A senior Pfizer R&D executive is calling for clinical trials to make better use of the phenomenon of the “empowered e-patient” – but admits that highly interactive e-patients can pose challenges to the data collection process.
“While there is not always much room to innovate [within trials], there are ways to partner with e-patients to improve awareness, assist with recruitment and retention, report outcomes, and share data and learnings,” Craig Lipset, senior director, clinical research at Pfizer, told a packed room of delegates at the e-Patient Connections conference in Philadelphia this morning.
Lipset believes there are a couple of things that can be done immediately. “First, we need to make clinical trials more patient-centric and less investigator-centric,” he said, explaining that the conventional wisdom of centering investigations around trial centers effectively creates “hub-and-spoke models” that can restrict the scope and scale of studies. (“Could patients participate from home or use their mobile phones?” he asks.)
Second, Lipset suggests that trials could become more participatory by sharing data and learnings with subjects, which could, in turn, improve patients’ experiences and outcomes. He cited the example of making bloodwork data from the trials available to the participants’ own physicians, which, at the very least, might save patients the expense of paying for it again. Lipset also believes in sharing the study results with patients.
“Anyone who shares their body in a trial,” he said, “should get the learnings back.”
Lipset warned, however, of the potentially adverse effects of working with a group of highly interactive, empowered patients in a blinded, randomized study because they might share observations about adverse events or discuss which group they might be in. “We can’t stop those conversations,” he said, “but we need to understand them as they affect how we interpret the data.”
According to Lipset, Pfizer is having internal discussions about a number of possible initiatives for integrating, utilizing and exchanging value with empowered patients during clinical research.
