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.


Pfizer’s “virtual” clinical trial intrigues, but leaves lots of questions

Clinical trials are the backbone of the new drug development process. Without them, you can’t get FDA approval to market your drug. Pharmaceutical companies spend millions, of dollars designing, recruiting for and executing even a single clinical trial, and you need at least three, if not more, to get approval.

Recruiting for clinical trials is challenging. Getting enough patients to completely adhere to the clinical trial’s protocol to have a sufficient data pool may be even more challenging. All of this makes Pfizer’s starting of the first “virtual” clinical trial in the United States an intriguing story, although one that still leaves questions to be answered.

Instead of residing in or regularly visiting a research facility for the entire length of the trial, patients would administer the study drug (Detrol LA, Pfizer’s long-acting formulation of its overactive bladder treatment), as well as monitor and report the necessary vital signs and results, on their own. Pfizer’s project, which goes by the acronym “REMOTE,” is aimed at expanding access to clinical trials, and therefore diversifying the pool of participants, which currently is limited to whoever happens to live near the participating research facilities.

It’s a very interesting idea. And if it works, it could have some very positive results. In addition to improving access to clinical trials, it could save trial sponsors money by not having to compensate participants to repeatedly travel to the research facility.

But there are some very important questions that need to be answered:

  • How many drugs will this type of clinical trial be able to be used for? I imagine that drugs that need to be administered by a medical professional (such as intravenous chemotherapy drugs for cancer) won’t work for virtual clinical trials.
  • How do you go about training participants to correctly monitor and obtain the required data on their own?
  • Do they need to use exactly the same equipment to monitor and obtain vitals?
  • How do you protect the blinding and the confidentiality of the patient data when conducting a trial virtually? Blinding is vital to clinical trials. And patient data must be kept confidential to comply with HIPAA and FDA policy.
  • Would a virtual clinical trial shut out demographic groups that don’t have easy access to the necessary technology? How would this affect the reliability of the data?

I’ll be very interested to see how this project turns out. It could present a major revolution in the pharmaceutical research and development process. Or it could be yet another idea that sounds good in theory but doesn’t work in reality. We’ll see what happens.

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