Recent News & Communications
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William G. Nelson, M.D., Ph.D., a member of The Johns Hopkins University School of Medicine faculty since 1992,
has been selected to lead the Sidney Kimmel
Comprehensive Cancer Center at Johns Hopkins.
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Standardized/Harmonized Clauses for Clinical Trial Agreements
The National Cancer Institute (NCI) and the CEO Roundtable on Cancer jointly sponsored an effort to develop common language
for use in the contract agreements that govern clinical trials. The clauses were developed because negotiation of clinical trial
agreements between industry and academic medical centers is viewed as one of the key barriers to timely initiation of clinical trials.
The clauses are based on a confidential, third party expert analysis of approximately 50 redacted copies of final negotiated
clinical trial agreements provided by 14 representative NCI-designated Cancer Centers and the 11 pharmaceutical companies of
the CEO Roundtable Life Sciences Consortium. The analysis revealed that key concepts with regard to intellectual property,
subject injury, indemnification, data, confidentiality, and publication rights showed greater than 67% convergence across the
agreements demonstrating that negotiations frequently reach a common endpoint for those concepts. The proposed clauses provide
model language embodying those key concepts.
The Proposed Standardized/Harmonized Clauses for Clinical Trial Agreements are provided for informational purposes only.
Their use is voluntary and they are designed to serve as a starting point for contract negotiations. For more information,
please contact the Coordinating Center for Clinical Trials at nciccct@mail.nih.gov.
Two versions of the document are available here:
Agreement (.pdf format)
Agreement (.doc format)
They are also posted on our Download page.
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September 2008 Interim CCSG Guidelines
Here is a new and interim version of the Cancer Center Support Grant Guidelines.
This new version, which contains no significant changes, will take effect with the January 2009 application date; it should have
no impact on applications already in process for 2009 receipt dates. Among the modifications are: incorporation of guidelines
clarifications issued since the last version and previously found on our website, updated application dates and list of required
federal citations, and standardization of text on clinical trials with that found in National Cooperative Group and SPORE Guidelines.
We also have added a more detailed table of contents and increased margins and spacing for better document readability.
A summary of modifications and relevant page numbers is also posted for your convenience in review.
Both documents can be found on the Download page
and the Grants & Funding page.
Please feel free to contact our office if you have questions or concerns.
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