ACRO, symptoms, and health outcomes and can learn from

ACRO, the Association of Clinical Research Organizations, recently
announced the launch of its YouTube channel to educate the public, media and
policymakers about clinical trials and the growing role of clinical research in
drug development. The power of social media, while undeniable, requires a
judicious sharing of best practices.

Some other note-worthy websites include The Center for Information and Study on Clinical Research Participation (CISCRP), a non-profit organization dedicated to educating and
informing the public about clinical research; and clinical trial recruitment
sites, such as ClinicalConnection, TrialReach, EmergingMed and CureLauncher which exist to match eligible patients to appropriate trials. The TrialX site encourages patients to send a tweet to @trialX, preceeded by
“CT” describing the type of clinical trials they are seeking.

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Social media’s reach and on-the-go portability via smartphones make it
very attractive to both researchers and drug companies. The advent of iPads and
iPhones makes mass communication much easier for everyone. Some cancer-based
LinkedIn groups bring together patients and their doctors and have even been
utilized to find surgeons who will remove inoperable cancers.

 

Peer influence to generate interest in participating in a trial is
another method to generate social media clinical trial recruitment. PatientsLikeMe which now claims more than 250,000 members worldwide, hosts all
kinds of disease communities where patients can track their medications,
symptoms, and health outcomes and can learn from other patients whose profiles
resemble their own. It allows the industry to look at aggregated data from its
communities. And now it allows them to partner with pharma companies to
announce clinical recruitment trials through its online communities. These
communities allow potential patients and their loved ones to access information
and connect with others in similar situations. It also keeps the conversation
going with potential patients by creating a place where people who applied but
didn’t qualify for a trial aren’t left feeling abandoned and may

 

 

remain open for a different trial. In turn, this continues to build upon
a targeted pool of potential participants that may be needed in the future.

 

 Other patient sites like MyHealthTeams, Inspire (utilized
by the Mayo Clinic pilot study) and armyofwomen.org do the same. Another benefit to online forums is that study
sponsors streamline the often costly and time-consuming process of finding and
screening potential trial participants. These forums can contain a series of
prescreening questionnaires and informational videos, and also offers multiple
methods for prospective study participants to interact with study coordinators.

                                                                 
                     

Pfizer, which calls itself the world’s largest research-based
pharmaceutical company, launched a new program in 2011 called
“clinical-trial-in-a-box”. The project was said to be the first randomized
trial of its kind allowing patients to participate completely from home.
Regardless of geography or proximity to the researchers, patients are able to
participate in a virtual trial through the use of a mobile phone. Stating
publicly on its blog, ThinkScienceNow, Pfizer said it wants to reinvent the
clinical trial, and is committed to improving the experience for patients. As
reported on the blogosphere, Pfizer hopes its approach to research will
ultimately save patients’ lives and the industry time and money.

However, in early 2012, Pfizer discontinued its project. Craig Lipset,
Head of Clinical

Innovation at Pfizer, said in a June 2012 blogpost: “I want to clarify
that our withdrawal of the virtual trial does not represent a failure of the
Internet or social media for patient recruitment.

 

FDA Regulation of Social Media Content

It is
also important to note that the U.S. Food and Drug Administration has developed
guidance for the proper use of “interactive promotional media” (e.g. blogs,
microblogs, social networking sites, online communities, and live podcasts) by
pharma companies. In summary, the FDA says a company is responsible for product
promotional communications on sites that are owned, controlled, influenced or
operated by, or on behalf of the company. (To meet postmarketing submission
requirements, the company must submit to the FDA the promotional content it
generates.) Furthermore, the company is responsible for promotion on
third-party sites, even if that influence is limited in scope. In addition, the
company is responsible for the content generated by any employee or agent (e.g.
a blogger) who is acting on behalf of the company to promote its product.
Having an understanding of FDA rules, as well as FTC and SEC regulations, for
public companies, is advisable.

Separately,
the FDA has also developed guidance for the use of social media platforms (e.g.
Twitter) that only allow a limited number of characters per message. Within the
available space constraints, pharma companies are advised to balance accurate
information on benefits and risks of their products as well as a link to more
detailed information. If the company concludes that these features cannot be
communicated in a character-space-limited communication, the FDA suggests the
company should reconsider using that platform.

To make expectations even more clear, FDA.gov now lists requirements for medical researchers recruiting
volunteers via social channels. Included on the list are the following: 

·        
Social
advertisements should not suggest “free medical treatments,” when, in
fact, participants, are simply not being charged to take participate
in a subject recruitment.

·        
Advertisements
can tell participants they will be paid, but posts should not emphasize
payments using larger or bolder fonts than what is used throughout the rest of
the post.

 

·        
Recruitment
ads should primarily focus on only what is needed to determine “eligibility and
interest” of potential participants.

 

Additionally, although not required, the FDA asks those recruiting for
clinical trials to include some of the following information in their
social posts:

·        
The name
and address of the clinical investigator and/or research facility

·        
The
purpose of the research

·        
A
summary of the criteria used to determine who can participate

·        
An
overview of potential benefits, if any (for instance, a “health examination at
no cost”)

·        
The
expected time commitment

·        
Link for
consumers to follow to learn more information

 

In
a well-known example, Kim Kardashian promoted a brand of morning sickness
tablets on Instagram that forced the FDA into action to bring the advert down
for not including safety information. The company in question managed to raise
millions of views for their product but got away with only a warning. It’s a
regulatory minefield, both for companies and for the regulatory agencies.

 

According to at least one institutional review board (IRB) survey, the
number of “don’ts” on social media is growing and so it’s important to remember
the following:

• Don’t promise positive outcomes for any drug or trial

• Don’t communicate that any product is safe, or provides superior
results

• Don’t say a product is approved by any regulatory body

• Never promise free treatment, or emphasize any incentive payments

 

The tendency has always existed for patients to attempt to gain insight
into their treatment particularly in placebo-controlled or blinded comparator
trials. The drive for self-preservation is a powerful force that must be recognized
but cannot be controlled when conducting clinical research. Even prior to the
rise of social media when patient inquiries were limited to patient
interactions in the investigator’s waiting room or outside the clinic, this
potential to compromise data integrity did exist. But the potential is much
stronger now.

As much as possible, information to patients must be provided that would
help them to determine their own eligibility and interest in clinical trials.
Many IRBs in the US do not have policies or guidance in place to resolve
conflicts, so it might be prudent to consider hiring a social media expert to help in planning.

Despite any limitations these regulatory requirements may present, it
appears that the use of social media in clinical trials is here to stay.