The Life Sciences Consortium forged a partnership with the National Cancer Institute (NCI) to develop common clinical trial contract standards with the research-intensive pharmaceutical and biotechnology industry. Called the S.T.A.R.T. Clauses, these standards are freely available for use to hasten the initiation of cancer clinical trials and thus, the discovery and delivery of novel and improved therapies for cancer patients.
The S.T.A.R.T. 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 S.T.A.R.T. Clauses can simplify and accelerate the contracting process. Although developed with cancer clinical trials in mind, the S.T.A.R.T. Clauses are applicable to all types of clinical research.
The S.T.A.R.T. Clauses focus on two types of agreements:
- Company-sponsored clinical trial agreements
- Investigator-initiated clinical trial agreements
The S.T.A.R.T. Clauses contain model language in six key areas:
- Intellectual property
- Study data
- Indemnification
- Subject injury
- Confidentiality
- Publication rights
For more information, download the S.T.A.R.T. Clauses brochure, or visit the NCI’s Coordinating Center for Clinical Trials website.