Table 2.
Characteristics of included trials
| Trial Characteristics | Percent (number) of Trials |
|---|---|
| Study Type | |
| Individual patient RCT | 76.25% (61/80) |
| Factorial RCT | 6.25% (5/80) |
| Cluster RCT | 17.5% (14/80) |
| Number of study arms | |
| Two | 83.75% (67/80) |
| Three | 7.5% (6/80) |
| Four | 8.75% (7/80) |
| Patient Population | |
| Adults | 91.25% (73/80) |
| Children | 6.25% (5/80) |
| Infants | 1.25% (1/80) |
| Mixed (Adults & Children) | 1.25% (1/80) |
| Study Intervention | |
| 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 | |
| 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 | |
| Harm | 2.5% (2/80) |
| Neutral | 32.5% (26/80) |
| Positive | 65.0% (52/80) |
| Management structure | |
| 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) |
Abbreviations: RCT - Randomised controlled trials; MC - Management Committee; SC - Steering Committee; GCP - Good Clinical Practice.