As the pipeline of clinical trial work evolves and changes over time, the importance of quality relationships between sites and sponsors and CROs will increase. Sponsors and CROs will engage sites that align with current and mid-term projected opportunities and remaining in contact over the long-term will become even more important. Attendees gained insight into navigating clinical trial evolution to position their sites for success. Chris Hoyle of Elite Research Network facilitated the session with panelists Silvina Baudino of Teckro, Lindsey Morales of Labcorp Drug Development, Robyn Schmidtke of Merck.
Fundamentally, this session focused on communication. As we know, partnerships of any type are all about communicating with and learning about one another. But, what does it mean to communicate? What does it mean to be honest and build trust with one another?
Sites, speak up! Sponsors and CROs want sites to share information and challenges because “if they don’t know about it, they can’t help you with it.” Keep conversations going about training as the industry looks for solutions to minimize the amount of training needed for new technologies and reduce overall technology burden for sites. Be open and candid and transparent about the things we’re learning with each other.
One popular point of discussion sites shared was that CRO databases seem to be places where information just goes into a black hole. Industry is incorporating site feedback and working on better databases to keep everything in one place and reduce redundancies, so please continue providing feedback.
We also shared how crucial it is for our industry to attend meetings and conferences to take communication to a new level by putting a face to a name and building a personal connection. Industry conferences, virtual meetings, site advocacy or focus groups, and community forums are a great place to foster relationships and provide value to one another throughout the year. Continue reaching out to sponsors and CROs to find people you can partner with and who will be an advocate for your site. They want to know you and help you as much as they can, so don’t be afraid to ask for assistance or contacts if needed.
It’s no secret that digital innovations are here to stay, especially in the form of decentralized trials. While there are important considerations to be made from an administrative and process perspective, it is equally critical that we consider how patients will be affected. This session discussed how decentralized trials affect patient interaction so we can ensure patients’ needs are addressed.
Facilitated by Todd Albin of Cedar Health Research, panelists included Deena Bernstein of Datacubed Health, Nicole Latimer of Medrio, Scott Connor of Signant Health, and Karin Gulbrandsen of Janssen.
Understandably, sites remain concerned about building and maintaining patient relationships when using DCTs. However, the intent of decentralized clinical trials (DCTs) is to engage patients where they are and increase retention. Many opportunities remain to build relationships with trial subjects in different ways and may be nourished through a combination of phone calls, video calls, texts, and in-person visits.
Sites are also apprehensive about PI oversight specific to DCTs due to lack of understanding of regulations. PIs still need to make sure they are delivering quality expected from in-person visits, while industry needs to provide guidance for investigators as they navigate these new expectations.
It was also shared that sponsors and CROs need better understanding of financial liabilities for sites regarding implementation of new technology. Sites expressed that budgets are often poor with DCTs, yet add a lot of work for the site. Additionally, many digital platforms ask for specs, then other sponsors or studies ask the same information again. Communicating these challenges can help industry to create a uniform way for sites to provide technical authentication pieces in the future. It’s important to remember that adding new technologies to trials is not one-and-done; as we implement different elements, we need to continue to get the feedback on what’s working and what’s not. It’s an ongoing learning process that will only be successful if sites and industry work together to find solutions that benefit all.
FDA audits are an inevitable reality that all sites should be prepared for before they are audited. This session included perspectives from those who have experienced FDA inspections to share how they prepared for the audit and what measures they have implemented to ensure future inspection-readiness.
Ana Marquez of Clinical Research Partners facilitated the session with panelists Shivani Shah of DM Clinical Research, David Vulcano of HCA Healthcare, Rick Arlow of Complion, and Lisa Kodis of Illingsworth Research Group.
This session discussed recent FDA audit need changes and what the FDA is looking for, such as informed consent issues and delegation log issues. How do sites prepare for audits? Panelists noted that it is critical to prepare site staff by discussing specific steps to take after being notified of an audit. Sites should identify a key team for inspection and minimize involvement of too many people as much as possible. One option may be to hire an expert to assist you with the process, especially if you have been issued a 483. Investing in the proper individual to guide you through it can make it a much easier process for your site.
It’s also important to note that sites can set limits in their contracts when it comes to FDA inspections regarding communications protocols, such as only notifying the sponsors whose trials will be affected by an audit.
SCRS will continue to host workshops, webinars, and provide resources for sites to self-monitor and be as prepared as possible for FDA inspection. FDA also offers an audit manual online that industry can pull which shares every question to anticipate the auditor asking.
The meeting then separated into breakout sessions to discuss takeaways from these sessions and the 2021 Global Site Solutions Summit. We hope you will join us for the next Site Solutions Summit and encourage you to get your tickets as early as possible to secure the lowest rate! For the full November 2021 Sites NOW discussion, watch the Sites NOW meeting recording here.