We are excited to announce that TIMESPAN has been officially registered as a network in the Catalogue of Real-World Data (RWD). But why does this matter? Let me explain why we think this is an important step toward improved methodological standards and governance principles for pharmacoepidemiology studies on ADHD.
It has been increasingly recognized that pharmacoepidemiology studies of ADHD medication represent an important complement to Randomized Clinical Trials (RCTs). By leveraging RWD sources from large-scale health registers, electronic health record databases, and other sources of observational data, pharmacoepidemiology studies can provide insights into the real-world effectiveness of ADHD medication across a broader spectrum of patients, outcomes, settings, and timeframes than those typically included in RCTs.
One frequently discussed concern in pharmacoepidemiology research is methodological transparency and selective reporting. A significant challenge is that non-significant studies are often not published, which can contribute to publication bias. Even when studies are published, there is a tendency to selectively report findings, emphasizing statistically significant or favored results while downplaying or omitting non-significant outcomes. Selective reporting is a widespread issue in the research process, not just in pharmacoepidemiology, undermining the integrity and reliability of findings.
To address this, leading authorities like the European Medicines Agency (EMA), the International Society for Pharmacoepidemiology (ISPE), and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) strongly recommend preregistering the protocols for pharmacoepidemiology studies. The preregistration includes key details such as the study’s rationale, research questions, inclusion and exclusion criteria, primary outcome measures, and statistical analysis plan. This practice is critical to enhancing transparency, reducing bias, and strengthening the evidence drawn from RWD.
As part of the EMA and Heads of Medicines Agencies (HMA) Big Data Initiative, the Catalogue of RWD Sources and the Catalogue of RWD Studies were launched in 2024. These catalogues aim to help regulators, researchers, and pharmaceutical companies identify relevant real-world data sources, studies, and networks, all while adhering to FAIR principles—making data Findable, Accessible, Interoperable, and Reusable.
We are proud to announce that we have now registered TIMESPAN as a network in the Catalogue of RWD. – see https://catalogues.ema.europa.eu/network/1000000449
Registering TIMESPAN in the Catalogue of RWD is important as it helps facilitate the conduct of high-quality, multi-centre pharmacoepidemiology studies in Europe and beyond. We hope that our registration will help foster further collaboration and contribute to improved methodological standards and governance principles for pharmacoepidemiology research. Our registration underscores our commitment to transparency, rigorous research practices, and ultimately improving healthcare outcomes through high-quality pharmacoepidemiology studies.
This post was written by TIMESPAN coordinator Prof Dr Henrik Larsson.