Throughout the course of a study, numerous issues can occur at the site level when managing clinical supplies. If you’re a principal investigator, you may encounter storage concerns (e.g. “large patient kits including many bottles or blister cards need space to store; cold chain storage space at clinical site”). Patients on the other hand, may have difficulty adhering to accurate dosing instructions when taking the investigational products home. There are a multitude of issues that if unaccounted for could have far-reaching implications on a study. Below is a checklist of things to consider that will enhance relationships between all stakeholders involved.
How to Enhance Relationships
1. Pharmacy Services
The onus should be on the sponsor to train employees on site on how to conduct the trial, additionally providing guidance on the design for packaging and labelling of the supplies. As the trial is being conducted, be sure to offer pharmacy expertise in the development and administration of investigational products. Sponsors should have on hand expertise in pharmacy operations on clinical sites. Experts should also facilitate in providing solutions to site-specific concerns, such as the administration of injectable drugs and admixing.
2. Temperature Excursions
Sponsors should have an educated site staff (or individuals) that can respond to the warehouse as well as deal with temperature excursions, such as IRT guidance as well as product replacement. Furthermore, they must store responses and data in one location, and importantly, there should be a single point of call for the team to send excursion requests via an IRT help desk.
3. IRT (Interactive Response Technology) Help Desk
In establishing an automated IRT help desk, it helps to provide frequently asked questions for IRT-related questions. Additionally, it’s always helpful to have in place a “back up” contact, who can respond to questions that can’t be answered.
4. Direct Communication to Sites or Patients
Set up a general email inbox that covers common site enquiries. Ensure all stakeholders are accessible and available online through instant messaging. This is essential especially when considering the use of phone hotlines are on wane and the technology around us is rapidly improving. Going forward, don’t underestimate the reach of websites and patient portals as it could be of use to site staff, sites and patients.
Vendor Relationships – How can they help?
When it comes to improving vendor relationships, it’s important to clarify all the services the sponsor needs. Furthermore, plan upfront to avoid setbacks at the therapy stage on the back end. Ensure the vendor is has a strong sense of the sponsor’s company culture and is clear on what’s expected of them throughout the course of the trial. It’s also important to ensure the vendor’s expectations are in line with that of the sponsor’s.
Ultimately, the role sites and patients can play in your clinical supply design and planning is crucial. Everyone from the site coordinator, the medical monitor and the patient must all stand to benefit from your clinical supply chain. Therefore it’s crucial to ensure the needs of your supply chain correspond with the staff onsite as well as the patients’. This can aid in avoiding problems with dispensing on sites, while reducing issues that can occur at study start up. And lastly, don’t forget the importance of communication tools and services that can enhance supply chain processes by improving customer interface, but ultimately sponsor credibility.
*Adapted from ‘Clinical Supply Management: A Clinical Site Perspective’, a presentation delivered by Peter Trimboli, Bristol-Myers Squibb, at Clinical Trial Supply East 2016