Craig Lipset, who heads clinical innovation at Pfizer, is conducting an innovative post approval clinical trial. His idea is to see how cost and process are impacted by recruiting and monitoring patients only via personal technology, social media, and the internet. In an interview posted 3/12/2012 with Ed Silverman, on Pharmalot blog, Craig gave an update on the trial’s progress.
Pfizer has noticed that while the trial has gotten lots of attention, it has not translated into high recruitment yield. There is plenty of interest and traffic on the trial websites, however patients are hesitant to actually take the next step and enroll. Lipset had several theory’s for this hesitancy including, a lack of overall education about clinical trials, the general population’s wariness of the internet security and of sharing PHI online, and most importantly, lack of human interaction pre-enrollment.
Sometimes we in the industry get so caught up with process, we forget that to outsiders, clinical trials can be very intimidating. Having been involved with subject recruitment for 20+ years, and participated in CISCIP clinical trial awareness events, I have experienced this fear firsthand. While clinical trial professionals know (and often curse) all the regulations the FDA, IRB’s and others have put in place to protect patients, most lay people are not aware of them. By not having a human touch to explain the process, or answer questions (even with specific scripted answers), patients will be very reluctant to share any health information. Lipset himself acknowledges this by saying “A very important takeaway is that online is great, but make sure these folks know they’re not alone and have a sense of contact that they need… The twist here was to go from awareness to randomized participant entirely online, and this is where ensuring some human contact as well as an optimized online process have proven extremely important.”
The traditional programs for recruitment, especially those with big media buys and call center screening, can be expensive, and if not designed correctly often play out with low ROI. That is why many organizations look to other options to reduce recruitment costs. Many potential volunteers are comfortable with technologies like IVRS (especially the new AI IVRS systems), and online screeners as a first step for pre-screening. And once enrolled, many subjects are comfortable with automated data collection for diaries. But in the 250+ trials we were involved in, every respondent knew that there would be someone to answer their questions somewhere along the line, either via a call center, or at a study site. And that reassurance was very important in their decision to participate.
We need pioneers like Pfizer to try different approaches. Any technology that has the potential to improve the trial process either by reducing cost or shrinking the timeline should be given a chance. Technologies that were not known 20 years ago are now commonplace in clinical trials. However we also need to remember that healthcare decisions are more complicated and personal than self service options like airline reservations. Participants have lots of questions, many of which can be answered satisfactorily online, or via chat or other technologies. But for others, the only answers that will resonate, are the ones that come from a human voice.
