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

Table 2 General Reporting Characteristics

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 guidance^a
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 material^a
CT registration^b	21	(47.7)
CT publications including supplementary files	9	(20.5)
Protocol as supplementary file^c	6	(13.6)
CT publication sections and files addressing IC^a
Abstract	18	(40.9)
Methods	41	(93.2)
Eligibility	27	(65.9)
Ethics	34	(82.9)
Results	15	(34.1)
Discussion	1	(2.3)

CT Clinical trial, EC Ethics committee, IRB Institutional review board, NDA No data available, IC Informed consent
^a Numbers do not add up, since several features may apply and some publications were inconclusive in the description
^b 60% of publications since CT registration became a requirement by the ICMJE in 2005 [70]
^c 24% of publications since protocol publication became a requirement by the CONSORT statement in 2010 [17]

ISSN: 1471-2458