Association between clinical trial activity and post-marketing access to new cancer medicines : Evidence from Finland and other Nordic countries
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Clinical trials are essential for developing new medicines, generating evidence on safety and efficacy while also providing early access to therapies and strengthening clinical expertise. Despite this, clinical trial activity, including in oncology, has declined in Europe and the Nordic countries. At the same time, the number of approved cancer medicines has increased, yet access varies across countries and challenges persist even in high-income settings. However, empirical evidence on the relationship between clinical trial activity and post-marketing access to cancer medicines remains limited. This study aimed to describe trends in phase III oncology clinical trial activity, access to newly approved cancer medicines across the Nordic countries, and to explore the association between the clinical trial activity and the post-marketing access to new cancer medicines.
A 10-year retrospective observational study (2015–2024) was conducted using publicly available EU and Nordic data, complemented with commercial IQVIA first sales data. Clinical trial activity was measured both as the annual number of phase III oncology clinical trials and at the drug-level across countries. New cancer medicines were defined as those approved in EU from 2015 onwards. Post-marketing access milestones were measured using regulatory and administrative data to capture market entry, reimbursement/recommendation, and first sales depending on data availability in different
countries. Time to access was defined as the delay between regulatory approval and each access dimension.
Clinical trial activity showed broadly similar trends across the Nordic countries. However, variation existed in both the volume and distribution of phase III trials for new cancer medicines, with the highest levels in Denmark and Sweden, the lowest in Iceland, and moderate levels in Finland and Norway. Access and time to access of new cancer medicines also varied between countries but differences were generally modest. At the drug level, medicines with more clinical trials were more likely to be available across countries, whereas no clear association was observed between total clinical trial activity and post-marketing access at the country level.
In conclusion, higher drug-level clinical trial activity was associated with greater post-marketing access to cancer medicines, although this finding should be interpreted with caution. Differences in access definitions and data availability highlight challenges in comparing access across countries and achieving real patient-level access. Overall, access is multidimensional and influenced by structural, regulatory, and economic factors beyond the possible role of clinical trial activity.