This is an era of change. For the last five decades, computational power and capabilities have increased and evolved in an unprecedented manner. Clinical trials are the central mechanism for unbiased assessment of proposed advances in health, healthcare, and evaluation of approaches to prevention, diagnosis, and treatment of disease. The digital health era now offers tools for transforming clinical research through improved efficiencies of highly complex trials. Leveraging digital technologies will be instrumental in accelerating clinical evidence generation on a global level.
Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs, medical devices, and other therapeutic interventions. Today, the conduct of clinical trials continues to rely heavily on the use of paper documents. For example, participant recruitment, informed consent, and the collection of source data are still performed manually, often in paper format. Thus, it is time to fundamentally shift the traditional paradigm as the current methods for conducting clinical trials are no longer sustainable. New strategies for the future of clinical trials are needed, including the concept of digital clinical research. Digitally enabled tools will help to improve participant access, participant engagement, trial-related measurements, and interventions. More and more aspects of conducting clinical trials — e.g., remote patient monitoring via telemedicine — and other decentralized ways of collecting data will then be managed electronically and automatically.1
The digitization of modern life began with the personal computer, then accelerated with the emergence of the Internet and the rapid uptake of mobile devices. Initially, life science and healthcare industries were reluctant to embark on the transformative activities made possible by the rise of these technologies and what is now the backbone of what is called digital clinical evidence generation.2 The hesitation to act on digitization and data stores had validity, particularly because of concerns relating to personal health information and regulations such as the Health Insurance Portability and Accountability Act and the European Union’s legislation on data protection, such as the Data Protection Directive and the General Data Protection Regulation.3,4
Yet while privacy and security concerns must be addressed, in clinical research the use of new technologies like artiﬁcial intelligence that support the identiﬁcation of meaningful relationships in raw data and the extraction of relevant insights must be increased. By supporting physicians to make more informed clinical decisions, digital clinical evidence generation provides unprecedented development opportunities for all ﬁelds of healthcare, including drug and medical device development. This will create signiﬁcant beneﬁts that will reshape not only processes relevant for Fresenius Medical Care’s global clinical research but also — and most importantly — patient care in general.
The rapidly accelerating adoption of mobile, self-serve diagnostic, monitoring, and treatment modalities (or mHealth) in both the healthcare and clinical trial arenas is already demonstrating a material impact on healthcare delivery.5 By capturing timely and high-quality data remotely, at-home wearable devices provide the dual beneﬁt of reducing both investigator and participant burden, for example, by reducing the frequency and duration of clinical visits (Figure 1).6
FIGURE 1 | As the use, reliability, and confidence in digital tools and electronic data management systems increase, such systems will be further introduced into clinical trials.
Taken a bit further, digital technology permits continuous real-time monitoring of participants’ well-being during and after clinical trials. This will boost the process of collecting data and will drastically increase insights into patient health and compliance, as well as safety and effectiveness of the therapy in question. Digital mHealth tools enable the swift, secure collection of large volumes of accurate and consistent data on which further analysis can then be performed on the spot, such as comparing therapies and assessing efficacy.7,8,9
These days, many clinicians are dispirited by the numerous repetitive practices required in conducting clinical trials. If digital data sources were to be fully used, many of those repetitive practices would be unnecessary. It is important to note that all stakeholders, including health authorities, have a great interest in clinical trial optimization. As an example, consider the US Food and Drug Administration’s (FDA) “Voice of the Patient” program, which aims to “systematically gather patients’ perspectives on their condition and available therapies to treat their condition.”10
While the adoption of mHealth will require transforming study teams to a new and different way of working, the digital technologies will improve trial efficiency by enhancing and supporting the role of investigators and study staff. Fresenius Medical Care will be moving toward a participant-centered clinical trial experience by minimizing geographic obstacles for participation and establishing a high level of connectivity with participants and investigators. This allows for the possibility of individual ﬁndings and overall results to be returned repeatedly to participating investigators throughout the duration of the study, thus fostering a true partnership in clinical research. mHealth will help shape a more personalized, more precise, and more supportive clinical research environment.
Traditionally, Fresenius Medical Care’s clinical trials have been largely limited to North America and certain countries in Western Europe. The introduction of global digital clinical trials represents enormous potential in various areas, including streamlining operational costs, increasing speed and agility, and enhancing the diversity of clinical participants. Today, there is an enormous opportunity to harness digital technology to expand research activities geographically and concurrently to accelerate the pace at which evidence through clinical trials can be generated.11,12,13,14
However, this cannot be accomplished by replicating the current research processes and simply transforming them from paper to digital form. Rather, a complete rethinking and reengineering of the clinical trial concept around the participant and the clinical site is needed. While some trials could be conducted digitally in a virtual environment, many will require a hybrid of virtual and clinical site-based activities. Future digital clinical trial concepts will use micro-randomization to build and optimize individual intervention components within just-in-time adaptive interventions. These mHealth technologies aim at delivering the right intervention components at the right time and location to optimally support individuals’ health behaviors.15,16,17,18,19,20,21
Finally, the harmonization of pharmaceutical regulations is essential to transform the traditional concept of clinical trials. Signiﬁcant progress on regulatory convergence has been achieved to date by agreements and close collaboration between regulators like the FDA and the European Medicines Agency. Much effort is still needed before a fully global harmonization can be realized.22,23,24
Medicine today primarily focuses on treating disease; in the future, it will increasingly be used to prevent disease. A dramatic transformation of the global clinical trial operational delivery model is under way, driven by ever improving digital clinical technology in a more harmonized regulatory environment. Fresenius Medical Care’s global clinical research team is prepared to responsibly and creatively adopt digital technologies to create efficiencies in a way that preserves the strength of classical clinical trials. There is ample evidence of the beneﬁts of mHealth.
Correspondingly, digital tools will improve clinical trial designs, yield data of higher quality at lower cost, and accelerate Fresenius Medical Care’s product development cycle times. This will ultimately permit an accelerated release of new products and therapies that improve the health of individuals living with kidney disease and provide more advanced treatment options for healthcare professionals.