“Like the “old” Internet, social networking’s value to clinical development will take some time to realize.”

Given the trendy and transient nature of technology fads, I thought I would try and write about social networking’s potential in clinical research before anyone beat me to it. The potential for the technology platform and principles of use which underlie social networking to empower parts of the clinical development process is definitely strong. Unfortunately perhaps, pharma’s track record in adopting new information technology, in the clinical phase at least, is abysmally slow.

Social networking, for those who don’t have teenagers and are over 35, is the most ubiquitous manifestation of “Web 2.0”, where the Internet takes over key elements of our personal and business transactions in elemental fashion, instead of being only a tool in the corner of the room we take out and use like a super-powerful hammer. Social networking is the generic term for sites like Facebook and MySpace, the latter of which in particular is being broadly exploited by those in need of networking (public relations agencies, job-seekers, politicians, real estate agents), for whom it provides literally an exponential benefit. The concern, for clinical research professionals, as it was with the “old” Internet or any other IT innovation, is how is social networking relevant to our work, how do we properly control its use without undermining its benefits, how do we exploit it in unexpected ways that are directly beneficial to the special work we do?

Superficially, the interface and functionality of social networking sites may seem familiar and crude to a corporate user. These tools supply an email analogue, bulletin boards, news feeds, multimedia sharing, document exchange, and other features which corporate users are used to having in a more silo’ed and structured fashion. For the inventors and initial beneficiaries of social networking, those attributes are secondary – they are handy extras to use on a site which is really designed for, well, networking. This is networking in the sense of “old boy networks”; it’s about creating networks gloriously independent of, and unimaginably more specific than, the “old boys” – a truly democratizing (and at the same time, fragmenting) revolution in connecting people, literally worldwide.

Our colleagues in the discovery side of pharma have been exploiting early forms of social networking for some years, such as sharing “wikis” on various specific topics. (A wiki is defined as “a website or similar online resource which allows users to add and edit content collectively”.) Wikis seek to organize information better than the sharing of “blogs” (usually linear writings of a single person on potentially multiple unrelated topics) or discussion forums (originally called “bboards” in the early days and later “threads” – especially if you were/are a Lotus Notes user). None of these Web 1.0 media contain the basis of social networking’s power: the endless linking, de-linking and re-connecting of individuals around the world at digital speeds based on having something in common.

By its nature, social networking is at first glance very problematic for application to clinical research. Clinical research must live in a regulated environment and adhere to the rules of science, not randomness. While serendipity may be at the heart of most of biopharma’s success in the largest sense, we try to avoid serendipity in the details! But what if this essentially new medium can be controlled or steered in a manner which we can benefit from? We need to learn from pharma’s initial rejection of the Internet (a sometimes vociferous rejection whose echoes can still be heard in the corridors of our companies) and suspend our knee-jerk compliance fears until we’ve explored the possibilities fully. Let’s look at two of these possibilities: patient recruitment and trials management.

Discovering Our Subjects

How is social networking different from a Web portal – a “Web 1.0” concept which is still very underutilized in clinical research? Web portals can have all the same functionality accessible to us through a single screen, albeit only with the design and support of lots of IT resources. Social networking’s distinguishing characteristic for us, in this context, is its “discovery” component. Discovery goes beyond the Web 1.0 concepts of “push” (subscribing to news feeds to your desktop) and “pull” (EDC, to use a clinical research example). A recent Wall Street Journal news item about social networking developments gave a great example of discovery: a new Indian restaurant in the suburbs used MySpace and the town’s “network” to discover who had listed Indian food as something they liked. The network was set up in such a way that the restaurant could make itself known to these eager diners, and the result was a level of targeted communication previously impossible to achieve in an open marketplace.

Taking off from this example, an obvious, immediately applicable, use of social networking is for subject recruitment – the most notorious shortfall in clinical research today. Investigative sites, research businesses, academic centers, and CROs can and should all be looking to exploit this new medium to make that essential, informed connection between we researchers and the subjects we require, the patients who can benefit. It is not costly, it is fresh, and the more it is used in daily life, the more likely this can be used in clinical study recruitment. This is much like what happened with the initial objections to Internet-based EDC: the argument that “the study coordinators will never use the Internet” gave way when pharmas realized the coordinators all went home at night to shop on eBay.

But like the “old” Internet, social networking’s value to clinical development will take some time. Fortunately, positive feedback loops in social networking (so-called “viral” networking) operates at Internet speed, so as people tell other people that listing a medical condition or disease interest on Facebook (or wherever) leads to rapid contact with new therapeutic opportunities (in clinical trials), more people will include this information in their profile (certainly the motivated ones, who are those we are looking for in the first place).

Note that all this does is bring a potential subject to the awareness of the site (but of course, that’s all most any patient recruitment scheme does). All of the rigor of informed consent, protocol inclusion/exclusion criteria, and proper site procedures and approvals will still apply. Subject protection and study design rigor are not affected by the magic of MySpace, but making the first step faster and more efficient would be a great boon.

Communicating with Our Faces

Maybe, although not necessarily, social networking will prove to be a more used (usable, accessible, worthwhile) means of communication in clinical trial conduct, at all levels: sponsor to subject, investigator to subject, sponsor to investigator, and more. And perhaps this technology or format will be more useful internally at pharma as well, replacing more static or IT-maintained study portals for the study team. As always, all of these audiences need both general education (on the disease, on the study protocol, on procedures) and news (status updates, alerts to changes, good developments and bad, progress and performance metrics). This is what needs work before social networking makes sense for clinical research: we aren’t dating or job-hunting, we’re trying to learn. Can social networking help us learn? Maybe so.

Is a social networking “wall” better than a dashboard for communicating study metrics? Intrinsically, from a technical standpoint, it is probably worse, but if people use it more – read it sooner, report to it sooner, gain insight from it faster – then it won’t matter. The ultimate value of social networking (in general and in clinical research) will always come to “what’s in it for me”. Since today’s highly complex CTMS’ (clinical trials management systems) are notoriously underutilized at great investment costs, trying something new (and much cheaper) has to be worth the experiment.

The lessons we’ve learned from other clinical IT innovations apply here:

Implementation is more problematic than technology

Getting data out is more valuable than getting data in

Governance and control of how the technology is applied is crucial to success.

I can hear the objections already, so let me list some now. Any tool which adds more email to our day is a disaster. Bulletin boards are filled with recipes and fatuous exchanges about last night’s TV episodes. We’ve already spent years developing “e-Rooms” full of “shared” documents no one is reading. Absolutely true. The only point of social networking is if its unique dimension adds more value than it destroys.

There are subtler implications of social networking that pharma may not enjoy. At present, most sponsors have to help sites find patients for studies, sometimes at considerable expense in advertising and other forms of outreach. If social networking makes it much easier for sites to find patients, is this another way that the power relationship between sponsor and site shifts away from the sponsor and to the site (like EDC shifting data possession to the site)? And there is already tension between patient self-advocacy on the one hand, and the scientific requirements for rigor on the other hand. Will the heightened level of information (and misinformation and disinformation) that social networking generates aggravate these tensions and interfere with successful research?

These are just some of the questions that must be answered before we know if this latest manifestation of technological creativity can be the catalyst for the quantum leap in clinical research performance that the 21st century needs so badly. Our space, our book, is far from full or finished; what is the power of endlessly connected people?