How the FDA Can Harness Social Media for Improved Patient Access to Treatments & Clinical Trials
Below is a letter several of us wrote and submitted to the U.S. Food and Drug Administration around the U.S. Food and Drug Administration’s November 12 & 13, 2009, Advisory Committee Meeting hearing around the use of social media.
Dear U.S. Food and Drug Administration:
There are many required activities to bring a new drug into the hands of the people who need it most. We believe the most important role is played by the drug development, clinical research, and patient recruitment process. To assist your agency’s Advisory Committee on crafting guidelines regarding Internet and social media tool usage to promote medical products, we write to you to offer our recommendations. We also provide our thoughts concerning relevant topics that we feel are crucial in determining your policy decisions.
- 70 thousand clinical research studies are conducted at any given time.
- An estimated 2% of the U.S. population participates in clinical research studies with more than 70% of those participating likely to do so again (CISCRP).
- 94% of the public recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state they have little to no knowledge about the clinical research enterprise and the participation process (CenterWatch).
- 57% of Americans say they would be likely to participate in clinical research (CICSCRP).
- Less than 5% of Americans know where to find information about relevant clinical trials (Getz, Tufts University)
Thus, the need to raise awareness of clinical trials among the public has never been more crucial. This demands that all media channels be harnessed, including traditional and digital means.
When drugs obtain FDA approval, marketing, advertising and communications initiatives are used to raise awareness of these new products. Likewise, at the beginning of the clinical research process, those same media initiatives are used by drug sponsors to help patients find treatment alternatives available in clinical studies. Every patient enrolled into a clinical study accelerates the advance of science and brings new viable treatments closer to reality.
We believe that raising the awareness of clinical research is an essential part of the drug marketing equation and is one that you must consider seriously. Why? Because more Americans are turning to the Internet to find medical information, so we need to help them find credible sources to make informed choices. Moreover, use of media, including social media, can serve as powerful agents to assist with patient enrollment, and ultimately in helping to bring new treatments to patients in need.
For more than 20 years, patient recruitment has been focused solely on attracting patients into clinical research studies by traditional marketing, advertising, and community outreach efforts. Our belief is that patients are best served by maximizing all communications channels, from traditional advertising to public relations to social media.
Historically, broadcast and print media have been used to great effect to enroll patients into clinical studies. With the advent of social media communication, we have witnessed an increasing use of this medium for patient recruitment purposes. Patients are finding it easier to search for alternative therapies online and gain access to treatments that they may not have been able to get or afford elsewhere. With 61% of American adults seeking medical help online, this trend will likely increase.
Since the FDA currently allows for live television and radio interviews on scientific studies, clinical research, and FDA-approved drugs to be conducted with thought-leaders, we believe that a working model for communication in “real time” already exists. It is our recommendation that this model be adapted for crafting social media communications guidelines.
The rules governing Satellite Media Tours (SMTs) and Radio Media Tours (RMTs) provide a perfect example of the flexibility required for social media communications messaging while also adhering to FDA and HIPAA requirements. During TV or radio media interviews, the clinical study spokesperson must faithfully respect the core content requirements approved by the IRB, yet is given latitude to address the questioner appropriately. That is, the response of the study spokesperson is not pre-scripted because the question is unpredictable. However, the foundational content from which the spokesperson may cultivate his answer must align as closely as possible. This allowance for adaptive response provides a perfect balance between the need to honestly inform the public and still conform to the nuance of live conversation.
It is this same balance that we as practitioners within the social media realm seek from the FDA as it develops its guidelines regarding social media for patient recruitment. Sites such as Twitter, MySpace, Facebook, and others have instant messaging functionality, rendering their format akin to live Q&A sessions on radio or TV. The spontaneity of conversations, particularly on Twitter, requires an adaptive framework to achieve transparency and trust within these mediums from ordinary users. Simply sending IRB-approved promotional messages about a clinical trial without using the medium in ways typical of a common user raises suspicions of spamming. We ideally envision using this medium through messages that are faithful to IRB-approved core clinical study content, without the rigidity of a pre-fabricated response. That is, allowing adaptive messaging that conforms to IRB-approved content is crucial to communicating effectively and establishing transparency and authenticity. This approach means viewers won’t have to be subjected to canned messages and awkward responses, but can rely on a fluid conversation that honors social practice. Given the character limitations of certain mediums (e.g. Twitter’s 140-character text limit), we also see a need for flexibility in messaging through acronyms and abbreviated responses.
Using Twitter as an example, a typical user will “re-tweet” (or re-send) messages of others deemed newsworthy or interesting. Likewise, Twitter users “follow” other users online to stay attuned to their messages, just as Facebook and MySpace users adopt “friends” to become a part of their social network. These typical uses form the etiquette of participation. This behavior helps viewers on social media sites to intuitively determine that the message sender is a bona fide human and not an automated spammer. Hence, we think that alongside IRB-approved clinical study awareness messages, there should be an allowance for non-study related messaging that includes news clips, resource links, re-tweets, and allows for the free exchange of conversation in much the same way that live radio and television Q&As are now managed by the FDA.
Accordingly, we encourage the FDA to expand its rules in the public relations area, specifically its SMT and RMT rules, to embrace the social media tent. We believe that the familiarity with these current rules among all stakeholders provides the necessary predictability and assurance that the public and communicators expect, while streamlining the FDA’s administrative responsibilities. All learning curves are avoided by applying tried-and-true rules already in place. We add that the success of the current regulatory framework for live television and radio is predominately because it is geared to their mediums. By expanding this long-standing rubric to social media, which shares its characteristics, the FDA can confidently predict a good fit. Protecting the safety and welfare of the public depends on rules that have proven their muster. We sincerely believe that the body of rules governing television and radio messaging for patient recruitment in a live forum meets this benchmark and should be adopted for social media.
As you consider the commercial market in developing your policies on social media usage, we encourage you to consider what is taking place on the clinical side. 87% of clinical trials should not be failing due to lack of patient recruitment. This number is too high and the toll on waiting patients seeking new treatments is unconscionable. Social media communications can help us close the gap between patients and the trials available for their participation. By developing concrete social media guidelines in the clinical research arena, your agency will bring expanded access of alternative treatments to patients across this country.
We are eager to make further recommendations to assist your mission and welcome your feedback. Thank you for your consideration.
- Leigh Fazzina, Sr. Healthcare Communications|PR|Social Media Consultant
- Carmen R. Gonzalez, Patient Clinical Trial Recruitment Strategist
- William Stone, Sr. Healthcare Marketing Consultant
- John Benbrook, CEO, MMG
- Christine Pierre, CEO, RxTrials Inc.
- Deborah R. Tunick, RN, Director of Clinical Operations, Chesapeake Research Group, LLC
- Ira J. Gottlieb, DPM, Medical Director, Chesapeake Research Group, LLC
 Pew Internet & American Life Project, June 11, 2009; http://pewresearch.org/pubs/1248/americans-look-online-for-health-information