Table 2

European Medicines Agency (EMA) 2008 priorities for pharmacokinetic (PK) analysis

Name of medicine	Notes	Investigated in trial records identified on the International Clinical Trials Registry Platform search portal?	Still in 2009 EMA priorities?	Still in 2010 EMA priorities?	Medicine investigated in trials without collection of PK data?	In how many trial records?
6-Mercaptopurine	In infants	Yes	Yes	No
Actinomycin	Below the age of 6 years	Yes	No	No
Asparaginase	In infants	Yes	No	No
Baclofen		Yes	No	No
Bumetanide		No	No	No	No
Carboplatin	Below the age of 3 years	No	No	No	Yes	10
Cladribine		No	No	No	No
Clindamycin		No	Yes	Yes	No
Clonidine		No	Yes	Yes	Yes	6
Cyclophosphamide	Data on PK of metabolites	Yes, including metabolites	No	No
Cytarabine	In infants	Yes	Yes	No
Daunorubicin	In infants	Yes	Yes	Yes
Ethosuximide		No	Yes	Yes	No
Foscarnet		No	No	No	No
Glibenclamide	Above 6 years and adolescent	No	Yes	Yes	No
Hydrochlorothiazide		No	No	No	No
Ibuprofen	Parenteral formulation	No^*	Yes	Yes	Yes	1
Itraconazole		No	Yes	Yes	No
Levamisole		No	No	No	No
Meropenem	Below 3 months of age	No	No	No	No
Metformin	In children above 6 years with DM II and in small-for-gestational-age children with precocious/early/rapidly progressing puberty	No	Yes	Yes	Yes	2
Midazolam		No	No	No	Yes	4
Milrinone		No	Yes	Yes	Yes	2
Oxybutynin		No	No	No	No
Propranolol		No	Yes	Yes	Yes	2
Temozolomide	In children particularly below the age of 3 years	Yes	No	No
Topotecan		Yes	Yes	Yes
Unfractionated heparin		No	Yes	Yes	Yes	2
Percentage ‘Yes’		9/28=32%	14/28=50%	12/28=43%	8/19=42%

This table shows which of the medicines that were identified as a priority for PK evaluation by the EMA in 2008 were found to collect PK data in our study sample. We also assessed whether these medicines were still present in the EMA 2009 and 2010 priority lists. Lastly, we searched titles of all 1081 trial records in our sample to assess for which EMA priority medicines trials were conducted without PK data collection (or it was not denoted in the record).
* One trial investigated ibuprofen pharmacokinetics, but in oral formulation.
DM II, Diabetes mellitus type II.