Unlocking digitally enabled research in oncology: the time is now

M.A. Franzoi1 ∙ E. Gillanders1 ∙ I. Vaz-Luis1,2

Extraordinary advances in cancer screening, therapeutics, and supportive care have contributed to substantial progress in survival rates among patients with cancer over the last 50 years.1-4 Clinical cancer research trials represent the main avenue to foster this progress, allowing discoveries to be translated into patient benefit.

In a recent analysis of pivotal oncology trials from 2015 to 2017, the estimated median trial cost was $31.7 million.5 Costs per patient for oncology phase III trials have increased from an average of $3000 to $5000 in the early 1990s to up to $125 000 in 2013.6 While these figures include both operational and regulatory costs, Sertkaya et al., using aggregate clinical trial budget data provided by Medidata Solutions, found that administrative staff costs accounted for ∼11%-20% and site monitoring accounted for 9%-14% of overall study costs across phases I through III of clinical trials ranging from 2004 to 2012.7 Global phase III trials are often slow moving (e.g. a very successful large phase III trial operation involving 8381 patients took almost 4 years from trial submission to last patient inclusion)8 and time consuming (studies usually require >200 h of work per patient, with a third of time devoted to non-clinical tasks)9 which creates substantial burden for clinical sites and practitioners, and concentrates clinical trials in a selected number of equipped cancer centers. Additionally, <10% of patients with cancer enroll in clinical trials and current clinical trial workflows are non-inclusive; restrict participant access; and often exclude elderly patients, patients living in rural areas, and patients belonging to an ethnic minority or lower socioeconomic group.10,11 For example, although these demographic groups represent almost one-third of the cancer patient population in the United States, only 4%-6% of trial participants are black, and 3%-6% are Hispanic.12

The widespread use of digital technology may offer clinical cancer research an opportunity to innovate and move away from an often exceedingly expensive, slow-moving, burdensome, and unequal research apparatus.13

Cardiology has pioneered the use of digital technology to facilitate clinical trials. For example, a 2019 study led by the Stanford Division of Cardiovascular Medicine was conducted to assess the use of Apple smartwatches to identify atrial fibrillation using a fully decentralized and digitized pathway.14 For instance, researchers used an app to obtain consent and to educate and guide participants throughout the study, patient monitoring occurred through the use of the Apple Watch sensor, and patients were prompted to initiate a telemedicine visit directly from the app upon the receipt of an irregular pulse notification.14 The study was able to recruit 419 297 patients within 8 months from all 50 US states and found that among patients who received an irregular pulse notification, 34% had atrial fibrillation and 84% had electrocardiogram (ECG) patch readings that were concordant with atrial fibrillation.14

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