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A look at the evolution of clinical trial recruitment, challenges the industry still faces, and how it can use automation to enhance enrollment efforts.
Subject recruitment remains a big topic in clinical trials. The clinical trial recruitment industry has changed for the better; however, these changes have also come with their own sets of challenges. In this article, I will discuss the clinical trial recruitment industry evolution, the challenges this evolution has imposed on study sites, and how Sponsors can leverage automation and technology to enhance clinical trial recruitment and enrollment efforts from external sources.
The early days of clinical trial recruitment involved relying on selecting sites that had patient populations in their patient base that fit a study's inclusion/exclusion criteria , and additional study promotion included letters to other physicians and flyers. More advanced recruitment methods included television and radio ads. This approach was successful during the Big Pharma blockbuster days when markets for therapeutic indications were wide open without many competitive medical products (making clinical trial inclusion/exclusion criteria relatively broad); in other words, obtaining a high volume of patients would likely result in a higher number of enrolled subjects because study design was less stringent.
Nowadays, sponsors have to compete in an overcrowded clinical trial arena to find the right subjects for their highly targeted and stringent study designs. Some Sponsors that target rare diseases are partnering with nonprofit organizations and patient advocates, whereas most are leveraging electronic medical records (EMRs), and search technologies to query patient data to forge better-targeted protocols, as well as to generate patient referrals from sources internal to study sites -- and such methods are effective.
For recruitment from external sources, sponsors have relied heavily on social media and online ads with precise targeting methodologies. While such methods generate more targeted patient profiles for a better return on investment (ROI), the approach comes with its challenges, which often burden study sites.
While external online sources are great at generating many patient leads targeted to a study's inclusion/exclusion criteria, the method often results in several challenges:
Figure 1 visualizes this process.
Combining these challenges results in recruitment advertising investments going to waste.
Figure 1: Issues with External Recruitment Activities and Efforts
In my experience, I've found that automation (and some thought in execution) can be incorporated to improve the efficiency of processing leads and enhancing the chances of enrollment. Many customer relationship management (CRM) technologies exist today and are relatively inexpensive for study sites and sponsors to use when processing patient leads.
The most significant benefits CRM technologies offer are the ability to automate communications and organize leads for easy processing. For example, when a lead is generated from online sources, they integrate directly into a CRM, which automatically sends text messages and emails, and has calling and voicemail drop functionalities to ease the burden on coordinators. Sending more information regularly to patients before calling them makes them more aware of the study and prepared to take a phone call from a research coordinator. A useful tip includes recording the PI's voice on voice mail drops for better patient engagement.
Ditching the online pre-screening questionnaire is a good idea, as they don't offer much value, to begin with, as they burden patients, are inaccurate, and are often repeated during phone pre-screens. Dropping the online prescreeners helps facilitate more leads for phone pre-screens. Figure 2 illustrates this process. Incorporating automation in processing recruitment leads results in:
Figure 2: Automation in Lead Generation to Screening
New methods of external recruitment have significantly improved the productivity of finding more targeted patient leads during clinical trial recruitment. However, utilizing antiquated procedures to process patient leads is not compatible with the volumes that novel recruitment methodologies generate. Equipping study sites and recruitment personnel with innovative CRM technologies enables them to improve their efficiency in a way that matches novel recruitment procedures.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.