Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?
Over the next few weeks, stay tuned to PSI On Point to learn about “seven deadly sins” of trial supply management, brought to you by PSI Trial Supply Manager, Alan Morton.
Last week, we looked at the deadly sin of pride. Don’t forget – we all, always, need to learn and improve. This week, we’re diving back in and looking at our final warning sign… envy….
Envy (They’re getting the job done quicker than us, how can we stop them from making us look bad?)
For a number of reasons, there will occasionally be more than one CRO working on a study at the same time. This can sometimes cause problems behind the scenes.
PSI was recently brought on to a study to boost recruitment that was way behind schedule. However, the incumbent CRO remained in control of the drug supplies. Shortly after we got going, we were able to recruit patients far faster than the other CRO, but soon found that the drug supplies needed to treat the patients were subject to delays and stock-outs. Though this was an issue that affected the entire study, it was also a positive learning outcome for risks associated with splitting the study across two organizations.
Don’t Let The Rush Overcome The Supply
It takes significant resources –time and money- to identify a patient, screen, enroll and start treatment. It is unforgivable (as well as unethical) to allow this to happen, and then not have the supplies available to treat them when they arrive at the site.
In order to prevent this, we need to be clear with the sponsor about our expected recruitment forecasts and discuss variations – especially when recruitment is faster than expected. This will then show how much supply we will need at each point. If it becomes clear that the supplies will not be available, then we should slow recruitment rather than risk running out of drugs for ongoing patients.
Moving Ahead: Mitigation and Planning
Now that we understand the major pitfalls that can cause problems during the course of a study (remember the other 6 sins we previously discussed?), we need to understand what we can do to avoid them. Setting milestones or checkpoints along the course of a study will help ensure that reviews are carried out in good time. Think about it: how often do even the best of the best project managers need to rely on the goodwill of others to help avoid a crisis by prioritizing work when slightly better planning and more timely decision making could have avoided the issue altogether?
The pointers below are a cyclical process, which has been used in a number of forms and is a key part of all good project management toolkits.
- Plan Focus on the end goal and identify what we need to do to achieve that goal
- Assess the risks Weigh the options and review the cost/benefit analysis, and mitigate against risks that can’t be avoided
- Develop a strategy Break the plan up into milestones and work out the timelines
- Execute Use the plan as a guide. Focus on timelines and deliverables. Be aware of risks happening and take action when they do.
- Evaluate progress Compare real-life with the forecast. It is a lot easier to get a plan back on track if action is taken early.
- Re-plan When life happens, update the plan with the new information
- Communicate Make sure that when the plan changes, the relevant people know, and most importantly, know what they now need to do.
We know that mistakes are all too common in trials. And when a trial is split between two CROs, the risk of these mistakes can be even larger. It’s more important now that ever to ensure solid planning, analytical strategies, and appropriate mitigation options. Don’t let envy, and the feeling of “competing” against the other organization, ruin a well-designed study strategy.
And remember, your supplies and logistical aspects matter. As we mentioned before, running out of supplies is both unforgivable, and unethical.
Alan Morton, Trial Supply Manager
Alan has been working in the logistics and supply chain arena for almost 30 years and has spent the last 7 working for market-leading drug supply and packaging vendors supporting studies all over the world.