Managing the supply chain for Investigator Initiated Trials often comes with the challenge of working with less experienced Sponsor-Investigators. Clinical supplies is usually an afterthought during the planning stages of an IIT. These types of trials go by many names, including Investigator Initiated Trials, Investigator Initiated Studies, Investigator Sponsored Trials, Non-Registration Trials, Third Party Studies, Externally Sponsored Research or Medical School Grants. For clarity, we refer to the studies here as Investigator Initiated Trials (IITs).
"Having worked on IITs for some time now, I am pleased to share my top 7 tips on how to improve your supply chain when working on these trials. In essence, the key to success is to start planning early, i.e. immediately after proposal approval.”
1. Understand the Sponsor Site’s Infrastructure: Resources and oversight are usually limited for IITs.
- Understand how much staff is dedicated to the study and assess their knowledge regarding clinical supplies i.e., do they have product blinding methods in place to decrease the risk of bias? Do they have adequate storage for the product?
- Recommend a study start-up meeting with the Sponsor site’s study staff to review supply chain roles and responsibilities.
- Ensure roles and responsibilities are defined in the protocol and/or contract.
2. Define the Distribution Strategy: IITs are becoming larger with multiple countries and sites involved. In the early planning stages, it’s important to take note of the following points:
- List all countries involved and define depots that will be used
- Understand lead times for customs clearance
- Implement cold chain strategies and define temperature monitoring responsibilities (if needed)
- Will there be direct-to-site shipments or one bulk shipment to the Sponsor-Investigator with onward distribution to the sub-sites?
- Define the process for reconciliation and destruction of the product at study close
3. Agree on a Comparator Sourcing Strategy: Many IITs are now using more than one study drug. Sponsor-Investigators are requesting assistance in sourcing comparator or standard of care. How will these requests be handled? It’s important to begin planning a comparator sourcing strategy before the clinical trial begins, preferably during protocol development.
4. Consider Label Types & Supply Options: IITs are becoming more complex and there are many decisions to be made in terms of label design and strategy.
- What type of label will be needed? How many translations are required and does the Sponsor-Investigator require regulatory guidance on translations?
- Who will be responsible for labeling the product and distributing to the Sponsor site and sub-sites?
- Is there an opportunity to use a pooled supply strategy by implementing variable text on custom labels? Using a pooled supply strategy allows you to manage supplies across an entire program instead of managing each IIT separately. This strategy can help leverage your supply and minimize costs.
5. Define the Drug Order Process: Most IITs do not have the financial support to implement an IRT. It’s important to define the drug ordering process up front because Sponsor-Investigators expect fast turnaround times when drug is requested, especially in oncology indications. This is an opportunity to bridge the gap between clinical operations and clinical supply teams.
- What documentation will be used?
- Who will be responsible for ensuring the site is in good regulatory standing before the product is shipped?
- What is the lead time between submitting the drug order request and delivering the product?
- What is the process for generating randomization lists and distributing to the site?
6. Collaborate on the Forecasting Strategy: Forecasting is usually an afterthought for IITs because it’s assumed that the Sponsor-Investigator is forecasting their demand on a regular basis and providing updates to the manufacturer. Is this really happening? Who will obtain enrollment information and timelines from the Sponsor-Investigator and translate this information to plan for future re-supplies, packaging campaigns, expiry updating etc.? Ensure the Sponsor-Investigator understands the lead times for re-supply activities.
7. Continuously monitor the supply chain. Supply chain oversight is imperative; it’s important to continue to monitor the different parts of the supply chain throughout the IITs lifecycle. The protocol can change in the middle of the study and the team needs to be prepared to make changes to labels, depots, forecasting etc. in a timely manner in order to not disrupt patient treatment.
In summary, managing clinical supplies for IITs is becoming more and more challenging, especially when working with a less experienced Sponsor-Investigator. Success requires planning, evaluating and managing the multiple aspects of the supply chain prior to the first patient enrolling. Following these clinical supply tips could make the difference!