Clinical trial sponsors, investigators must now account for social media in study designs

The Pink Sheet is a newsletter on the pharmaceutical industry read by many drug manufacturers. One recent issue had a report discussing the impact of Social Media, such as Facebook, on the design and execution of clinical trials.

You can read the whole story here: Social Networks in Clinical Trial Design

Clinical trials, in particular the all-important Phase 3 Pivotal trials, cost many millions of dollars to execute. They are designed meticulously, especially when it comes to blinding and randomization controls. Study subjects can’t know whether they took the study drug, the placebo (or, if applicable, the comparative drug) until after the trial is completed. If they did, they might not react naturally or adhere to the study protocol, and the trial results could be compromised.

Derrick Gingery reports:

Craig Lipset, Pfizer senior director in clinical research, said patients are using chat rooms and forums directed at specific diseases, in some cases talking about the clinical trials in which they are participating and their experiences with the study drugs. The online talk could threaten a trial’s blinding and randomization, especially as patients are more able to interact with other trial participants, he noted.

At the same time, as Lipset says later in the story, asking clinical trial subjects to refrain from using Social Media is not realistic. Recruiting subjects for clinical trials and getting them to follow existing protocols is hard enough as it is. So trial sponsors and investigators need to account for these tools in designing clinical trials.

Lipset’s employer, Pfizer, took a step in this direction this past June by conducting a virtual clinical trial for the long-acting formulation of Detrol LA. Other drug sponsors, investigators and CROs (contract research organizations) will likewise need to design clinical trials with Social Media in mind.

At the same time, researchers and pharmaceutical companies can also use Social Media to their advantage. While comments on a Facebook page or an internet message board are not statistically reliable or a substitute for the FDA’s adverse events reporting guidelines, they can provide hints of problems  before they become catastrophic public relations disasters. On a more positive note, sponsors can, as Gingery reports, tap into social media to recruit subjects for clinical trials.

 

FDA social media guidance delayed again….until 2013!

I’m never surprised when government acts very slowly. But it has gotten beyond that now with the FDA’s pharmaceutical social media guidance. As Ogilvy’s Rohit Bhargava appropriately notes in the headline for this piece, the FDA just doesn’t appear to be that into providing guidance on social media.

Bhargava, citing an FDA document that outlines the agency’s priorities for 2011-2015, reports that a social media guidance, originally expected to be released by the end of last year, now likely won’t be released until at least 2013. Not for another two years. Even if the FDA actually releases a guidance that year (yeah, right), it will be almost four years after it held its public hearing on social media. It will also be almost 10 years after the debut of Facebook, seven years after the debut of Twitter, and even longer after message boards, blogs and ratings sites became available to the masses.

By then, the FDA will be way behind the times on this technology.

Pharmaceutical companies should probably give up waiting for FDA guidance at this point, if they haven’t already. It’s clear that they need to participate in social media. So they should just develop their social media plan and policies as best as they can using existing DDMAC guidelines. Use common sense and pay attention to when the FDA flags other pharmaceutical companies for violating DDMAC guidelines with social media, so you can learn from others’ mistakes.

It’s by no means an ideal way to go into social media. But the FDA clearly doesn’t care enough about this to publish a guidance anytime soon. Pharmaceutical companies still waiting can’t wait any longer. Just do the best you can with what you have.

 

 

E-patients: The changing face of healthcare

In honor of its 100th Anniversary, Swedish Medical Center of Seattle ran a two-day symposium on health care in the age of reform. I really wish I had been able to attend this in person (if only it didn’t take 6 hours and more than $500 to get from Philadelphia to Seattle, not even including hotel), but technology and my work schedule fortunately allowed me to watch parts of it online. I especially enjoyed one of the preliminary events covered health care in the age of social media – a topic very dear to my heart (as you can probably tell from this blog!).

There were two featured speakers at this preliminary event – Seattle Pediatrician Wendy Sue Swanson (author of the Seattle Mama Doc blog) and Dave deBronkart (better known in the twitter-verse as “epatientdave“). Dr. Swanson’s keynote speech was certainly outstanding in its own right. But deBronkart’s speech was particularly noteworthy because he discussed a concept for which he is one of the leading champions – the “e-patient.” And that concept is becoming an increasing factor in healthcare, one which patients, providers, pharmaceutical companies and insurers alike would be well-advised to heed.

In January 2007, deBronkart was faced with Stage IV cancer. He was given about 24 weeks to live. But he beat the odds, and defeated the disease by that September. Since then, he has advocated for patients to have more access to health information, and for patients to use this information.

The graphic in this post (credit Kru Research) gives a very specific definition of an e-patient, but the bottom line is that e-patients are smarter health care consumers who are able and willing to participate more in their health care. Both through reading on their own and conversing with others through social media tools, patients are entering the doctor’s office armed with more knowledge about their condition(s) than ever before.

The resulting practice, commonly called “participatory medicine,” is having a major impact on health care. Patients who know more about health issues and treatment options are able to ask better questions in the doctor’s office. Rather than blindly follow “doctor’s orders,” patients are increasingly managing their health in partnership with their doctors. This trend is also apparent with pharmaceutical manufacturers and even with insurers.

deBronkart’s story is a very moving and inspirational one, and can be read in more detail in his book Laugh, Sing and Eat Like a Pig – How an Empowered Patient Beat Stage IV Cancer (and what healthcare can learn from it).  Click here to order it through Amazon.com.

Pharma can learn lesson from GSK re: Avandia, social media

Pharmaceutical companies, and any business for that matter, can use social media to communicate directly with customers. They can also use it to monitor their publics’ reaction and get feedback – both directly and indirectly.

According to one report that crossed my Twitter feed this week, pharmaceutical giant GlaxoSmithKline could have found out about adverse events with its diabetes drug Avandia if it had been monitoring social media in 2004 – two years before meta analysis officially linked the product to a higher risk of heart attack.

Obviously, few, if any, businesses monitored social media in 2004. But message boards and blogs (albeit more rudimentary ones than found today) did exist then. And according to Marc Iskowitz of Medical Marketing and Media, even then, consumers were raising questions about Avandia’s safety on blogs and message boards.

There is a lesson here for GSK and other pharmaceutical manufacturers reluctant to embrace social media: use those tools to hear what your customers are saying. You may be able to nip a problem in the bud before it becomes an all-out catastrophe for your business.

Since GSK didn’t actively monitor social media back in 2004, Avandia’s potential safety issues didn’t come to light until 2006. Now the product has become the subject of more than 13,000 lawsuits (of which GSK has settled approximately 11,500). Late last month, the European Medicines Agency recommended that Avandia be removed from the European Market. The drug is also under investigation by the FDA in the United States. And Avandia sales dropped by almost 50% from 2006 to 2009.

Had GSK seen that patients were complaining sooner, it might have been able to identify the problems, or potential problems, on its own, before someone else did. It still may have lost some sales, but it would have avoided the PR damage. It could have demonstrated transparency in an industry that has very little of it and quickly worked to rebuild trust with its customers and the general public.

Hopefully, now that even pharmaceutical companies are increasingly using social media, they will learn their lesson.

 

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