Why Are Clinical Research Contracts and Budgets So Complicated For Clinical Research Sites?

Summary

In this video, the speaker discusses the complexities of contracts and budgets in clinical trials, emphasizing the unique aspects of each study. They highlight the importance of overhead costs, such as administration and quality control, and how these can be negotiated with sponsors. The video also touches on the challenges of distinguishing between overhead, line items, and invoiceable costs, and the need for specialized knowledge to navigate these processes effectively. The speaker advocates for the use of networks like DSCS to streamline and democratize access to this information for sites of all sizes.

Takeaways

• 📝 Contracts and budgets are essential for clinical trial sites as they grow busier with more studies.
• 🤝 Special shout out to Chris, the business partner who handles contract and budget negotiations for Yuma Clinical Trials, a DSCS site.
• 🔍 The complexity of contracts and budgets comes from the uniqueness of each study and the various costs involved.
• 🏢 Overhead costs include administrative expenses, rent, payroll, and marketing efforts that benefit all studies.
• 🛡 Quality control and assurance systems are crucial for maintaining compliance with FDA regulations.
• 💻 Technology fees, such as eSource, can be part of the budget and may be passed on to sponsors.
• 📈 Recruitment costs, like those for advertising through platforms like Patient Ace, can be invoiced to sponsors.
• 🧊 Some costs like dry ice may be overhead, specific line items, or invoiceable pass-through costs depending on the study.
• 🍽 Patient meals and transportation are often invoiceable fees, but can also be considered overhead.
• 📈 Fair market value is important to understand for negotiating line items in contracts and budgets.
• 📚 Training costs for CRCs are part of doing business and can be negotiated into budgets for most studies.
• 🔄 Economies of scale and working with networks like DSCS can help streamline contract and budget negotiations.
• 🤖 Automation of certain aspects of contracts and budgets is possible, but the human element is still crucial for specialized knowledge and negotiations.

Q & A

What is the main topic discussed in the video script?

The main topic discussed in the video script is the complexities of contracts and budgets in clinical trials, particularly from the perspective of a clinical trial site.

Who is Chris Soer and what is his role in the context of the script?

Chris Soer is the business partner of the speaker and is responsible for negotiating all contracts for Yuma Clinical Trials, which is a DSCS site in the DSCS site network.

What does the term 'overhead' refer to in the context of clinical trials?

In the context of clinical trials, 'overhead' refers to the administrative costs such as rent, payroll, workers' compensation, branding, marketing, and community outreach, as well as quality control mechanisms and QA systems.

What is the significance of understanding the fair market value of procedures in clinical trials?

Understanding the fair market value of procedures is crucial because it helps in negotiating contracts and budgets accurately, ensuring that the site is adequately compensated for the services provided during a clinical trial.

How can a clinical trial site pass off certain costs to sponsors in a contract?

A clinical trial site can pass off certain costs to sponsors by including them as line items in the contract, such as eSource fees, technology fees, recruitment costs, and invoiceable pass-through costs like x-rays, MRIs, and local labs.

What is the role of Patient Ace in the context of the script?

Patient Ace is one of the speaker's other companies used for advertising on Instagram and Facebook. It is mentioned as a tool for recruitment in clinical trials, with the costs of the ads potentially being passed off to sponsors.

What is the difference between overhead costs and invoiceable costs in clinical trials?

Overhead costs are general operational expenses of the site that are not directly tied to a specific study, while invoiceable costs are specific expenses related to a study that can be billed directly to the sponsor.

Why is it important for a clinical trial site to have a quality management system?

A quality management system is important because it ensures that the site is following SOPs (Standard Operating Procedures) and is prepared for FDA audits, which are critical for maintaining compliance and credibility in clinical trials.

What is the role of a CRC (Clinical Research Coordinator) in a clinical trial site?

A CRC is responsible for coordinating the day-to-day activities of a clinical trial at a site. They ensure that the trial is conducted according to the protocol, and they may also be involved in training, which is an ongoing cost for the site.

What does the speaker mean by 'democratizing' contracts and budgets for clinical trial sites?

The speaker refers to making the process of contract and budget negotiations more accessible and understandable for smaller sites, possibly through the use of technology and support networks like DSCS, to level the playing field with larger sites and networks.

How can a smaller clinical trial site navigate the complexities of contracts and budgets without a network like DSCS?

A smaller site may need to learn the intricacies of contract and budget negotiations the hard way, possibly by hiring specialized knowledge like a contract negotiator or by gaining experience and understanding the industry standards and databases used by larger sites and CROs.