CCCT implements programs in response to recommendations from NCI advisory boards and strategic working groups to enhance NCI's clinical trials and translational research enterprises.
Standardized Case Report Forms (CRFs)
Clinical trials using consistent Common Data Elements and standard Case Report Forms modules improve study start-up times and facilitate data collection. A core library of CRFs and data collection modules have been developed through stakeholder consensus.
START (Standard Terms of Agreement for Research Trial) Clauses
The START clauses represent a toolkit that provides standardized legal language for key agreement elements common to most clinical trial agreements. By starting the negotiation process with commonly agreed upon language, the START clauses can simplify and accelerate the contracting process. Although developed with cancer clinical trials in mind, the START clauses are applicable to all types of clinical research.
The clauses were developed through a project jointly sponsored by the CEO Roundtable on Cancer and the National Cancer Institute 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.