Clinical trials on medicinal products

Number of applications received for clinical trials on medicinal products

The Swedish Medical Products Agency regularly presents statistics for the number of applications received (data from the journal “Information från Läkemedelsverket”, number 4 2015 and “Årsstatistik 2022 - kliniska läkemedelsprövningar”). When comparing EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) and the Swedish Medical Product Agency’s case management system, the number of applications received differ slightly, but over time both sources show similar trends.

The differences are caused primarily by the Swedish Medical Product Agency’s case management system including resubmissions, and that VHP applications (voluntary harmonisation procedure, a process for joint EU evaluation of applications) are registered at different times with the national medical product agencies compared to the original registration in EudraCT.

Applications divided up into commercial and academic clinical trials on medicinal products

The Swedish Medical Products Agency’s annual statistics show information on how the number of applications is divided up between academic and commercial clinical trials on medicinal products*. The number of clinical trials on medicinal products has been relatively stable during the last 10-year period, for both academic and commercial sponsors. A small reduction is noted for commercial trials during 2019–2020, followed by a recovery in 2021–2022. The proportion of commercial clinical trials on medicinal products is around 70% (average for 2020–2022).

* The concepts of “industry-sponsored” or “company-sponsored” are often used synonymously with “commercial” clinical trials on medicinal products. The concept of “non-commercial” is used correspondingly for “academic” clinical trials on medicinal products. The concepts are based on the regulatory division of the responsible sponsor of applications to the Swedish Medical Products Agency.

Clinical trials on medicinal products divided up per study phase

Annual statistics from the Swedish Medical Products Agency include information on how applications for clinical trials on medicinal products are divided up into different study phases (Phase I-IV)*. The distribution is 13% for Phase I, 31% for Phase II, 45% for Phase III and 11% for Phase IV (average for 2020–2022; studies lacking phase data have been excluded).

* Description of the different study phases in a clinical trial on medicinal products. Phase I focuses on safety and dosage, Phase II evaluates efficacy and safety on a larger scale, Phase III confirms the result in an even larger and more varied population ahead of agency approval, and Phase IV relates to after-market monitoring of the medicinal product’s effects when used by broader population groups.

Number of applications approved for clinical trials on medicinal products

An excerpt from the Swedish Medical Product Agency’s register (June 2023) shows that a large proportion of all applications are approved. In 2020–2022, 94 per cent of the applications were approved on average. The number of rejections was 1 per cent during the same period. This figure has been between 1 and 2 per cent in previous years as well (data from the Swedish Medical Products Agency’s journal “Information från Läkemedelsverket”, number 4, 2015). The number of applications received can therefore be assumed to be representative of the number of approved applications over time.

The years are the year the case in question was received by the Swedish Medical Products Agency, even if the decision is sometimes made the following year. Decisions designated as “other” usually mean that the application was recalled or ran out of time, or that a decision has not yet been taken (for 2022, three cases were waiting for a decision in June 2023).