CLINICAL TRIALS LANDSCAPE FOR DIGITAL HEALTH INTERVENTIONS: A DESCRIPTIVE ANALYSIS
Author(s)
Braileanu G1, Sa'id J2, Higgins C2, Rousseau B2
1Adelphi Values Ltd, Bollington, CHE, UK, 2Adelphi Values Ltd, Bollington, UK
OBJECTIVES : To assess the distribution and design characteristics of clinical trials of digital health interventions (DHIs) across geographies, acute and chronic conditions, and DHI types. METHODS We conducted a comprehensive review of 1,154 ClinicalTrials.gov records between January 2010 and November 2019 reporting on interventional studies. DHIs were defined as any interventions delivered through online, mobile or tablet and video platforms or via remote (wireless) monitoring devices. DHIs could be assessed either alone or in combinations with other interventions. Diagnostic or telephone-based interventions were excluded. No criteria were applied for patient populations. RESULTS A total of 619 records were included in the analysis. Most trials were conducted in North America (N=344) and Europe (N=230). The annual number of registered clinical trials increased from 25 in 2010 to 95 in 2013. The majority of these trials (N=534) were conducted in patients with chronic conditions, most commonly heart failure (7.9%), diabetes (type 1 and 2; 7.8%), chronic obstructive pulmonary disease (5.5%), obesity (4.2%), hypertension (3.5%), cardiovascular disease (3.2%), sleep apnea (3.2%) and pain (2.1%). Only 32 trials of patients with acute conditions were included. Regardless of disease type (acute or chronic), trial designs were more likely to include randomized allocation, parallel group assignment and no blinding. Similarly, when assessed by intervention type (remote monitoring, online-, mobile- video-based), trials most commonly included randomized, open-label, parallel assignment designs. Other common designs for both disease and intervention types included single group assignment and single blinding. CONCLUSIONS Clinical trial designs of DHIs do not vary across disease and intervention types; however, challenges persist with regards to blinding of interventions in multi-arm studies.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PMU95
Topic
Health Service Delivery & Process of Care, Medical Technologies
Topic Subcategory
Digital Health, Telemedicine
Disease
Multiple Diseases