Sharper comparator collaboration needed to cure clinical study delays
A recent deep dive study led by Pharma Logistics IQ has seen over 60% of respondents label comparator sourcing as a key stumbling block for losing time and money in clinical trial supply.
If left neglected, comparator sourcing can tangle into a significant supply issue within clinical research.
Only 6% of the base said that sourcing comparators is hardly ever a stumbling block for them.
Rise of comparator trials
The numbers of clinical trials comparing two active drugs, rather than testing a new drug against a placebo, are on the rise.
In a previous interview on the subject Didier Basseras, Vice President Clinical Supplies Clinical Supply Chain at Sanofi said: “Comparative sourcing is for sure one painful point, because when we want to launch a major trial where we want to measure our superiority against the best of the market, obviously speaking about competition, the lab will not help you to fight against their product.
“It is always difficult to get the product first and second to get the stability data, you have absolutely no help at this point. For instance, when you are getting a drug from the competition, [in] regards [to] the stability data, if it [requires cold chain transport] you have to consider it without any time out of refrigeration.”
Comparator supply chain
A consistent supply of comparator product is needed to minimize delays. Also, the reliability of the trial’s results depend on a guaranteed drug comparison.
Security of this supply chain is crucial to prevent a counterfeit comparator being introduced into the clinical trial, which could jeopardize results and not to mention patient safety. General trade regulations governing import and export practices also must be adhered to.
As clinical trials become more global, comparators often need bespoke labels so clinical staff understand how to handle and manage the drugs. This can add time, financial costs and potential errors to a clinical study. There are some compliance rulings that block the use of some labelling innovations for example an e-label which would present information on scanning a barcode.
Get a strategy
In response to the results Bernard Jaucot, Director Strategic Solutions, Global Clinical Supplies PPD agreed comparators are always an underestimated piece of the budget and can sometimes triple the risk for clinical suppliers.
Regarding Pharma Logistics IQ’s market research he said: “It is nice respondents are aware that comparator sourcing can be a stumbling block and you really need to have a strategy and the right expertise. I can only hope that because they know it is a stumbling block, they do something about it. I just worry they always hit the same wall but do not do anything to prevent it.”
Sourcing directly from the manufacturer can be the best way to guarantee good quality and quantity of product for a clinical trial. This method allows drug developers to purchase large, single lots of a drug with a long shelf life.
Although, purchasing companies may wish to remain anonymous as a comparator’s manufacturer may not want to sell their drug for a comparative trial that may demonstrate superiority over their own product.
Bernard Jaucot recommends: “Looking [for comparators] as soon as possible to be sure that they have good batches as well long expiry dates. The other [consideration] is to be sure that [it is] actually still on the market in a lot of countries. We have had that with clients - they discover their comparator is not on the market and [so] need to delay the whole trial.”
Comparator drug sourcing companies
Many drug developers employ specialist companies with a detailed knowledge of the global landscape to remove the burden of reliably sourcing and supplying comparator trials.
When outsourcing, pharma firms should remember to invest in their own expertise according to Bernard Jaucot: “It is not just about partnering with the right people, it is about having the right relationship with your vendors. Even if you partner with someone you still need expertise in your own company – that is often forgotten.”
Many sponsors running clinical trials struggle to get the timing right with comparator sourcing.
Pharmaceutical and biologics firms often waste time because of bad coordination when selecting comparator vendors. As a result, there isn’t enough time for the medicines to be sourced, which causes trial delays.
On the other hand, strict coordination is also needed to prevent comparator drugs being sourced too early which can lead to the medicines hitting their expiry dates on the shelf.
Steve Jacobs, Chair, Global Clinical Supplies Group said upfront communication and transparency is essential. “When something changes in a trial, typically the comparator sourcing company ends up being one of the last to know. The CRO knows, the supply chain knows, but sometimes the vendors and contractors in the comparator industry are the last to know and that becomes a nightmare for those involved.”
Sponsors must strive to collaborate better with comparator vendors, especially considering the growth ahead for clinical studies as well as the higher frequency of delicate and expensive biologic medicines.