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Table 2 General Reporting Characteristics

From: Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

Characteristics n (Total n = 44) (%)
CT design
Randomised, controlled (including cluster- and community-randomised) 37 (84.1)
 Control
  Placebo-controlled 12 (32.4)
  Treatment-controlled 24 (64.9)
  No treatment-controlled 1 (2.7)
 Blinding
  Blinded (including double-, single-, and partially-blinded) 21 (56.8)
  Open-label 10 (27.0)
  NDA 6 (16.2)
 Phase
  Phase I 1 (2.7)
  Phase III 3 (8.1)
  NDA 33 (89.2)
Non-randomised, single-arm 6 (13.6)
NDA 1 (2.3)
EC/ IRB approval
By multiple national and external ECs/IRBs (local regulatory authorities, local IRBs, national ECs, international ECs, external national ECs, and external IRBs) 24 (54.5)
By multiple local (local regulatory authorities, local IRBs, national ECs) 1 (2.3)
Only by local EC/IRB 13 (29.5)
Only by national EC 1 (2.3)
NDA 5 (11.4)
Regulatory/ethical guidancea
Good Clinical Practice 13 (29.5)
Declaration of Helsinki 9 (20.5)
National/local regulatory requirements 7 (15.9)
Good Laboratory Practice 1 (2.3)
n/a (Conference abstract) 2 (4.5)
NDA 27 (61.4)
Supplementary materiala
CT registrationb 21 (47.7)
CT publications including supplementary files 9 (20.5)
Protocol as supplementary filec 6 (13.6)
CT publication sections and files addressing ICa
Abstract 18 (40.9)
Methods 41 (93.2)
 Eligibility 27 (65.9)
 Ethics 34 (82.9)
Results 15 (34.1)
Discussion 1 (2.3)
  1. CT Clinical trial, EC Ethics committee, IRB Institutional review board, NDA No data available, IC Informed consent
  2. a Numbers do not add up, since several features may apply and some publications were inconclusive in the description
  3. b 60% of publications since CT registration became a requirement by the ICMJE in 2005 [70]
  4. c 24% of publications since protocol publication became a requirement by the CONSORT statement in 2010 [17]