Sean Fenske, Editor06.09.16
Social media is no longer a “shiny, new toy,” but an established communication vehicle that industries can use effectively for a variety of purposes. While we in the publishing industry utilize it to promote articles, breaking news, or an online feature, we sometimes encounter mixed success as not all members of an audience are using the same tools we may use to promote. Or perhaps they just weren’t looking that day. Social media, such as Twitter, moves very quickly and if something is only shared one time, it’s easily missed. In addition, the person needs to be following certain accounts or keywords to see certain information. If someone isn’t following MPO on Twitter, they won’t see what we are promoting unless someone they are following shares it.
The brief lesson aside, social media’s greatest success is most certainly in the consumer/general public space. As a result, industries and businesses are looking at the models there to determine how they might be able to best develop a use case to make it effective for their purposes.
Recently, an interesting opportunity for the manufacturers of healthcare technology has emerged. Specifically, pharmaceutical and medical device companies may have a new purpose for social media that could result in an effective way to resolve a problem that’s been a concern for some time. That is, increasing participation in clinical trials.
One of the concerns among some medical device manufacturers is that they are unable to identify a sufficient number of patients to participate in a clinical trial. If these companies had a way to better communicate directly to the general public to help identify potential candidates rather than going through a physician or hospital, they could significantly increase their potential patient pool for the trial.
As I mentioned earlier, while patients need to actually “see” a tweet or Facebook posting about such a clinical trial, many people follow groups or advocates of a condition they may be living with. As such, they are following those keywords I mentioned or a group they follow may share an announcement from a company about a clinical trial that’s seeking to address a specific medical condition. As such, potential participants don’t need to be following the company directly to get information about the trial.
Now, in such a highly regulated industry as medical device manufacturing, companies may not be so eager to embrace social media as a way to “advertise” a clinical trial. I can understand not wanting to try something new or potentially violating a U.S. Food and Drug Administration (FDA) policy regarding the use of something like social media to attract participants. In looking over the FDA’s guidance on the promotion of clinical trials, however, there doesn’t seem to be any restrictions against its use. At least, nothing in the literature seemed to explicitly forbid the use of social media. And the FDA already permits the use of advertising via other vehicles (television, radio, etc.) for the promotion of a clinical trial. What difference does social media make other than the fact that it’s still new for many and not necessarily viewed in the same light? A person’s perception, however, should not influence the real value the tool potentially holds.
In April, the Association of Clinical Research Organizations (ACRO) released the results of a survey it conducted on “Using Technologies and Innovative Methods to Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs.” While the focus was on pharmaceutical clinical trials, many findings, such as the use of social media, would certainly translate to the medical device industry.
In a letter to the FDA that ACRO sent with its findings, specifically related to the use of social media for the purpose of patient recruitment, it was stated that, “The FDA has been largely absent in addressing issues around industry’s use of social media, especially in the area of patient recruitment. As the agency is well aware, patient recruitment is a major hurdle for clinical trials and social media is proving to be an efficient, effective and direct way to recruit patients outside, or complementary to, the normal channel of investigators. ACRO suggests the FDA convene stakeholders to provide input into a guidance or ‘best practices’ document so this powerful recruitment tactic can be deployed to its maximum potential without fear of regulatory reprisal.”
And therein lies the rub. The use of social media for clinical trials will only see true widespread adoption if the FDA offers its “stamp of approval.” If guidance on its use is provided, if best practices are issued, if the agency acknowledges its usefulness in some way, only then will we see medical device manufacturers utilizing social media as a patient recruitment tool for clinical trials. Without that “approval,” it’s unlikely to ever gain significant traction. Hopefully, the FDA evaluates this opportunity sooner rather than later and recognizes how valuable social media could be for clinical trials.
The brief lesson aside, social media’s greatest success is most certainly in the consumer/general public space. As a result, industries and businesses are looking at the models there to determine how they might be able to best develop a use case to make it effective for their purposes.
Recently, an interesting opportunity for the manufacturers of healthcare technology has emerged. Specifically, pharmaceutical and medical device companies may have a new purpose for social media that could result in an effective way to resolve a problem that’s been a concern for some time. That is, increasing participation in clinical trials.
One of the concerns among some medical device manufacturers is that they are unable to identify a sufficient number of patients to participate in a clinical trial. If these companies had a way to better communicate directly to the general public to help identify potential candidates rather than going through a physician or hospital, they could significantly increase their potential patient pool for the trial.
As I mentioned earlier, while patients need to actually “see” a tweet or Facebook posting about such a clinical trial, many people follow groups or advocates of a condition they may be living with. As such, they are following those keywords I mentioned or a group they follow may share an announcement from a company about a clinical trial that’s seeking to address a specific medical condition. As such, potential participants don’t need to be following the company directly to get information about the trial.
Now, in such a highly regulated industry as medical device manufacturing, companies may not be so eager to embrace social media as a way to “advertise” a clinical trial. I can understand not wanting to try something new or potentially violating a U.S. Food and Drug Administration (FDA) policy regarding the use of something like social media to attract participants. In looking over the FDA’s guidance on the promotion of clinical trials, however, there doesn’t seem to be any restrictions against its use. At least, nothing in the literature seemed to explicitly forbid the use of social media. And the FDA already permits the use of advertising via other vehicles (television, radio, etc.) for the promotion of a clinical trial. What difference does social media make other than the fact that it’s still new for many and not necessarily viewed in the same light? A person’s perception, however, should not influence the real value the tool potentially holds.
In April, the Association of Clinical Research Organizations (ACRO) released the results of a survey it conducted on “Using Technologies and Innovative Methods to Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs.” While the focus was on pharmaceutical clinical trials, many findings, such as the use of social media, would certainly translate to the medical device industry.
In a letter to the FDA that ACRO sent with its findings, specifically related to the use of social media for the purpose of patient recruitment, it was stated that, “The FDA has been largely absent in addressing issues around industry’s use of social media, especially in the area of patient recruitment. As the agency is well aware, patient recruitment is a major hurdle for clinical trials and social media is proving to be an efficient, effective and direct way to recruit patients outside, or complementary to, the normal channel of investigators. ACRO suggests the FDA convene stakeholders to provide input into a guidance or ‘best practices’ document so this powerful recruitment tactic can be deployed to its maximum potential without fear of regulatory reprisal.”
And therein lies the rub. The use of social media for clinical trials will only see true widespread adoption if the FDA offers its “stamp of approval.” If guidance on its use is provided, if best practices are issued, if the agency acknowledges its usefulness in some way, only then will we see medical device manufacturers utilizing social media as a patient recruitment tool for clinical trials. Without that “approval,” it’s unlikely to ever gain significant traction. Hopefully, the FDA evaluates this opportunity sooner rather than later and recognizes how valuable social media could be for clinical trials.
