PEDIATRIC TRIALS PROTOCOLS SUBMITTED TO T HE SAINT-ANTOINE-TEACHING-HOSPITAL ETHICS COMMITTEE (PARIS VI, FRANCE)

The 401 opinions issued by the Saint Antoine Teaching Hospital Ethics Committee (Paris) from May 1986 through May 1990 were reviewed retrosp ectively. Of the 343 protocols for trials in adults, 190 (55.4%) were accepted, 125 (36.4%) were accepted with modifications, one (0.2%) was referred to another body for further discussion, and 27 (7.9%) were r ejected. Corresponding figures for trials in children were 58, 30 (51. 7%), 25 (43.1%), 1 (1.7%), and 2 (3.4%). Among pediatric trials, 10 we re double-blind, 28 were simple-blind, and 20 were open-label. Of the 26 comparative pediatric trials, 23 used a parallel-group design and s ix a cross-over design. Nine protocols involved use of a placebo. Ther e were 20 Phase IV trials, 21 Phase III trials, and 10 Phase II trials . Among the two trials for which the committee declined to issue a pos itive opinion, one was a trial without therapeutic benefit in brain-de ad neonates; it was difficult to understand because its protocol was p oorly written. The other was a request for a retrospective opinion on a completed study. Most of the requests for modifications or additiona l information involved informed consent (n = 16), information provided to the child (n = 3), pharmacokinetic data (n = 4), selection criteri a (n = 3), and risks related to the trial (n = 3). Pediatric trials ac counted for one-sixth of all the protocols submitted to the Ethics Com mittee. They were somewhat more difficult to evaluate than trials in a dults. The main problems involved informed consent, pharmacokinetic da ta, selection criteria, and trial-related risks.