News

Clinical Trials Budgeting – Getting our Costs

By Bobby Gatson

The budget specialists in the Clinical Trials Office negotiate budgets with industry sponsors and ensure all anticipated and actual costs of the trial are covered. The budget specialists in the CTO function as an extension of your team. Our goal is to provide you with a finalized budget that meets your needs for completion of the industry clinical trial.

Clinical procedures and laboratory tests are coded costs, which are submitted in our budgets at the Medicare rates. Sponsors can easily search databases and determine that the costs we have input in our budgets for these items are correct and fair market value. While issues come up in negotiations regarding these costs, sponsors usually pay them given that these costs are unavoidable if we are to conduct the study.

Less clearly defined are the labor costs of doing a trial. Nascent labor expenses in doing clinical trials occur, and we can get compensated for them. Arm your budget specialist for TROJAN battle by identifying and justifying those costs. This will ensure that budget negotiations are timely and successful.

It is important to remember that the person(s) working on behalf of the sponsor with the budget are generally not clinical staff and may require detailed information for cost justification. They are often given cost parameters to operate within. If our costs exceed those parameters, we need to provide cogent information that justifies the increased cost.

Here are a couple of things you can do to help facilitate the labor portions of budget negotiations:

• CRFs. If you have the CRFs, provide them to the CTO along with any information that may assist us in budget negotiations regarding labor costs. Frequent issues come up with the timeframe required to complete the CRFs. Discussions can occur with your budget specialist prior to submitting budgets to the sponsor regarding CRF completion.
  • Example: Sponsor’s CRF has 3 questions that need to be answered for one section of the CRFs. We have budgeted that it will take 30 minutes to complete this section of the CRF. The sponsor contact’s response to the budget specialist will usually be, “It doesn’t take 30 minutes to input the answers to these three questions.” The Coordinator, prior to submission of the budget, has explained that each of these three question requires gathering information from source documentation. Calculations are then completed with that information, which allows each question to be answered. Thirty minutes to complete this 3 questions, is much more justifiable when the USC budget specialist has this information to provide to the sponsor contact in their discussions.
• Hidden costs. The budget specialist will advocate for payment for items that are not readily identifiable in a spreadsheet. Be sure to capture this and any other costs you would not be completing except to facilitate tasks required by the study protocol.
  • Example: Transporting patients from one area to another for protocol required testing. When study participants are required to be in other locations of the building or the campus and you are physically escorting or assisting them to get there, your time for this task should be compensated. You would not be performing this task except for completing work required for the study. Be sure to capture this and any other costs you would not be completing except to facilitate completion of the study protocol requirements.

Please feel free to contact one of our budget specialists if you have industry budget-related questions. They will be glad to will assist you or get you to the appropriate person who can assist you.

Denise Deack (323) 442-7395
Teresa Trejo (323) 442-7396
Bobby Gatson (323) 442-7394

DocuSign Electronic Signatures Now Accepted by DCG and CTO

By Sara Katrdzhyan

To improve processing and study start-up timelines for all research contracting, the DCG and CTO have adopted DocuSign as our electronic signature system. DocuSign is a market leader in e-signature systems. After surveying our sponsors and academic partners, many are using or accept DocuSign as an alternative to their traditional execution process. The expected benefits are:

• Improving the speed of study start-up
• Creating improved visibility into document execution status
• Freeing-up resources within CTO and DCG department staff and sponsors by automating a previously paper-based process
• DocuSign is considered to have the highest security, legal enforceability and compliance standards of available signature systems
• Accessible on mobile devices for review and signing of documents

If you have any questions, please contact your DCG Contract Officer or CTO Contract Manager.

Research Order Forms – A Promissory Note to Pay….What Does this Mean?

By Cynthia Morales and Nora Turrey

When completed, the Research Order Form (ROF) serves as a clinical order and defines which services are billable and payable by the research study (i.e. the Sponsor). Providers will access the ROF in the medical record and bill all charges indicated on the ROF to research. Billing the Sponsor is a function managed by the CTO Post-Award team.

Tests and procedures included in the sponsor’s protocol do not automatically make routine patient care costs billable to the study sponsor; Medicare Coverage Analysis and negotiations with the study sponsor determine such billing arrangements.

Always refer to the Medicare Coverage Analysis document along with the ROF to confirm budget and billing requirements. These documents can be found within TRUE (www.uscnorris.com/CRO) for studies submitted to the CTO prior to April 1, 2016. For Studies submitted to the CTO after April 1, 2016, please refer to OnCore to review the ROF and MCA.

Always check True/OnCore to ensure that the most current ROF is utilized to help avoid potential billing discrepancies.

If the study team inappropriately completes the research order form and the provider is unable to bill insurance, the research study account will be charged for services provided to their participant.

Intellectual Property Terms in Research Agreements

By Melissa Archer

Negotiating a clinical trial agreement can seem like a daunting task, but the Clinical Trials Office has a dedicated team to represent and usher you through the process. Our goal is to ensure that faculty at USC has access to cutting edge therapeutics and external financial support to conduct innovative research that will both improve the lives of our patients while strengthening our reputation as a research institute. But we need to balance the importance of our policies with the commercial interests of our industry partners.

It is the industry standard amongst academic centers that all inventions made by its employees or contractors are owned by the institution/academic center. This position ensures a certain amount of control in how important new healthcare improvements are introduced to the market. However, when research includes intellectual contributions from our collaborators, we have a process in place to consider these contributions in our handling of IP ownership. 

Types of agreements negotiated by CTO
Confidential Disclosure Agreement (CDA): Established before the exchange of proprietary information. These agreements ensure that parties maintain ownership of valuable and proprietary protocols, ideas, data sets, inventions, etc.

Clinical Trial Agreement – Investigator Initiated Trial (IIT) vs. Sponsor-Authored Trial: These agreements cover obligations for conducting research involving human subjects. With IITs, it is standard in the non-profit research community that academic institutions maintain ownership to inventions where investigators have authored the protocol. On the other hand, Sponsor-Authored Trials are solely designed by the commercial partner and USC is simply carrying out the protocol without creative input. For this class of studies, sponsors file broad patents for the anticipated use of a drug or device and new inventions are unlikely. If this is the case, USC may consider a policy exception and allow commercial sponsors to own inventions that result from performing their protocol.

IP Positions within Agreements: U.S. patent law defines ownership as following inventorship, meaning he/she who conceives of a new invention is also the owner. In many ways, USC’s policy follows this idea, protecting inventions that our faculty and staff contribute to, whether alone or with others. Although commercial partners have their own set of for-profit obligations when providing proprietary information/products and/or funding and would prefer a quid pro quo exchange of their support for ownership to new IP, inventions are made available to our biotech, pharmaceutical and medical device partners via reasonable royalty bearing licensing options. This ensures USC may reinvest revenues into our research mission while working with industry partners best suited to bring new IP to market.

The Negotiating Process
The CTO and USC Stevens work together to customize IP terms that suit the needs of each study and the negotiation process can include multiple draft exchanges with our sponsor’s legal team. Although most IP negotiations are successful, we will encounter challenges. We do not want to stifle our faculty’s ability to participate in research, which in turn may limit access to innovative care for our patients and scientific benefit to the general public, so if IP terms are in conflict with institutional policy, we will engage principal investigators to assist with sponsor discussions. We then, collectively with USC Stevens, conduct a risk analysis, allowing all potential stakeholders to make an informed decision as to risks and potential benefits of working outside of established policy. CTO and USC Stevens are here to assist in this analysis and preserve your rights to current and future research endeavors.