Should we re-direct our efforts from detailed forecasting to building flexibility
and the ability to respond to changes into our supply chain"is that clinical trial supplies optimization?
Time and time again I have watched people spend hours in a vain attempt to produce the perfect forecast only to see the "perfect" forecast amended again the following week and the week after.
It is clear that we all need some level of forecast in order to manage resources but should this forecast be at a higher more generic level with an increased focus on the ability to respond to changes. For example when setting up the IRT or IVRS systems for a study and requesting quotes from potential vendors, how many of us actually assess the cost and time impact of potential future changes?
You could well argue that it is impossible to predict the changes required, therefore how can you be expected to measure the cost and time impact of something that is unknown? I would argue that whilst the specific changes required may not be visible at the start of a clinical study there is no reason why we cannot work with our vendors to make system and supply chain design as flexible as possible. A number of IRT or IVRS vendors have now established modular systems that are able to respond more quickly and more cost effectively to changes required whilst the system is live.
Some other areas that should be considered when designing flexibility into a supply chain are kit design and label design. Kits should be designed to provide maximum flexibility to allow for unforeseen adjustments is dose or visit frequency. Do you routinely consider which countries are likely to be added as contingencies if recruitment doesn"t go as planned and if these are known are country requirements and languages for contingent regions included in the booklet label from the start?
There are numerous simulation and clinical trial supplies optimization and forecasting tools available on the market that are designed to make the process more accurate and to an extent they probably do add some value. However as the data going in is usually based on best guess and assumptions it is inevitable that the forecast coming out, whilst an improvement on the more traditional spread sheet or paper based approach, will never be 100% accurate. Until we find the perfect crystal ball I would encourage each of us to keep the word flexibility at the forefront of our planning activities.