Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data

 
• By Vibha Sharma

EU regulators explain how sponsors who are running integrated Phase I/Phase II trials can overcome default transparency settings in the Clinical Trials Information System to protect the disclosure of dosing details if these contain commercially confidential information.

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The Default Setting In CTIS Is To Make Trial Data/Documents Public At The First Opportunity • Source: Alamy

EU regulators have issued updated guidance explaining how sponsors of Category 2 trials under the Clinical Trials Regulation (CTR) can prevent the automatic public disclosure of dosing data in their study applications submitted via the Clinical Trials Information System (CTIS) in cases where such data are considered commercially confidential. 

Key Takeaways

  • EU regulators have come up with a workaround to protect the automatic disclosure of dosing data in integrated Phase I/II trials via the Clinical Trials Information System if such data are considered commercially confidential

The guideline, jointly developed by the European Commission, the European Medicines Agency and the EU Heads of Medicines Agencies, was updated with a new Q&A on 16 May that offers a workaround for sponsors of certain Category 2 trials who are struggling to protect commercially confidential dosing information

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