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International Clinical Trials

European Union

Several aspects indicate that the time is ripe for a disruptive change in the patient enrolment process to increase clinical trial efficiency. The traditional system of recruitment is both time-consuming and cost-intensive, yet ineffective. It is not as if trial sponsors and CROs are not responding to this challenge – but their answer has been far from ideal, as it primarily involves strategies to expand the number of research sites across multiple geographies, which further adds to the complexity issue and fails to pursue the original goal of optimising the recruitment process.

Moreover, as therapies target niche populations, regulatory agencies are introducing stringent norms for trial sponsors to conduct larger and longer studies. The situation is even worse for clinical trials that call for the treatment of naïve 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 enrolment targets, and 10% of them are unable to recruit a single patient for the study.

Data-Driven Approach

Within the industry, there is a lively, ongoing discussion 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 this kind of system cannot be underestimated; however, this will be a long-drawn out process considering the significant disparities among countries in regulating security, privacy and interoperability, among various other aspects.

In the EU, for instance, there are many countries that do not have a specific law defining the use of health data for clinical research purposes. The majority of the member states are still in the process of establishing a national electronic health records (EHR) scheme, and lack the legal and technical framework to achieve interoperability standards. The EU level initiative to develop an Electronic Health Records for Clinical Research platform to connect EHR systems in different countries, and enable cross-border transfer of data, is going to be a long-term solution. The real answer for the near future lies in leveraging the internet and exploiting social media, patient networks, patient advocacy groups and digital media to recruit patients with previously unimaginable speed and precision.

Research Kit Platform

Apple created a revelation in 2015 with the launch of the Research Kit, 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 Research Kit, which received more than 11,000 responses from patients in a single day. To date, more than five apps have been created using the Research Kit with 100,000 patients enrolling for clinical research studies in six months.

Moreover, researchers are able to monitor patient adherence to activities via smartphones, which reduces false reporting – a major issue witnessed in conventional clinical trials. As with other methodologies, digital recruitment comes with its own set of challenges; however, many of these can be addressed by developing a patient-centric solution that is easy to use and has a responsive design. A poorly created application will be detrimental to the research process and, therefore, developers should focus on interactive solutions with questions posed in the patient’s language.

Online Enrolment

Recruiting patients online should be backed by a wellthought- out approach that uses best practices in various aspects such as marketing, communication and patient education. The concept of eRecruitment is at its nascent stage, but there are ample success stories that have clearly demonstrated that with the right strategy, enrolment targets can be achieved in a cost-effective manner.

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Srikanth Venkataraman is an Industry Analyst for the Transformation Health Practice at Frost & Sullivan. He has more than five years of experience in market research and consulting, and holds a Master’s in International Business from the University of Wollongong, Australia, and a BSc in Electronics and Communication Engineering from Anna University, India.
Srikanth Venkataraman
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