Mitigating Operational Risk in Comparator Sourcing
Comparator effectiveness studies are growing in prominence within the pharmaceutical industry. This is due to an increasing onus on drug developers to carry out comparator effectiveness studies, however, this has not been coupled with significant improvements in comparator sourcing.
Sponsors planning to conduct such trials are likely to face difficulties in sourcing comparator drugs, a particular issue as efforts are being made to cut the time drugs take to get to market. These include a lack of correct documentation and possible supply chain issues – all of which expose the clinical trial to a range of risks.
In a Contract Pharma article entitled Reducing the Risk of Comparator Sourcing, Andrea Chopek, director, Strategic Comparator Supply for Idis, Inc. said: "As pressure mounts to conduct comparative effectiveness trials, trial sponsors must put in place robust strategies to first select a comparator drug and then source and supply that drug, in an uninterrupted manner, to all trial sites in a cost-effective manner."
Comparative effectiveness research in the real-world
The American Recovery and Reinvestment Act set aside $1.1 billion (£704 million) for comparator research in the United States, with the intention of providing patients with more reliable information on the treatments available.
"Comparative effectiveness differs from efficacy research because it is ultimately applicable to real-world needs and decisions faced by patients, clinicians, and other decision makers," a report by the Department of Health and Human Services to congress and the president stated.
It claimed that comparator effectiveness research is capable of going hand-in-hand with the trend towards personalised medicines, stating one of the main benefits of "investigate effects at the sub-group level that often cannot be determined in a randomised trial".
While the funding provided through the scheme is to be used for public sector research, the intention is to link with activities within the private sector, with the purpose of maximising benefits for the American people.
Transactional sourcing challenges
Drug developers have traditionally taken a transactional approach to comparator sourcing, whereby comparator drugs were requested with a very short amount of time to spare.
This meant procurement professionals sought the products from wholesalers. These wholesalers would all have to be vetted to ensure they meet required standards in advance and even then may not be able to provide the large supply needed at short notice, with the necessary paperwork needed for rigorous comparator effectiveness research.
"Wholesalers may not be able to provide large single-lot batches with long expiration dates. The purchasing company may have to buy the comparator in multiple lots, reducing clinical consistency, and creating a significant challenge should there be a recall," said Chopek.
Many were also not up to date with the regulatory environment surrounding clinical trials; a particular concern as rules tighten and research spans an increasing number of multinational boundaries.
Towards strategic comparator sourcing
In contrast with a transactional approach, strategic sourcing involves more forward planning but comes accompanied by lower risks.
Previous articles on the subject have claimed there are a number of key factors when devising a strategic sourcing strategy.
Firstly, unlike when a transactional approach is taken, companies must allow the longest amount of time possible for the sourcing of the comparator drug. This will allow for sourcing from the most suitable provider, reducing the risk of delays later down the line.
Using a comparator sourcing specialist should also be a consideration for those implementing a strategic sourcing approach. These will likely have a relationship with the manufacturer of the comparator drug which a wholesaler will not and be better able to get the large batches needed, with a suitable shelf life, in advance of the drugs being needed.
Sourcing directly from the manufacturer, which may be reluctant to deal with a company working on a possible competitor to its compound, also increases the chances of the drugs arriving with the correct paperwork and cuts the opportunities for counterfeit products entering the supply chain.
To deal with the increasingly global nature of clinical trials, those devising a strategic sourcing must have an understanding of the world-wide regulatory landscape and plan in advance to deal with any possible distribution delays, or any other unexpected changes within the trial.
While a transactional approach is likely to be the only option when little time is available, a strategic approach will reduce the risk of delays and companies running into regulatory hurdles later down the line.