Researchers have enrolled 2,000 people with metastatic breast cancer in 7 months using a social media-enabled, direct-to-patient model of recruiting. The study is using social media and blogs to drive patients to a website where they can consent to share medical records and genomic data with the researchers.
A team from the Broad Institute and the Dana-Farber Cancer Institute set up the study to address the lack of genomic data from the tumors of patients with metastatic breast cancer. This situation is a consequence of many breast cancer patients being treated in community care settings. Faced with this shortfall in knowledge, the researchers designed a study that allows patients to consent to share parts of their tumor biopsies, medical records and saliva samples using at-home spit kits.
The design of the data-gathering elements of the trial free participants from the need to visit a study site. This makes it easier for the researchers to enroll subjects, but only if they can contact patients and persuade them of the value of participating. Like Pfizer ($PFE) before it, the Broad/Dana-Farber team has used social media to enroll subjects in its virtual trial. But, while the approach proved to be flawed for Pfizer’s trial, the strategy pursued by Broad and Dana-Farber is working for its study.
With enrollment topping 1,200 in three months and 2,000 in 7 months, the trial has turned heads. “[This is] incredibly, incredibly rapid enrollment,” Dr. Sumanta Pal, a medical oncologist at City of Hope, said in a statement. Pal, who is not involved in the study, thinks the trial represents a proof of concept for the direct-to-patient approach. “If this paradigm continues to enjoy the success it has thus far, the patient-driven model is something we can implement across disease types,” he said.
Pal’s statement is very different in tone than those made at the end of the Pfizer study, which was axed early because of slow enrollment. Yet the divergence in performance is not primarily to do with the social media aspects of the trials. Pfizer was successful at getting people to its website--perhaps in part because of the high profile of the study--but large numbers of potential participants dropped out at each step of the filtering process.
More than 20,000 people viewed Pfizer’s study introduction website, 1,519 met the inclusion/exclusion criteria but ultimately 8 patients were randomized. The Broad-Dana-Farber team is yet to share a breakdown of numbers for its enrollment funnel, but a lower dropout rate would be unsurprising. Pfizer’s virtual trial was a randomized, placebo-controlled, Phase IV study. The Broad/Dana-Farber effort is a simpler, data-gathering project that asks less of its participants.
- read the poster