Two myths of patient recruitment

An invitation recently arrived by email to attend a podcast purporting to show how promoting clinical studies in social media can seriously boost patient recruitment. The podcasts's underlying premise constitutes yet another contribution to the radically exaggerated, even misleading notion that IT now makes health care hugely better, cheaper and more easily available.

At some point electronic media will boost efficiency in health care, but it will be several more years before that desirable situation becomes reality.

In the particular area of patient recruitment for clinical trials, two myths persist among pharma's wishful thinkers. The first concerns the aforementioned notion that a sponsor can get patients clamoring to enroll in his trial by building a following on Twitter or Facebook or some other facility devoted to minor chatter and selfies.

Some proponents claim that the royal road to recruitment goes through message boards devoted to a particular disease.

The idea is not totally preposterous because people can find suggestions related to health care anywhere. If they are wise and they find such suggestions interesting, they can then explore them seriously, first online and after that, with health care professionals. In some situations such as those involving patients with either allergies, obesity or pre-diabetes, recruitment may get boosted by going directly to patients and informing them of trials to test new a medication. In most cases, however, especially those involving relatively more serious conditions, the notion that internet chatter can produce substantial enrollment is either foolish or cynical.

At some point either a person's family physician, her specialist, an investigator for the trial in question or someone else will tell a patient who does not already know it that entering a clinical trial should not be based on impulse, the basis of most consumer purchases online. A first point to keep in mind is that trial subjects maintain a good chance of receiving a test drug whose effects are not fully understood. Then there is the fact that someone who is presently well maintained on a treatment regimen should not expose herself to the risk of a trial for matters of minor convenience or other superficialities. Only if currently approved medications cannot provide adequate benefit, does it makes sense to seriously review the prospect of enrolling in a trial with one's physicians and other well-informed sources.

In addition to the cautions noted above, the "buying" impulse that social media may prompt can also be impeded by study coordinators and investigators at trial sites. Even though study site personnel stand to profit when they enroll patients in one of their studies, they must carefully explain to each candidate the test drug's presumed benefit, its safety/tolerability hazards, the number of required clinic visits, the intrusiveness of each visit, and how participation may affect work and home life.

A prudent candidate will then take that information from someone at a trial site and review it with her physicians, family and others. The extent to which a dozen Tweets and the comments of unknown scribblers on a message board prevail over this careful scrutiny appears open to question.

Then there's the fact that the process of boosting patient recruitment through social media represents an unstable combination of marketing and medical advice. In most such cases, the marketing objectives tend to overwhelm the medical advice. Much to their credit, most pharma executives know that social media represent a legal minefield of tort liability for them, so their use of it remains limited. The industry's major promotional media -- reps, medical meetings, journal articles and television -- already pose legal and ethical issues. One has to question the value of opening yet another can of media worms.

So the use of social media to enhance patient recruitment seems both dubiously productive and fraught with legal/regulatory issues.

The other IT fantasy related to patient recruitment emerges from the near universality of electronic medical records (EMRs). Somehow the notion got around that because physicians and hospitals have adopted EMRs, patients can be efficiently located for trials by entering some key terms into the database, whereupon it will produce the names and pertinent data of all likely candidates within each queried practice.

If wishes were fishes, we'd all swim in riches.

Within the next decade, IT may enormously facilitate the patient recruitment process. Current tech capabilities, however, put this prospect at some distance on the horizon.

For starters, there is the fact that several EMRs are currently in use by providers and the ability of any of them to communicate with the others remains limited. Even taking all of them as a group, they are not sufficiently articulated for entering a trial's particular inclusion/exclusion criteria and emerging with auspicious candidates.

A day will surely come when an ambitious, resourceful IT entrepreneur solves these difficulties, thereby moving patient recruitment into the realm of efficient, industrial project management. Right now the capability does not exist. One reason for that is a socio-economic barrier. American medicine still maintains its legacy as a 19th-century cottage industry that resists the rationalization required by large provider networks and major payers. It would be as if Henry Ford tried to introduce his assembly line system into an environment where automobile assembly was dispersed among a thousand garages around the state of Michigan.

The changes in pre-existing factors needed to make EMR-enhanced recruitment a reality are underway. Right now, however, any sponsor hoping to accelerate a clinical trial by relying heavily on electronic media is likely to first see his compound's patent life expire.

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