Barriers to effective clinical trial enrollment and possible solutions
Patient enrollment forms a critical tenet to an effective clinical trial process. However, such a process is prone to myriad challenges, resulting in increased costs and delays. Pharmaceutical companies and CROs have often embraced three conventional approaches to overcoming these barriers. First, adding study sites is essential in expanding the geographic reach of the potential study subjects. Besides, they have used strategic locations of the relevant adverts, including posters in healthcare settings to reach out to the target audience. Also, CROs and pharma companies have used specialists and general practitioners to generate patient referrals. While the use of these traditional methods has been widespread, their efficacy remains low. Digital techniques provide better alternatives to the traditional approaches, particularly in boosting enrollment for clinical trials.
Approaches to digital patient enrollment
Digital enrollment may involve the use of search engines like Google or social media platforms such as Instagram and Facebook. Search engines use a pay-per-click approach and target a specific audience based on their behavior and demography. It is an essential strategy in leveraging search terms used by potential patients. Similarly, social media targets potential recruits for a clinical study.1 These digital strategies increase not only clinical trial enrollment but also minimize the associated costs.
Digital enrollment strategy during trial start-up
The stakeholders in a clinical trial discuss the enrollment approach, formulate objectives, and the study design. The above details are incorporated into the trial protocol and the consent form, among other documents that must comply with regulatory requirements.2,3 According to the FDA, direct adverts to the potential study subjects mark the beginning of the informed consent process.4 Regulation is key to ensuring high standards and ethical guidelines given the new aspect of digital platforms, particularly in the clinical trial process.1
The second approach entails developing a questionnaire for the target study participants to be filled remotely and digitally. The strategy saves time and labor, thereby enhancing the efficacy of the clinical trial.
The last process involves the assessment of the specific digital enrollment needs of study sites from the start-up to the trial phases. Digital enrollment initiative is more flexible than the traditional approach. Notably, the clinical trial start-up phase enables stakeholders to pinpoint digital enrollment needs, while the study phase provides feedback to adjust the process.
How innovative digital enrollment strategies increase enrollment
The world is witnessing heightened digital transformation across multiple sectors, including a clinical trial, particularly facilitated by the COVID-19 pandemic.5 The innovative digital enrollment approach fosters collaboration between clinical data aggregators and clinical trial sites. The strategy creates an environment facilitated by implementing a universal tool kit. The kit facilitates cooperation between publishers and partners.6 Also, the system contains a digital patient consent management tool compliant with GDPR,7 CFR part 11,8 ICH,9, and GCP.10 The tool utilizes a centrally managed system to enroll patients. Lastly, the system has a patient-focused tool that fosters subjects’ participation in clinical trials by educating them on the necessity. It conforms to the NIH and NSF guidelines on the implementation of digital technologies in clinical trials.11
How Dokumeds can help you increase your digital enrollment rates
Dokumeds offers patient recruitment services through its specialized patient recruitment CRO team member, the Liaison Manager (ELM). The ELM customizes the digital enrollment approaches to specific clinical trials and ensures their success. Also, he liaises with the CRO, sponsor, patients, sites and optimizes digital enrollment through seamless communication and collaboration.
At Dokumeds, we take pride in a strong patient recruitment record and prioritize digital patient enrollment to achieve clinical trial success. We tailor our recruitment services to each project and sponsor and are committed to the success of the clinical trials we undertake.