OBJECTIVES

: Digital health technologies are gaining an attention among various stakeholders, including healthcare providers, consumers/patients, payers and health industry, as valuable ways to enhance healthcare management efficiencies. However, to successfully reach the market and gain funding, they need to prove their effectiveness as for other health technologies, which may represents a significant challenge due to specificities associated with digital solutions. The study aimed to analyse current trends in clinical trials conducted for digital health solutions.

METHODS

: Clinical trial design for digital health technologies were retrieved from clinicaltrials.gov records. Trials were identified using free search terms “digital health”, “eHealth”, “telehealth”, “telemedicine”, “artificial intelligence”.

RESULTS

: In total, 1317 trials for digital health technologies were identified. The first record for such trial is dated of 1999 and since then, the number of new trials increased exponentially, reaching 218 in 2018. The average enrolment is over 2,300 participants, however the median is 130. Only 9% of trials have development phase assigned, and most often it is Phase 3. The trials are most commonly sponsored by universities, research institutes and medical centres, with pharma/biotech industry being involved only in few trials (3%). Significant majority of studies was launched in the USA (635), totalling to approximately the same as in all other countries together. The most common intervention types are behavioural treatments (41%), devices (17%) and procedures (5%). In terms of trial design, majority of trials is randomized (68%) with parallel group assignment (86%). Blinding was applied to less than half of randomized trials (41%) and often it was single-blinding associated with the outcomes assessor.

CONCLUSIONS

: There is an increasing number of published digital health studies mostly sponsored and conducted by research institution. Funding of digital health technologies will require developers to generate the appropriate evidence to demonstrate their value and to early engage in partnerships with experienced academics/medical centres.