National Cancer Institute
National Cancer Institute U.S. National Institutes of Health

START Clauses – Frequently Asked Questions

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What is the biggest barrier to the timely initiation of cancer clinical trials?

Negotiation of clinical trial agreements between industry and academic medical centers is one of the key barriers to timely initiation of cancer clinical trials. This is because clinical trial agreements typically involve a trial sponsor (a pharmaceutical, biotech, or medical device company), a research institution, and a principal investigator. Separate agreements are negotiated in their entirety for each clinical trial.

Due to the lengthy, complex negotiation process, it can take as many as 300 days to negotiate the agreement, which can delay the start of the trial and delay availability of new cancer treatments to patients in need.

How can the negotiation process become more efficient?

Access to standardized legal language for key elements of clinical trial agreements can increase the efficiency of contract negotiations, resulting in reduced costs and accelerating the entry of new therapies into clinical trials. These are called standardized clauses.

What are the START clauses?

Representatives from the Life Sciences Consortium of the CEO Roundtable on Cancer, a non-profit organization composed of corporate executives from major American companies representing diverse industries, and several NCI-designated Cancer Centers have developed a set of standardized clauses for use in clinical trial agreements. These are referred to as the Standard Terms of Agreement for Research Trial (START) clauses.

How can the START clauses expedite clinical trial negotiations?

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 START clauses focus on two types of agreements:

  • Company-sponsored clinical trial agreements
  • Investigator-initiated clinical trial agreements

The START clauses contain model language in six key areas:

  • Intellectual property
  • Study data
  • Indemnification
  • Subject injury
  • Confidentiality
  • Publication rights

How were the START clauses developed?

The START clauses were developed following review of nearly 80 redacted copies of final negotiated clinical trial agreements from participating organizations, including company-sponsored and investigator-initiated trials. Independent third-party experts analyzed the agreements to identify areas where the language tended to be very similar across agreements. This analysis revealed that several key concepts showed greater than 67% similarity across the agreements, demonstrating that negotiations frequently reach a common endpoint for those concepts. Based on this analysis, standardized language was developed for the six common clauses for both company-sponsored and investigator-initiated agreements. The START clauses were shared with representatives from the participating organizations and are now being incorporated into their clinical trials agreements.

How can I access the START clauses?

The START clauses can be downloaded in both PDF and MS Word format from the Toolkit on the right-hand side of the START Clauses main page.

For more information, or assistance, on the START clauses, please contact the Coordinating Center for Clinical Trials.