Table 2 Characteristics of included trials
From: Failure to report protocol violations in clinical trials: a threat to internal validity?
Trial Characteristics | Percent (number) of Trials |
|---|---|
Study Type | Â |
   Individual patient RCT | 76.25% (61/80) |
   Factorial RCT | 6.25% (5/80) |
   Cluster RCT | 17.5% (14/80) |
Number of study arms | Â |
   Two | 83.75% (67/80) |
   Three | 7.5% (6/80) |
   Four | 8.75% (7/80) |
Patient Population | Â |
   Adults | 91.25% (73/80) |
   Children | 6.25% (5/80) |
   Infants | 1.25% (1/80) |
   Mixed (Adults & Children) | 1.25% (1/80) |
Study Intervention | Â |
   Drug | 46.25% (37/80) |
   Surgery | 8.75% (7/80) |
   Education | 10.0% (8/80) |
   Other | 27.5% (22/80) |
   Procedure | 3.75% (3/80) |
   Weight loss | 3.75% (3/80) |
Funding Source | Â |
   Academic | 73.75% (59/80) |
   Industry | 26.25% (21/80) |
Trial start-up meeting described | 8.75% YES (7/80) |
Trial run-in phase described | 8.75% YES (7/80) |
GCP adherence reported | 6.25% YES (5/80) |
Lead Investigator reports previous research experience | 62.5% YES (50/80) |
Trial results | Â |
   Harm | 2.5% (2/80) |
   Neutral | 32.5% (26/80) |
   Positive | 65.0% (52/80) |
Management structure | Â |
   MC, SC & others (explicit structure) | 26.25% (21/80) |
   MC or SC only (basic structure) | 21.25% (17/80) |
   Not reported | 52.8% (42/80) |