“No decision about me, without me” was to be the new standard of thinking for a more patient-centric NHS future, said the UK Government back in 2012. Prioritisation of active patient involvement, however, has undoubtedly lagged in clinical research, where regrettably research is too often deemed to be carried out on patients, not with them. Nevertheless, the proliferation of effective and cost-effective digital technologies, capable of accurately measuring patient health data, finally appear (almost) ready to disrupt clinical trials as we know them.
The past decade of the wellness industry has seen growth concomitant with the expansion of digital devices to track your every metabolic metric and calorie-burning step. Applications of these so-called wearables go far beyond everyday lifestyle micromanagement, as the global pharmaceutical industry slowly gives onus to these technologies; for collecting, measuring, and assessing health data. Such technologies enable patient-centric data generation, that not only means superior trial experience but also helps to get the right patients on treatments they would otherwise miss.
In an article last year for Harvard Business review Antoniu Fantana, Gina Cella, Charles Benson, and Joseph Kvedar, discussed the need for better and continuous data generation to radically improve clinical research, which in essence, they say, hasn’t changed much since the ‘40s. The key processes and principles that we uphold today very much resemble the first randomised controlled of trial of streptomycin in 1946. The authors go on to review the key technologies, and their underlying algorithms, that promise to make drug development smarter, better and faster.
Also used clinically to manage chronic conditions such as diabetes and hypertension, continuomics is the application of technologies to measure an individual’s physiological data in a continuous and unobtrusive manner. Allowing researchers to record participant data including blood pressure, heart rate and various other biomarkers, these devices significantly reduce the number of required physician consultations and hospital visits. Minimising inconvenience and for some patients, removing the anxiety induced by hospital visits, ought to reduce common reasons for preventable dropouts of clinical studies.
Beyond contributing to patient retention, continual monitoring of physiologic parameters, gives researchers a deeper understanding of individual drug response and can often provide an early indication of adverse drug reactions. Traditional medical assessments, usually completed on a weekly basis during clinical studies, means that data is inherently fragmented. Whereas, continuomics offers vastly greater quantities of data collected at variable times points. The result should be data representative of the whole picture, and therefore meaningful evidence of drug efficacy and safety.
Continuomics makes possible virtual trials, allowing patients living far from the study site to participate in trials that, practically, they couldn’t be enrolled on traditionally. Site-less trials are particularly appropriate to rare disease research, where the naturally small size of potential participants would otherwise limit studies. However, unfortunately in reality, complex and more serious diseases are harder to run in virtual trials, explained Sandra Shpilberg, founder and president, Seeker Health by Eversana, “we’re seeing applicability in dermatology, but we don’t see a lot of site-less or virtual trials in cancer or rare diseases.”
The authors conclude that the opportunity that continuomics innovation presents to modernise clinical research and overhaul antiquated methods of data collection, is primarily hampered by both the medical and pharmaceutical communities’ aversion to adopting new protocols. But with consensus from regulatory bodies, including the FDA, it’s hoped the future of clinical trials is not far off.