Related Experiment Video
Updated: Mar 9, 2026

Operant Protocols for Assessing the Cost-benefit Analysis During Reinforced Decision Making by Rodents
Published on: September 10, 2018
Can systematic reviews contribute to regulatory decisions?
Corrado Barbui1, Antonio Addis2, Laura Amato3
1WHO 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.
Systematic reviews are valuable for regulatory needs, advancing knowledge, detecting adverse effects, and identifying research gaps. They should be considered alongside primary research in drug development funding calls.
Area of Science:
- Pharmacovigilance and Drug Regulation
- Evidence Synthesis and Research Methodology
Background:
- A 2016 Italian Medicines Agency (AIFA) call excluded systematic reviews without justification.
- This policy prompted a discussion on the utility of systematic reviews for regulatory purposes.
Purpose of the Study:
- To discuss the potential usefulness of systematic reviews in meeting regulatory needs.
- To advocate for the inclusion of systematic reviews in research funding calls.
Main Methods:
- Systematic reviews synthesize existing evidence by collecting, analyzing, and critically appraising studies.
- This approach can generate new findings and summarize knowledge efficiently.
Main Results:
- Systematic reviews can inform clinical and policy recommendations, including regulatory decisions.
- They are effective in advancing scientific knowledge, comparable to primary research.
- Systematic reviews are crucial for identifying unknown adverse drug effects and knowledge gaps.
Conclusions:
- Systematic reviews offer pragmatic and rapid insights for regulatory bodies.
- Research funding calls should not pit primary research against systematic reviews but focus on the research question.
- Applicants should propose the most suitable research design, with assessors evaluating validity and relevance.
More Related Videos
08:36Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
17:28Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
Related Concept Videos
Drug Regulation
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drug Control Governance: Regulatory Bodies and Their Impact
Global Regulatory Systems
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...