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1) 10 Ways to Reduce the Risk of Comparator Drug Sourcing
2) Health Reformers Seek Effectiveness Data
(PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: PAUL A. BELCI)
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As a population, we have greater access to information than ever before. Couple this with challenging economic times and the
result is an environment in which things are no longer accepted at face value. This trend is impacting all industries, including
drug development.
The State of Comparative Effectiveness
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Given this climate, intensified interest in comparative trials should come as no surprise.1,2,3 Economists, insurers, health care professionals, and the public seek more compelling evidence on how drugs compare in safety,
efficacy, and cost. At the same time, governments around the world are promoting the use of comparative effectiveness trials
in an attempt to control the inflation of health care costs and provide additional information in support of the approval
process (see sidebar).
Investment in these trials is expected to increase as companies seek to better demonstrate the value of new therapies and
make the case for inclusion in hospital and government formularies and reimbursement under insurance coverage.
Comparative effectiveness studies for new drugs, however, are not yet commonplace. Most often, clinical trials compare investigational
drugs to placebos rather than subjecting the drugs to rigorous evaluation against existing treatments. While comparison against
a placebo is generally required by regulatory authorities, trials must also include an active comparator when a pharmaceutical
company seeks to claim superiority versus the competitor drug in its marketing materials; or an active comparator may be the
only control agent in cases where giving trial participants a placebo would not be ethical.
As pressure mounts to conduct comparative effectiveness trials, pharma companies 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.
Get strategic
Sourcing and supplying comparator drugs for global clinical trials presents a number of obstacles and potential pitfalls for
the trial sponsor.
The inability to obtain the necessary pedigree and product documentation for the comparator, lack of supply chain security
with possible introduction of counterfeit comparators, and delays in resupply throughout the course of the trial are some
of the problems that can lead to significant operational, regulatory, and financial setbacks for the trial sponsor. As such,
drug developers must have a comprehensive view of what is involved in the process and formulate a customized, strategic approach
to best support their trials.
To minimize the risk of delayed or interrupted clinical trials and the financial implications that can result, a comparator
sourcing and supply strategy should include a number of elements. These include demand planning that can accommodate changes
in the quantity of comparator drug needed in light of fluctuating patient enrollment or unexpected changes to a trial; changes
in regulatory opinion, or temporary or permanent regulatory noncompliance by the source manufacturer; loss of the project's
consulting global regulatory expertise; changes in global sourcing capabilities and logistics; and loss of connection to the
comparator manufacturer via a sourcing specialist.
Exposure to operational, regulatory, and financial risks can increase if comparator sourcing is considered a series of transactional
events (e.g., buying a comparator from a wholesaler as needed) rather than a process requiring a well thought-out strategy.
In situations where sourcing becomes an afterthought amidst all of the other trial requirements, a transactional approach
vs a strategic approach to supplying comparator drugs can jeopardize the progress of a trial.
Timing is everything
Probably one of the simplest ways to reduce risk during the comparator sourcing process is to start planning early, typically
during the protocol design phase.
A head start on planning is imperative, as comparator drugs are likely to be available from a wide variety of sources across
a number of geographies. Each source, however, may exhibit regional variations and will be governed by different trade regulations,
all of which must be considered prior to selecting the most appropriate source.
Advance planning allows time to:
- Properly assess options, availability, and limitations for sourcing the desired comparator
- Evaluate regional variations of comparators, including dosage form, strength, API concentration, visual aspect, and intracountry
regulatory agreements related to the equivalency of different comparators
- Review sourcing options for regulatory requirements, packaging, reformulation, blinding, and relabeling needs
- Establish required volume/quantities and delivery schedule
- Evaluate price and total cost of acquisition of comparator
- Confirm availability of required pedigree and product documentation.
