Sourcing Comparator Drugs for Global Clinical Trials
Increasing emphasis on the comparative effectiveness of pharmaceutical treatments has in recent years translated into a growing expectation for developers to prove the relative benefits of their new medicines during the clinical trial process. Under ordinary circumstances, the process of sourcing comparator drugs poses distinct challenges, but when studies are conducted on a global scale the issues are magnified. With pressure mounting for drug developers to carry out comparative effectiveness trials more frequently, sponsors need to have in place a robust strategy to first of all select and appropriate comparator product and then ensure that its supply can be maintained consistently and cost-effectively across all trial sites, wherever in the world they may be.
At a very basic level, comparator sourcing involves comparing existing pharmaceutical products with those still in development, usually to prove that a new treatment is more effective or works faster than its predecessors. "Most of the time, this is done for best in class, and is usually done during Phase II or III studies," explained Lekishia White, vice president at MultiPharma, in a recent interview with Genetic Engineering & Biotechnology News (GEN). "Comparative trials are prevalent, especially with increasing pressure to get the best drug on the market," she added.
But there is usually a specific set of risks involved with such studies. For instance, most companies would not want rival firms to be aware of the fact that they are comparing the benefits and effectiveness of their medicine to another. However, as Ms White pointed out, such details regularly enter the public domain as clinical trial information usually has to be revealed to the authorities, such as the Food and Drug Administration (FDA) in the US. And even if the new product has not brought any improvement to the treatment of a condition, the firm may still be obligated to share its results.
"This is why drug development is so expensive. There is such a small percentage that makes it through the entire cycle. You could get through trials with a working therapy, but it may not be best in class, so the company decides not to develop it," Ms White went on to say. One of the distinct challenges facing developers when involved with comparator sourcing is getting together all the necessary documentation. Companies will need to obtain a certificate of analysis, or equivalency paperwork, as well as formal approval to use the materials.
"There may be a drug registered and available in Europe, but not in the US. That would require an equivalency statement that ensures it's the same formulation," Ms White told GEN in March 2011. She also explained how different comparator sourcing providers specialise in the areas they service most. "Some of us have better relationships with the innovator companies than others. It's about relationship building." And the best way for companies to know which provider to use is often to attend industry meetings and conferences, she added.
"The clinical trial circle of influence is quite small - word gets around quickly who is reliable and who is best. There are at least ten comparative-sourcing providers - for such a small niche market, that's a lot." In fact, the field is a growing area, with the number of providers having doubled in the past few years. Clinical research organisations (CROs) undoubtedly have a key role to play in the future of global drug development – and in the sourcing of drugs for comparative study.
Decisions over when to rely on in-house resources and where the services of CROs can be strategically beneficial are pivotal in terms of whether or not a new drug is going to make it to market. The latest research suggests that biopharma currently outsources a third of all clinical research. As the need for consistent and cost-effective comparator sourcing grows, this proportion is likely to increase accordingly.