in interpreting the guidelines, in administering the guidelines -- after the FDA publishes them.

We say, that’s okay. At least we’ll have something on paper and a place to start. The agency can redact as we move forward or modify moving forward. But just like the internet in general, the world is moving to more adaptable, amorphous content built by communities.  The FDA and other regulators around the world need to appreciate that fact.

As things are now, many industry members are willing to take risks, and spend money on social media innovations, but, as Deloitte points out, innovation is developing slowly, as members wait for the agency’s lead. We think there needs to be another approach. Again: The agency should develop regulations that are progressive, adaptable, and modifiable.
But industry members could get restless, and venture into unchartered areas, as Novartis did last year – and got its wrist slapped for it. Is that fair? No, it isn’t. The technology is here, possible solutions to major problems are here, and the agency, in our opinion, should pick up the pace.

No comments:

Post a Comment