One of the most important things in developing a clinical trial agreement remains the language found within the contract. Even the smallest mistake can open the door to a huge amount of risk to a site or a sponsor. This session provides an in-depth look at the framework for these contracts.
- Explore the language regularly seen within the contracts
- Avoid limiting terms within the agreement
- Differentiate the preferred terminology between sites and sponsors
Budget may be one of the first things discussed during clinical trial negotiations. Agreements must specify budgetary guidelines within the total amount allotted to the trial, as well as how this money will be dispersed.
- Ensure the budget for the testing falls with Fair Market Value (FMV)
- Set the terms for the release of funding to the site
- Amend the contract for an expanded budget and why this may be needed
- Understand the relation of a trial’s budget to the review of case report forms
COVID-19 still remains the focus on all clinical trial professionals. With the approval of a couple of vaccines (and more to come) and hospital staff being first to be vaccinated, hope of the impact of COVID-19 being reduced to happen soon is on the horizon. But prior to COVID-19 no longer being an issue on clinical studies, what considerations were given to the contracts?
Look at the impact of the guidance issued by the FDA in relation to COVID-19
Evaluate how the terms of an agreement and study procedures have changed to allow for impact of COVID-19 on clinical studies
Confront how has the COVID-19 pandemic has changed clinical trial agreements
When one clinical trial concludes, another begins. There can be occasions in which biospecimens remain from a previous trial that are a fit for the next. Prior to their use, sponsors must include the proper language in multiple agreements with participants to avoid any type of fiscal penalties. This session explores what must be agreed upon prior to additional uses of these biospecimens.
- Review HIPAA privacy rules surrounding biospecimens
- Fold biospecimen rights into informed consent documentation
- Center the confidentiality of identifiable protected health information
Secrecy remains the top priority of pharmaceutical and biologics manufacturers when contracting with sites. Incorporating clauses within clinical trial agreements to protect a sponsor’s right remains crucial to control shared information.
- Assess the site’s participation in drafting the protocol in the clinical trial agreement
- Scrutinize U.S. patent law to ensure the sponsor retains ownership of the IP
- Prepare for the full gamut of associated time limits and costs
With clinical trial agreements holding stringent confidentially terms between sites and sponsors, it is important to understand the rights of each. You can improve confidence on trial results by making certain the contract features firm clauses protecting a sponsor’s IP.
- Incorporate confidential disclosure agreements into the overall agreements
- Distinguish between Investigator Initiated Trial vs. Sponsor-Authored Trial
- Define terms surrounding electronic medical records
- Emphasize a site’s right to publish findings
Negotiating directly with a sponsor is quite different from having a CRO negotiate on the sponsor’s behalf. While they are third-party organizations, their representation of the sponsor can have a large effect on all other parties involved.
- Incorporate terminology to protect the trade secrets of the sponsor into the contract
- Understand the sponsor’s definition of “poor performance” by the CRO, and the effect this holds on the contract
- Determine protections are offered to the sponsor when they are represented by a CRO
Nothing is a bigger risk in the clinical trial space than subject injury. Should participant face any sort of harm, both the site and sponsor can be held responsible. Ensuring that the proper protections are placed in the contract are what protects you from potentially facing huge financial penalties.
- Prepare the necessary informed consent documentation
- Outline the institution’s role to offer an acceptable standard of care
- Incorporate clauses for compensation within the contract
Currently, no type of testing is being used more than telemedicine. While COVID-19 has slowed a lot of research, technology allows these essential tests to continue. However, regulations have changed surround clinical trials in this form and it is crucial that your agreements meet the regulations which have been put into place.
- Analyze the state regulations surrounding virtual Clinical Trial Agreements
- Alter a CTA to transition to telemedicine
- Evaluate the use of virtual clinical trials during the COVID-19 outbreak
- Guide sites to conduct the proper testing virtually