Comparator clinical trials are becoming increasingly important for companies that want to prove the effectiveness of their product. Unlike trials that use a placebo, comparator clinical trials compare a new medication to a drug that is already approved for use on the market. This allows a company to prove that its new drug is safer or more effective than a current treatment option, which helps when applying for FDA approval.
However, conducting comparator clinical trials can often be an arduous task for drug companies, especially when it comes to sourcing an appropriate comparator drug. Interestingly, in an attempt to combat some of the main sourcing issues, many sponsors are now choosing to turn to newly emerging markets for their sourcing needs, overlooking the more established markets in the US and the EU.
This is not always an effective or suitable strategy, and new problems can arise, but sourcing from these markets can be beneficial to a trial sponsor in a number of ways;
- Value for money – in general, comparator drugs are less expensive in emerging regions like Asia and Latin America than they are in North America and Europe. However, it is important to balance these cheaper costs against the potentially higher transportation costs, as well as the difficulties that might arise when trying to export drugs out of these countries.
- Availability – sometimes trial sponsors find that they cannot obtain a sufficient supply of a comparator drug from North America or Europe, often because the manufacturers in those regions do not want to support the development of a competitor product and so make the process difficult. In cases like this, it can be easier to meet supply needs in emerging regions.
- Improved transparency and safety – in the past, trial sponsors have been wary of emerging markets as the regulatory infrastructure in these countries is not always as developed or streamlined as it is in North America and Europe. This can lead to lower quality of product or increased opportunity for counterfeit drugs to enter the market. However, many countries have made serious efforts to change this. India, for example, has created the Indian Clinical Trials Registry, which is in charge of properly monitoring clinical trial drug sourcing within the country. China, too, has made serious efforts to clean up its regulatory system in the past few years, especially with regards to intellectual property (IP) rights and patent protection.
However, despite the benefits listed above, a trial sponsor can still face significant challenges when sourcing from emerging markets. It is important, therefore, for a trial sponsor looking to source from these markets to plan early in order to mitigate risk.