title: The Schistosomiasis Clinical Trials Landscape: A Systematic Review of Antischistosomal Treatment Efficacy Studies and a Case for Sharing Individual Participant-Level Data (IPD).
abstract: Schistosomiasis control mainly relies on preventive chemotherapy with praziquantel (PZQ) distributed through mass drug administration. With a target of 260 million treatments yearly, reliably assessing and monitoring efficacy is all-important. Recommendations for treatment and control of schistosomiasis are supported by systematic reviews and meta-analyses of aggregated data, which however also point to limitations due to heterogeneity in trial design, analyses and reporting. Some such limitations could be corrected through access to individual participant-level data (IPD), which facilitates standardised analyses.
  
  
  
  A systematic literature review was conducted to identify antischistosomal drug efficacy studies performed since 2000; including electronic searches of the Cochrane Infectious Diseases Group specialised register and the Cochrane Library, PubMed, CENTRAL and Embase; complemented with a manual search for articles listed in past reviews. Antischistosomal treatment studies with assessment of outcome within 60 days post-treatment were eligible. Meta-data, i.e. study-level characteristics (Schistosoma species, number of patients, drug administered, country, etc.) and efficacy parameters were extracted from published documents to evaluate the scope of an individual-level data sharing platform.
  
  
  
  Out of 914 documents screened, 90 studies from 26 countries were included, enrolling 20,517 participants infected with Schistosoma spp. and treated with different PZQ regimens or other drugs. Methodologies varied in terms of diagnostic approaches (number of samples and test repeats), time of outcome assessment, and outcome measure (cure rate or egg reduction rate, as an arithmetic or geometric mean), making direct comparison of published data difficult.
  
  
  
  This review describes the landscape of schistosomiasis clinical research. The volume of data and the methodological and reporting heterogeneity identified all indicate that there is scope for an individual participant-level database, to allow for standardised analyses.
authors.affiliation: The Global Heath Network, University of Oxford, Oxford, United Kingdom.|Centre for Global Health and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
authors.forename: Amélie M
authors.identifier: 0000-0003-2605-6726
authors.initials: AM
authors.lastname: Julé
authors.affiliation: Competence Centre for Methodology and Statistics (CCMS), Luxembourg Institute of Health, Luxembourg, Luxembourg.
authors.forename: Michel
authors.initials: M
authors.lastname: Vaillant
authors.affiliation: The Global Heath Network, University of Oxford, Oxford, United Kingdom.|Centre for Global Health and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
authors.forename: Trudie A
authors.initials: TA
authors.lastname: Lang
authors.affiliation: Centre for Global Health and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.|WorldWide Antimalarial Resistance Network (WWARN), University of Oxford, Oxford, United Kingdom.
authors.forename: Philippe J
authors.initials: PJ
authors.lastname: Guérin
authors.affiliation: Centre for Global Health and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.|UNICEF/UNDP/World Bank/WHO Special Programme on Research and Training in Tropical Diseases (TDR), Geneva, Switzerland.
authors.forename: Piero L
authors.initials: PL
authors.lastname: Olliaro
mesh_terms: D000871:Anthelmintics / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012552:Schistosomiasis / Q000188:drug therapy*
chemical_list: D000871:Anthelmintics