START Clauses
"These standardized contract clauses enable contract negotiators to ?begin at the end rather than the beginning."
Dr. James Doroshow
NCI Division of Cancer Treatment and Diagnosis
The Problem
Contract negotiations between clinical trials sponsors (pharmaceutical, biotech, or medical device companies), academic medical centers, and principal investigators often add months to the process of starting a clinical trial. These delays can add as much as $1 million per day to the overall cost of conducting a trial. To help speed up the initiation of clinical trials and eliminate excessive or repetitive costs, the CTWG recommended establishing commonly accepted language for clinical trial contracts (Standardization Initiative 4).
The Solution
To fulfill this recommendation, NCI and the Life Sciences Consortium of the CEO Roundtable on Cancer have jointly developed a set of common clauses, or START (Standard Terms of Agreement for Research Trial) Clauses, that are accessible for any party to use when initiating a trial. These standard clauses provide common language for use as a starting point in the contract agreements that govern clinical trials.
The clauses are based on a confidential, third-party expert analysis of redacted copies of 80 final negotiated clinical trial agreements provided by 14 representative NCI-designated Cancer Centers and the 11 pharmaceutical companies of the Life Sciences Consortium of the CEO Roundtable on Cancer. This analysis revealed that several key concepts showed greater than 67% similarity across the agreements, demonstrating that negotiations frequently reach common endpoints for those concepts.
The Results
The START clauses contain model language on these key concept areas:
- Intellectual property
- Study data
- Indemnification
- Subject injury
- Confidentiality
- Publication rights
When put into action, NCI and the CEO Roundtable anticipate that the START clauses could reduce contract negotiation time from as many as 300 days to as few as 30 days.
The clauses are provided here for informational purposes only. Their use is voluntary, and they are designed to serve as a starting point for contract negotiations.
Download the START clauses and begin using them now!
We encourage you to share them within your organization, with your legal and regulatory affairs staff, and with organizations that you will be negotiating with.
For more information, contact the Coordinating Center for Clinical Trials.
