title: Evaluation of clinical trials of immunomodulators for prevention of recurrent respiratory infections in children.
abstract: Despite numerous clinical studies showing "significant differences" in favour of immunomodulators versus placebo in the treatment and/or prevention of recurrent respiratory tract infections, the efficiency of such treatments is still not readily acknowledged by a large part of the medical profession nor by governmental authorities in several countries. In an effort to analyze the causes of this scepticism we performed a retrospective study of 15 clinical trials, using a series of quality assessment criteria. From the results of our analysis we propose a series of recommendations for improving the quality of clinical trials with immunomodulators. Furthermore, in order to avoid suspicion of a publication bias, we recommend setting up a registry of all ongoing clinical studies with immunomodulators.
authors.affiliation: Unité de Recherches Biomathématiques et Biostatiques de l'INSERM, Faculté de Médecine Saint-Antoine, Université Pierre et Marie Curie, Paris, France.
authors.forename: A J
authors.initials: AJ
authors.lastname: Valleron
authors.forename: A
authors.initials: A
authors.lastname: Grimfeld
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D015982:Bias; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003469:Culture; D005069:Evaluation Studies as Topic; D006801:Humans; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000517:prevention & control*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic