Nearly half of clinical trial sites do not have enough enrollees however, three-quarters of participants are patients at an investigative site, in part due to the relative ease of generating awareness on-site. Thus reaching potential participants from outside of trial sites is critical for future trial success but also challenging due to industry reliance on traditional media, physician referrals, and the legacy processes of pharma and CROs. Creative methods of generating awareness, including drawing connections to advocacy and support organizations as well as leveraging the reach of the government, will increase cancer patients’ likelihood of investigating their eligibility and seeking input and support from their physician thereby leading to increased enrollment.
Link 1: This industry research report details some of the anticipated changes in clinical trial recruitment. Standalone patient recruitment companies, patient networks and support groups are mentioned as sources for “pushing” – recruiting participants who are not patients at an investigator site – patients into trials. The emphasis is on generating awareness to foster enrollment.
Link 2: Research by the Tufts Center for the Study of Drug Development affirmed that recruitment and retention are among the greatest challenges facing clinical research. They found that most drug sponsors and CROs rely on traditional media and physician referrals which unfortunately has resulted in 37% of sites being under-enrolled and 11% never enrolling a single patient.
Link 3: The ineffectiveness of current recruitment methods is further highlighted in this report. The study found that overall patients either receive too much information about clinical trials from sources they do not want it from, or too little from those that they do want to hear from. And although these 5,700 study respondents had specifically opted-in to receive information on clinical trials only 61% ever had participated in one.
The most significant challenges lay in trying to modify the processes of SSA/DDS. This can be overcome by working with groups that already have been encouraging the government to create a federally sponsored clinical trials awareness campaign as well as with organizations that already know how to effect policy changes at SSA.
Assuming nearly 0.5% of the US population has cancer but only 3% of them are participating in trials then there are nearly 50,000 trial participants. A concerted campaign geared toward the 20,000 monthly SSDI applicants who have cancer can certainly double accrual rates within two years as this would translate to enrolling only a fraction of new applicants, to say nothing of those already pending.
Unfortunately the rate of new SSDI applicants is not going to significantly drop and thus there will be an ongoing pool of applicants to inform.
Partnerships with organizations and programs already closer to the advocacy industry and SSA policy makers.
Historically government programs have been siloed and insular. That is changing in part due to the need for modernization, technology and the Affordable Care Act. Also advocacy organizations simply have never been encouraged to do this type of work before.
