Contributed Commentary By Estelle Haenel 

April 3, 2020 | Although clinical trials are meant to cover global populations, the pool of patients currently enrolled in clinical trials is not representative of world populations. The vast majority of patients recruited in clinical trials undoubtedly comes from the European Union and North America. Rising costs and complexity in clinical research have led to an intensification of protocol inclusion/exclusion criteria that make clinical trials inaccessible to most people. In order to broaden the recruitment of patients enrolled in clinical trials, clinical research opportunities in remote areas must be increased. The inclusion/exclusion criteria should be made more flexible and regulatory requirements ought to be harmonized by the competent authorities. Today, clinical trials are not conducted in a format that secures full representation of people and their cultural differences.  

Technology Enables Clinical Trials Awareness 

The Internet has been instrumental in providing patients with access to scientific and medical information, enabling as many as four in five Americans to have heard about clinical trials. To extend the ethnic and cultural diversity of patients, entering clinical trials starts with developing patient awareness. The Internet is one of the fastest mediums for communications outreach, and thus could be efficient in raising awareness of clinical trial developments in sought-after study locations in emerging markets: EMEA, South America and Eastern Europe.  Information on clinical trials could be provided by sponsors enriching the medical information that is already published via academic structures and patient associations. This would make available a sufficient level of information in those locations enabling patients to become aware and, eventually, make more informed decisions about participating in a clinical trial.  

When sponsors digital platforms allow two-way communication, potential patients can make online enquiries and receive responses to their concerns. This qualitative option in the information process likely leads to a quantitative improvement in the volume of people being made aware and an overall increase in their level of knowledge. 

Besides the Internet, patient-facing technologies, such as smartphones and other mobile devices, are already in use and achieving success in disseminating clinical trial information to broader populations. A research study conducted in 2019 on the use of patient-facing technologies in clinical trials found that respondents (pharma reps, CROs, sites and independent consultants) felt “the use of patient-facing technologies helped widen the pool of trial participants, increase retention, improve the quality of data and improve the overall patient experience.”  

Patient-facing Technologies Expand Recruitment From Remote Locations 

Patient recruitment remains a critical issue, approximately 30% of sites under-enroll and 11% of sites don’t enroll at all. A 2013 survey showed that distance from a physician’s practice to the nearest clinical trial site was inversely associated with a physician’s referral and recruitment, and as such is a true barrier to patient enrollment.  

Mobile communications have helped overcome the hurdle that this distance represents in patient recruitment in clinical trials. The impact of distance has been minimized thanks to the technological evolution of transportation modes. The emergence of transportation apps such as UBER and their globalization has indeed made private transportation more accessible, even in remote areas where alternative transportation services are emerging. 

Other digital technologies have helped in patient enrollment. Electronic Informed Consent (eICF), Electronic Data Capture (EDC), electronic Clinical Outcome Assessment (eCOA), and connected medical devices are digital solutions that work in increasing enrollment of patients from remote areas and from various countries. As they enable remote data collection and direct data streams, these solutions allow patients to contribute to clinical research in their own time at their own locations. Conducting clinical trials in developing countries or remote sites, where Internet is available but travel to sites may be challenging, then becomes possible.  

The Internet and digital tools such as e-learning can also help in making remote sites qualified for clinical trials by expanding communication and training opportunities to distant hospitals and clinics. Virtual meetings and learning opportunities can also help reduce training costs. By saving on travel expenses,  more budget can spent on hiring experienced people; this is paramount to building robust clinical research site teams, as Kate O’Brien, an experienced clinical site research nurse in the UK, observed: “I found it impossible to attract experienced research staff on the salary I was permitted to offer.”  

Nevertheless, while digital tools can help qualify remote sites, it also requires that traditional academic nursing education programs evolve to include robust technological training to embrace the digital transformation. 

Decentralized Clinical Trials (DCTs) As A Solution To Conduct Truly Global Clinical Research

The next generation clinical trials go undoubtedly with the technological evolution that represent DCTs. Sponsors and Clinical Research Organizations (CROs) have begun partnering with sites to take a hybrid approach to conducting clinical trials by participating in decentralized clinical trials (DCTs)—also referred to as virtual trials—in which some study visits are conducted remotely. Remote visits take place in the comfort of the patient’s home and can be completed by using mobile technology that both sites and patients can access from a designated mobile phone or computer. “Through adopting services such as direct-to-patient shipping and remote nursing services, we are seeing more and more clinical trial activities moving from being conducted at the site to being conducted at the patient’s home,” says Dan Milam, VP of Global Engagement at the Society for Clinical Research Sites.  

Virtual trials bring clinical trials to patients. DCTs are just emerging and require deep changes in the well-established rules of conducting clinical trials. They entail risks which are yet to be controlled such as patient compliance at home and the variability of a patient’s technological experience which may limit their implementation in some patient populations. However, DCTs create a unique opportunity, where the distance from a patient’s home to a clinical site, the transportation costs and logistics and access to remote areas are no longer barriers to the global expansion of clinical trials. 

Although we are still in the early stages of digital transformation, technology undoubtedly enables clinical trials to be run in a more global manner. Challenges must be faced as the digital shift entails complexity of logistics, variation in patient attitude towards technology and qualification of clinical sites and sites staff in remote areas. Innovation is here and is key. But the future of clinical research requires openness and collaboration, where innovation will need to coincide with a change in culture.  

Estelle Haenel is Medical Director at Kayentis. Her career spans 25 years in the pharmaceutical industry in preclinical and clinical research. She has worked for both biotech and big pharma. She joined Kayentis as medical director in 2019 from Pfizer, where she spent seven years. Ms. Haenel has led projects from phase 1 through 4 in multiple therapeutic areas and provided guidance and expertise in clinical science and clinical operations. She earned a PharmD from Paris V René Descartes University in 1994 and a Ph.D in Molecular and Cellular Biology from Sud University in 2000. She has published several scientific papers. She can be reached at ehaenel@kayentis.com.