Decentralized Trials & Subcontracting: What Sites Need to Look Out For
Changes brought on by the pandemic have encouraged the industry to adapt quickly, especially when it comes to adoption of new technologies. Many sites pivoted to hybrid decentralized trials, meaning some patient visits were conducted virtually instead of on-site. However, some sites have still expressed hesitation with decentralized visits for various reasons. In the SCRS Member Community, sites discussed subcontracting concerns as one reason for declining decentralized trial opportunities.
One site shared, “We have been approached about participating in a decentralized trial. We think it may be good to get some experience in such a trial since there seems to be an interest by sponsors in moving in this direction.
Recruiting and many of the visits will be done remotely by another agency the sponsor contracts with. We have been asked to sign a delegation log listing the third-party company on the delegation log, not the specific personnel. We do not know the staff who will be working on their behalf. The staff may be in several different states. This makes us a little nervous as our PI is supposed to be responsible for the conduct of the trial and we really do not know the qualifications of any of the people working for this third party. Is this usual and customary?”
This language is not necessarily common, but some CROs may do it more than others. Sites, understandably, are apprehensive to agree to these terms. Many have declined studies because of this language alone.
To clarify, the CRO is responsible for the behavior of its vendors chosen – not the site. This should be stated in the CTA as an indemnification of the site. Additionally, CROs should allow sites the authority to change the vendor or people they work with at the vendor organization as needed. If the site agrees to this liability, they should have a say in who they work with. Additionally, sites should validate any vendors’ business insurance to limit their liability if they plan to sign a contract with this language.
SCRS Honorary President David Vulcano shared, “I have had conversations with FDA on this via an ACRP Fellows task force, and they don’t like it when the Sponsor/CRO picks the personnel and do not give the investigator any control. It’s fine for them to pay directly for the service, but unless the home visits are set up as a different site under a different PI (i.e. two site/PIs handing the subjects back and forth), you and your PI must be In control.”
If this language is included in your CTA, SCRS encourages sites to have a further conversation with the CRO. Liability should not be solely on the site, and at a minimum there needs to be indemnification language to ensure minimal liability for the site on behalf of the other organization. Sponsors and CROs can be proactive in contracts to provide sites with options for who they would like to work with and reduce the burden of liability for things the site cannot control. The best option, however, would be to separate the two organizations altogether in the CTA. The FDA may release guidance on this topic in the near future, but we recommend sites communicate their needs and concerns to improve industry partnerships for all.
