Comparison of participant characteristics in decentralized clinical trials, conventional clinical trials, and real-world patients: a descriptive study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Compare baseline characteristics of trial participants with real world patients to study the representativeness.

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Diabetes mellitus

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  830000

Study design details

• Main study objective:
  This study’s aim is to describe the differences in baseline characteristics between a decentralized clinical trial and a conventional clinical trial compared to real-world patients (i.e. those who are intended to use the intervention under study, and the eligible patients).
• Outcomes:
  The proportion of participants and real world patients with key baseline characteristics (these will be discussed with a diabetologist) for categorical variables and mean (SD) for continuous variables. We will describe the differences between the trial participants, intended users, and eligible patients for both the decentralized and the conventional clinical trial. Baseline characteristics that were not considered key characteristics or were not reported in both the decentralized trial and the conventional trial (but only in one of these trials) may be explored.
• Data analysis plan:
  We will use descriptive statistics to report on the baseline characteristics. Continuous variables will be described using the mean (standard deviation) and median (interquartile range) and categorical variables will be described by the number and percentage of patients in each category. Participation to prevalence ratios and Cohen's D may be calculated to compare categorical and continuous characteristics, respectively, for the intended users, eligible patients and trial participants. CPRD Gold data will be used that is representative of the UK population.