In short - the screening period could either cost or save you a bunch of money, depending on how you design it!
First a little bit of context — experienced clinical supplies readers please skip the next paragraph.
In most interventional clinical trials involving drugs, subjects first go through a screening visit, where a series of background and medical checks are performed to determine whether they are eligible. Upon successful screening, they are then scheduled for randomization (if applicable) and one or more subsequent visits at which the investigational product and possibly additional drugs are dispensed. Usually no drug is dispensed at screening.
The duration of screening as described in the protocol is driven by the analysis and tests to be performed. Since those tests are variable in duration, often only an upper bound on this screening period is given, e.g. maximum 14 days. This contrasts with the rest of the visit schedule, which is usually less variable, e.g. patients are scheduled every 30 days ±3 days.
Screening may take anywhere between 1 and 14 days ...
This variable and potentially short screening period implies that drug must be available on all sites and for all treatment arms to allow for randomisation of subjects.
For example, let us consider a realistic trial with 2 treatment arms and a dispensing of several drugs on a bi-weekly basis after randomisation. Let us say we expect 500 subjects on 100 clinical sites. The screening period is "at most 14 days". Both treatment arms require a comparator coming at $2,500 per dose, and distribution also comes at $2,500 per shipment to sites.
1. You will need to seed all sites with comparator drug, e.g. 3 kits, for a total of $250,000 in shipping and another $750,000 in drugs. From those sites, one can reasonably expect that 10% will never enrol anybody, which means a net loss of $100,000.
2. You will need safety stocks throughout the enrolment period, let us say 2 kits on all active sites (e.g. with at least 1 patient randomised). This stock represents a material cost of $900,000 considering 90 active sites and 1 drug replacement due to expiration, plus $450,000 in shipping.
The cost of the screening period is estimated to $1,450,000 for this one trial!
A simple design change could save you just about that much, or potentially more depending on the trial design, complexity and costs structure.
The suggestion would be to simply set a minimum interval between screening and randomisation / first dispensing. In our example, that would be imposing that randomisation occurs at least 7 days after the screening visit. This has little impact on the trial (since 14 days is acceptable), but from a supply chain perspective, it changes the game!
Indeed in this case, reasonably considering that sites can be supplied in under a week from depots or direct-to-site shipments, we can afford not to seed sites prior to their first screened patient. Furthermore, if your IRT allows, you could use a predictive resupply algorithm with a lower or zero safety stock.
Hence, this small change could effectively save you the above $1,450,000 in this example trial!
Imposing a minimum screening period may remove the need for site seeding, and decrease or eliminate safety stocks
Unfortunately, protocol design often comes long before supply chain gets involved, and this kind of considerations do not take place. I came across such opportunities in both large and small pharmas / biotechs.
My personal opinion is that supply chain thinking should be added to the protocol design phase, so as to identify opportunities that have little impact on the chances of success of the clinical trial, but that may greatly improve supply chain efficiency.
Do you involve supply chain during the protocol design phase?
How much do you think imprecise screening period costs to your organisation?
Do you or would you apply a minimum screening period?
This is one of the many considerations that could avoid wasting a ton of money in materials and shipping to cover for your clinical supplies, and is part of Belenox's offerings. Challenge us with your protocols and see how much you could save!