In an era where there is a new app released every five seconds or so, that allows people to converse with each other and share intimate details about their lives, what exactly is privacy? Some of the apps, such as Whisper and Secret, offer an anonymous way to share just about anything. Others like Snapchat, Frankly, and Telegram, house personal messages and photos which self-destruct after they are read. In the app Secret’s latest version, confidential facts are shared among friends and these posts can spread to more extended circles, based on the number of “likes.”
I have one comment for all this sharing, “Who cares.” Okay, that’s a bit harsh but what I mean to convey is not every move someone makes is worthy of sharing and in fact, there are risks associated in “over communicating” and the inherent lack of privacy that surrounds sharing is primary among them.
Patient privacy is an issue that touches every stitch in the patient-care tapestry. Think of the reception area at a busy doctor’s office with three administrative assistants sitting in a tiny pod surrounded by a sea of medical record folders. As we dutifully sign our HIPAA forms, we are bombarded with the reception staff’s phone and in-person conversations, which are most assuredly disconcerting to all of us in the waiting room. Thank you, Mr. Smith. We will make sure to order the Zoloft for you today. That’s 200 mg daily and your address is 165 Whose-Business-Is-This-Anyway Road…
In the clinical research and development community there is much debate, concern, and confusion regarding protecting patient privacy. As the process of direct-to-consumer outreach to convey clinical trial participation opportunities sophisticates, there needs to be more widespread understanding of the evolving threats to revealing patient identifiable information. Here’s one that BBK Worldwide (BBK) struggles with as we work to explain to sponsors the efficacy of their advertising dollars vis-a-vis enrollment success.
When a consumer completes an online screener and provides his / her name and email address, it seems logical to assume that BBK’s Patient Recruitment Management System (PRMS) TrialCentralNet (TCN®) should provide a tracking route for this patient from inquiry through consent, through enrollment, and retention study participation. A system renowned for its ability to provide detailed analyses by site, by country, by region on the impact of any recruitment activity from a support call to a site; to a reinvigoration meeting; to the receipt of study materials, should be able to connect the dots between an advertising respondent and an enrolled patient.
But, here’s the rub. When consumers interested in learning more about a clinical trial provide their contact information via an online screener or through a call center, they are agreeing to be contacted to pursue a conversation with a health professional about this potential treatment option for them. A signed consent makes this same consumer a patient of the site and a participant in a clinical trial. These two actions are independent approvals and have no legal or moral connection to one another. BBK takes the stance that best patient recruitment practice and Good Clinical Practice (GCP) dictate that this consumer’s email and this patient’s enrollment code, albeit the same person, should not be connected in order to best protect individual freedom and privacy.
Now a forward thinking recruitment consultant could include stipulations in the terms and conditions of the website and online screener, explaining the connection between consumer and enrolled patient as it relates to confidential information. However, BBK takes the approach that legal wording is rarely carefully perused by the consumer and if this consideration concerning personally identifiable information were included in a more prominent position on a website, there is a good chance that this wording would set off a red flag for Ethics Committees, and justifiably so.
Are there any more considerations we can pile on this scenario? Yes, there are. In fact, there is absolutely no need to even consider the scenario of connecting an advertising inquiry to a consent and then to a retained patient. This information falls into the category of “Who cares.” I can hear the outcry now: “Why?” “How can you say that?” I can say it because with the robust reporting available through TCN, we simply don’t need to infringe on privacy in order to understand advertising efficacy. Consider the following data BBK has analyzed from the aggregation of data from hundreds of studies in which the protocol and therapeutic patient condition necessitated advertising enrollment support:
- Sites receiving referrals generated by BBK advertising efforts always have higher enrollment rates than sites that are not supported by advertising.
- In the two weeks post a run of well-planned advertising, those sites that viewed referrals have higher enrollment rates than sites that did not view the referrals received.
- Advertising supported by an online prescreener and a call center result in greater conversion rates as seen by enrollment numbers four weeks post advertising than advertising efforts where the sites’ phone numbers are promoted. Even research sites perform better through a centralized referral system, even though they manage direct receipt of inquiries, better than “care” sites.
- Site enrollment rates increase in the four weeks post advertising and then decline to a base level until the next flight of advertising is initiated. Often, the base level maintains at a higher rate than the base seen prior to advertising.
- There is a direct correlation between data compliance on the site’s part regarding the management of referrals and the efficacy of the advertising with regard to ensuing enrollment rates.
- The performance cascade tracks clearly: advertising; call center; online prescreener; site referral views; site data management; in a cumulative fashion positively impact enrollment rates.
Let’s apply the constructs above to a recent CNS study metric presentation.
We can see that a study gained 2,500+ referrals from healthcare consumers through a website and call center data. We know that 93 percent of these referrals’ contact details were viewed by an individual at the sites that had access to TCN. We see that sites that viewed these details performed better than sites that did not receive, or did not view their referrals. We see that in every single case where media outreach was applied, a corresponding, trackable bump in the screening rate occurred at sites that received that support. Conversely, no bump was recorded at any sites that did not receive support. We conclude that the accumulation of BBK-related support caused the increased screening activity at the supported sites. By discounting the trackable bump in screening rates we can determine that BBK saves several months in the recruitment timeline.
It’s like a crazy Pavlovian conditioning to want a metric that’s not valuable or necessary – and that may indeed threaten patient confidentiality – when better information is there to assist the strategic decision-making process. If the protocol, condition, and competitive circumstances dictate the need for advertising, this critical, tactical maneuver must guide everything from the selection of countries and sites; to the training and support of sites; to the analysis and reporting of performance metrics.
As sponsors and CROs evaluate clinical study needs behind closed doors, it is clear that the dialogue regarding advertising and efficacy has to change.
Stay tuned for part two of this two-part series by Matt Kibby: Inside Baseball: A Conversation About Meaningful Data and Analysis, and Patient Recruitment Tactical Efficacy.