title: Can systematic reviews contribute to regulatory decisions?
abstract: BACKGROUND
  The new call on independent research on drugs issued in October 2016 by the Italian Medicines Agency (AIFA) explicitly reported that proposals based on systematic reviews were not admissible, and no justification or explanation for this choice was given. Prompted by this policy decision, here, we briefly discuss the potential usefulness of systematic reviews in responding to regulatory needs. First, systematic reviews, by collecting, analysing and critically appraising all relevant studies on a specific topic, may be used by different stakeholders as a basis for making clinical and policy recommendations, including regulatory recommendations. Second, systematic reviews may advance knowledge as primary clinical research does. Third, systematic reviews may be particularly useful to detect signals of unknown adverse effects. Fourth, systematic reviews may be used to identify knowledge gaps.
  
  
  METHODS
  Systematic reviews may simultaneously produce new findings and summarize existing knowledge, with the potential of informing regulatory decisions more pragmatically and more rapidly than other research designs. We suggest that national and international calls on independent research on drugs should not put primary clinical research against systematic reviews, as it implies a focus on the methods instead of on the questions being asked. As most calls only broadly define the research areas and the topics to be covered, we argue that it should be up to the applicant to make a proposal on which design provides the most valid and useful answer, and up to the assessors to carefully check the validity, feasibility and relevance of such a proposal.
authors.affiliation: WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Policlinico GB Rossi, Piazzale Scuro 10, 37134, Verona, Italy. corrado.barbui@univr.it.
authors.forename: Corrado
authors.initials: C
authors.lastname: Barbui
authors.affiliation: Department of Epidemiology, Lazio Region, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Addis
authors.affiliation: Cochrane Drugs and Alcohol Group, Department of Epidemiology, Lazio Region, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Amato
authors.affiliation: Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Lazio Region, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Traversa
authors.affiliation: IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Garattini
mesh_terms: D007558:Italy; D007880:Legislation, Drug
keywords: Meta-analysis; Regulatory science; Systematic reviews