Her er litt byråkratisk info om det som sannsynligvis er relatert til innledende forsinkelse vi hadde i EU-SolidAct litt tilbake i tid (men jeg husker det bare svakt, så mulig jeg kobler det feil), publisert på Pink Sheet i dag. Kanskje noen finner det interessant:
Straightforward But Technical: Transferring Existing Studies To EU Clinical Trial Portal: https://pink.pharmaintelligence.informa.com/PS146769/Straightforward-But-Technical-Transferring-Existing-Studies-To-EU-Clinical-Trial-Portal
Krever en trial for å få tilgang, så her er PDF av saken:
Straightforward But Technical_ Transferring Existing Studies To EU Clinical Trial Portal __ Pink Sheet.pdf (1,3 MB)
Her er sitat av avsnittene jeg fant relevant til EU-SolidAct:
The trial “needed three attempts to transition” so “maybe [it was] not the perfect pilot,” he noted. The transition request was for EU-SolidAct, a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The trial was submitted to the CTIS on 15 March and was authorized by the 14 member states concerned (MSCs) at different dates, with Austria authorizing it on 25 May.
A key factor that contributed to the long transition timeline for EU-SolidAct was the fact that its sponsor, Oslo University Hospital, had not completely harmonized the trial under the CTD “and this is definitely what you should do” before submitting a transition request, Strasser explained. “It’s in the best practice to do that,” he added.
The transitioning of the EU-SolidAct trial was also a learning experience for Austria. The country’s regulators want all authorized documents uploaded [into the CTIS] at the time of transition. Strasser noted that this may be contradictory to what was being advised in the European Commission’s CTR Q&A guideline, but “now that we see how it really looks and feels,” this advice may be changed.