Sourcing comparators can present a number of logistical and regulatory issues for clinical trial sponsors across the world. 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 than other elements when designing the trial.
What scenarios should I be planning for?
A good starting point should be determining the worst case scenario(s), namely, something that might possibly lead to a severe delay to the trial start date, or a disruption in supply happening mid-trial, etc. 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 authorization.
Additionally, we are all aware that such delays generally impact market analysts’ value of a sponsor organization, 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.
When should I start planning?
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 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 timeframe on comparator sourcing, which is why it’s important to understand the market dynamics. Moreover, it’s essential to recognize this will be unique for every brand, so do not assume a timeframe 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. Therefore, the thing to do is test all assumptions you may have before building them into your plan.
What are the key questions I should be asking myself?
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 a myriad of questions, including the following:
- What countries and markets are the trial sites contained within?
- What markets are comparators being sourced from and are they large enough to sustain the required demand, and if not, which markets are appropriate?
- What are the destination points for the product? As this will determine to a large point, what product documentation is needed, what the tax and customs regulations/tariffs are, and the lead times needed when applying for certification. This is clearly key in enabling freer movement from market to market at the sharp end of the trial.
- What back-up plans should be included to mitigate unforeseen circumstances, such as customs hold-ups, to ensure product integrity is maintained?
- Do I want to share trial details with the comparator manufacturer, and if not, am I fully aware of and happy with the limitations this may result in?
- What quality documentation is required and is it freely available?
- What’s the optimum sourcing channel – direct, open market or blended?
- What commercial market intelligence do I have, and is it current and detailed enough to avoid potential supply disruptions?
- Can I get more insight on this from my comparator partner?
- What is a reasonable and practically achievable batch size, and how many batches will be required? — By sourcing larger quantities, sponsors can carry out packaging and labelling for study purposes as a one-off cost, rather than in multiples. However, this is where expiry date availability becomes a factor. 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.
- What presentation should I be sourcing and what impact does this have on availability?
- What should the forecast schedule for the lifetime of the product look like to ensure realistic, secure and timely resupply from supply my sources? What impact might this have on product wastage?
Although this list is not by any means exhaustive, the answers to these key strategic questions will invariably enable you 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 you to plan and execute the best possible comparator sourcing solutions when you are planning your clinical trial.