The traditional approach to patient recruitment for global clinical trials is time consuming, cost intensive, and ineffective. Trial sponsors and clinical research organizations (CRO) are responding to this challenge; however, the response has been far from ideal as it primarily involves strategies to expand the number of research sites across multiple geographies, adding to the complexity and failing to optimize the recruitment process. Moreover, as therapies target niche populations, regulatory agencies are introducing stringent norms for trial sponsors to conduct larger and longer trials. The situation becomes worse, particularly for clinical trials that call for treatment-naive patients, which dramatically shrinks the patient pool available for studies. Industry experts estimate patient recruitment to account for one-third of the total time spent on clinical trials. Additionally, 37% of research sites fail to meet their enrollment targets, and 10% fail to recruit a single patient for the study. Furthermore, the delay in drug development because of ineffective patient recruitment results in trial sponsors incurring significant operational and lost opportunity costs. All these factors indicate the time is ripe for a disruptive change in the patient recruitment process to increase the efficiency of clinical trials.
Within the industry, a lively discussion is ongoing about the need for a data-driven approach to use existing health data for clinical research purposes, including patient recruitment. The long-term benefits of a data-driven approach cannot be undermined; however, this process is long, considering the significant disparities among countries in regulating various aspects such as security, privacy, and interoperability. For instance, in the European Union (EU), many countries do not have a specific law defining the use of health data for clinical research purposes. Most countries are still in the process of establishing a national electronic health records (EHR) scheme and lack the legal and technical framework to ensure archiving interoperability standards. The EU-level initiative to develop an EHR for clinical research (EHR4CR) platform to connect EHR systems in different countries and enable the cross-border transfer of data will be a long-term solution. The real solution for the near future lies in leveraging the Internet and exploiting social media, patient networks, patient advocacy groups, and digital media to recruit patients at an unimaginable speed and precision.
Apple created a revelation in 2015 with the launch of the ResearchKit, an open-source platform targeted at trial sponsors and clinical investigators to develop apps specific to therapeutic areas and clinical research studies. The University of California launched an application for a cardiovascular study using the ResearchKit, which received more than 11,000 requests from interested patients in a single day. To date, more than 5 apps have been created using the ResearchKit, with 100,000 patients enrolling in clinical research studies in 6 months. Moreover, researchers can monitor patient adherence to activities through iPhones, which reduces false reporting, a major issue witnessed in conventional clinical trials. As with other methodologies, digital recruitment has its own challenges; however, many of these challenges can be addressed by developing a patient-centric solution that is easy to use and has a responsive design. A poorly developed application will be detrimental to the research process; therefore, developers should focus on interactive solutions with questions framed in the patient’s language. Recruiting patients online should be backed by a well-thought-out approach that uses best practices in various aspects such as marketing and communication and patient education. The concept of eRecruitment is at its nascent stage, but ample success stories clearly demonstrate that with the right strategy, enrollment targets can be achieved in a cost-effective manner.
