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Table 2 Characteristics of the 110 Trials Included in this Review, Stratified by Type of Journal

From: A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

Parameter Pediatric Journals (n = 42) General Journals (n = 68)
Design   
   Parallel 40 (95) 68 (100)
   Cross-Over 2 (5) 0
Factorial Trial 0 7 (10)
Cluster Trial 3 (7) 3 (4)
Noninferiority or Equivalence Trial 4 (10) 8 (12)
Centre   
   Multicentre 26 (62) 58 (85)
   Participants in more than one country 8 (19) 21 (30)
Funding   
   Pharma only 10 (24) 15 (22)
   Pharma and Institutional 3 (7) 9 (13)
   Institutional only 24 (57) 44 (65)
   Unclear 5 (12) 0
Participants   
   Neonates 23 (55) 17 (25)
   Infants/Toddlers (<24 m) 11 (26) 27 (40)
   Child (2-11 y) 14 (33) 34 (50)
   Adolescents (11-18 y) 9 (24) 35 (51)
   Adults 1 (2) 28 (41)
Category of Main Disease*   
   Neonatal 22 (52) 9 (13)
   Endocrine, nutritional and metabolic 6 (14) 3 (4)
   Infections 2 (5) 16 (23)
   Vaccine trials 3 (7) 14 (20)
   Respiratory 3 (7) 7 (10)
   Cancer 0 5 (7)
   Other 6 (14) 14 (21)
Setting   
   Outpatient 16 (38) 40 (59)
   Inpatient 5 (12) 12 (18)
   Intensive Care 21 (50) 16 (23)
Type of Interventions   
   Drug 24 (57) 56 (82)
   Invasive 6 (14) 5 (7)
   Other 12 (29) 7 (10)
Number of study groups   
   2 arms 38 (91) 55 (81)
   >2 arms 4 (9) 13 (19)
Use of Placebo or Sham arm 18 (43) 35 (52)
Duration of Intervention   
   Adequately reported 36 (86) 67 (97)
   <1 month 23/36 (64) 35/67 (52)
   1-12 months 11/36 (31) 21/67 (31)
   >12 months 2/36 (5) 11/67 (17)
Planned Power Calculation 31 (74) 61 (90)
Number of Participants   
   Median [IQR]# 136 [50-400] 601 [215-2360]
   <50 11 (26) 0
   50-200 14 (33) 15 (22)
   200-1000 9 (21) 25 (37)
   >1000 8 (19) 28 (41)
Survival Outcome (primary or secondary) 19 (45) 37 (54)
Time to Primary Outcome   
   Adequately reported 28 (67) 57 (84)
   <1 month 15/28 (54) 15/57 (26)
   1-12 months 11/28 (39) 28/57 (49)
   >12 months 2/28 (7) 14/57 (25)
Recruitment Length   
   Adequately Reported 35 (83) 65 (96)
   Median [IQR] months# 30 [21-38] 29 [22-48]
  1. N (%) unless otherwise stated
  2. †Each category is coded separately, so total may either exceed or not add up to 100%.
  3. *Adapted from the ICD-10 Disease Categories
  4. #IQR: Inter Quartile Range