Ian Hoban: The sourcing, transportation and delivery of comparators for a clinical study are all part of a complex process involving a myriad of stakeholders. One of the biggest mistakes we can make is to view the comparator component as a commodity item that requires us to pay less attention to [it] than other elements when designing the trial.
A good starting point should be determining the worstcase scenario or scenarios, namely, something that might possibly lead to a severe delay to the trial start date, or a disruption in supply happening mid-trial. Such issues will invariably lead to severe knock-on effects to the study end date and can ultimately affect the sponsor obtaining a timely marketing authorisation.
Additionally, we are all aware that such delays generally impact market analysts' value of a sponsor organisation, which can sometimes be catastrophic. If plan A fails, then plan B or C can be implemented without causing undue disruption and firefighting further down the road can be avoided.
The time to engage with your comparator partner is at an early enough stage to ensure robust sourcing contingency plans are in place right from the start. Far better this than involving them during the course of the study in order to come up with an emergency rescue plan. So, in effect, planning for the worst-case scenario can set you on the right course when sourcing a comparator. It is easy to neglect getting into the detailed planning for comparator sourcing until it is a little too late in the planning process. Best practice should be for sponsors to set out a plan for sourcing comparators by a certain date and working back from there.
Ultimately, it's difficult to place a set time frame on comparator sourcing, which is why it's important to understand the market dynamics and recognise this will be unique for every brand, so do not assume a time frame based on experience with a different product in a previous trial. In fact, the market availability of an individual product can shift dramatically over time and differ greatly from any previous experience you may have had - so the thing to do is test all assumptions you may have before building them into your plan.
Sponsors have to really consider what they are trying to achieve and where they're trying to achieve it in relation to their comparator sourcing strategy, which should lead to myriad questions, including the following:
By sourcing larger quantities, sponsors can carry out packaging and labelling for study purposes as a one-off cost, rather than in multiples. Typically, products have their own profile on what's available in the market and what's available from the manufacturer's likely lead times. This can guide sponsors on the correct course of action to take. Although this list is not by any means exhaustive, the answers to these key strategic questions will invariably enable clinical trial designers to make the correct decisions based on some real insights of the current and likely future availability of stock. Early preparation and having a detailed strategic overview of the commercial environment will enable them to plan and execute the best possible comparator sourcing solutions when planning a clinical trial.