Digital Enrollment In Clinical Trials
By Cyndi Root
In the digital age, clinical trial recruitment is easier but has some drawbacks. Digital processing speeds up recruitment, helps find patients that would not be found through the physician’s office, and can lower recruitment costs. In the Internet age, physician-led recruitment still exists, but digital enrollment is increasing through social media platforms, CRO portals, and agencies like clinicaltrials.gov. An article from HITLAB also discusses some of the ways electronic health record (EHR) recruiting can be used to boost clinical trial enrollment, though patient privacy remains a prominent concern.
Recruitment Challenges
Clinical trial recruiters often have a difficult task of finding appropriate patients. Pharmaceutical companies want to find patients that fit the study criteria, but more importantly, they need to find patients that they expect will benefit from the drug. This selection process increases the likelihood of positive study results, Food and Drug Administration (FDA) approval, and effective marketing of the drug. The focus on the bottom line leads to careful selection of participants in the trial.
Finding patients is not easy as participants are not remunerated, the novel drug is unproven, and they may receive a placebo and not the treatment that they want and desperately need. Some studies are for adults and some for pediatric patients. Studies may be gender based with entire studies devoted to male or female patients, or the FDA may demand subgroup analysis of study results.
Physician-Led Recruitment
A physician broaching the subject of a clinical trial is the standard method of recruitment. However, this depends on the physician’s knowledge of current drug discovery, which can result in a lower rate of referrals.
Agencies
ClinicalTrials.gov is a service of the U.S. National Institutes of Health. It is a comprehensive registry of clinical trials with human participants. The site is informational in scope as patients are given the contact information for the investigators in a particular study so prospective participants can sign-up.
Social Media
Social media outlets, such as Facebook and Twitter, are becoming likely targets for clinical trial recruitment, as for many people, the sites and services integrate into their daily lives. Social media outlets can be used to target appropriate patients or patients can conduct searches to find studies. However, this type of recruiting can be time-consuming, as it involves regularly crafting posts, monitoring the channels, and it can be costly to advertise on these channels.
CRO Portals
Contract Research Organizations (CROs) may offer their assistance in recruiting patients by offering a proprietary platform to digitally capture prospective patients. Outsourced recruiters with digital portals can save time for a pharmaceutical company but they are costly and often require the transfer of intellectual property in order to effect recruiting.
EHR
According to HITLAB, mining EHRs for data to enroll patients in clinical trials has been gaining popularity over the past few years. The patient’s records would exist in a global database that investigators can sift through in order to find relevant patients. However, there are still ownership, consent, and privacy concerns surrounding this process, HITLAB says, which could slow this form of digital recruitment.