Analyzing the Publication Rights Clause in CTAs
- Author
- Darshan Kulkarni
- Published
- Mon 09 Sep 2024
- Episode Link
- None
Today's discussion revolves around the legal clauses found in clinical trials, with a focus on
Article 8, the Publication Rights Clause.
The following points are discussed:
- Unrestricted Rights: The clause prov
- ides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the integrity and proper use of the data.
- No Sponsor Review: There's no requirement for the Sponsor to review or approve publications, which can lead to issues with data accuracy, intellectual property rights, and compliance with regulatory standards.
- Intellectual Property Issues: The clause includes 'intellectual property' in the publication rights, which can lead to loss of proprietary information and patents for the Sponsor.
- Patient Data Exposure: Allowing publication of patient data without restrictions can breach confidentiality agreements and violate privacy laws.
