Contract & Budget Negotiation
A legally binding and fully executed Clinical Trial Agreement (CTA) is required by Stanford before a Principal Investigator may conduct a clinical trial when the study drug or device, financial support and/or proprietary information is provided by a for-profit sponsor.
The CTRMG team has been delegated authority and responsibility to review, negotiate and execute CTAs on behalf of Stanford. Through a negotiation process, the CTA upholds Stanford’s policies and regulations while also allowing Stanford investigators to provide data and/or results, contribute to publications and improve clinical care options for patients. The CTA allocates risk, responsibility, funds, and obligations while also protecting the interests of both the academic institution and the sponsor.
CTA includes an agreed upon budget for the sponsor to provide funding to cover the costs to conduct the clinical trial. While sponsors seek to keep costs as low as possible, costs to conduct a clinical trial are hard to predict and variable from site to site, so negotiation is necessary to minimize any financial risk for Stanford.
How to work with CTRMG team during negotiation process
CTRMG team gathers information from study team and sponsor to facilitate discussion and reach an agreement. Key information helps to make informed decisions and for us to work together and efficiently execute the best possible deal for study team with a sponsor:
Best possible agreement with a sponsor will:
- protect Stanford’s interests and ensure institutional policies followed
- secure adequate funding and minimal financial risk to conduct the study
- leverage study team’s strengths
- strengthen relationship with sponsor
5 steps to the Negotiation Process
For each step your CTRMG partners may request specific feedback to inform and/or guide the process:
1. Preparation and Planning – Study KO Meeting Discussion
-Information leads to informed decisions
-Gather information from study team and sponsor to effectively and efficiently negotiate
-Important to ask the right question upfront before going into negotiations
- Action plan in advance to an unfavorable counter-offer
2. Definition of Ground Rules/Agreement on Assumptions
- Terms of the CTA must support site’s responsibility to conduct high-quality research
- Collaborative approach to find a win-win solution with sponsor whenever possible
- Appreciate that as a clinical trial site, we have different needs and wants than the sponsor
- Cannot assume we know what are the sponsor needs and wants
3. Clarification and Justification
- Stanford policy is the foundation of our negotiation process and limits our flexibility
- Per patient budgets are fixed cost and reflect our best estimate of the anticipated costs.
4. Bargaining and Problem solving
- Understand sponsor’s position and look for options to bridge the gap, solve the problem or resolve the issue
- Identify fair and assertive goals
5. Closure and Implementation