In the modern world's financial situation, globalization of pharmacological products have become the main reason for success for many drug related companies. Investors of more recent drugs are, therefore, requiring manufacturers to do more work at a lower cost and a quicker turnaround time. Consequently, they are facing newer challenges, as well. One of the main setbacks, currently, to globalize a product is the ethnic factor.
What are Bridging Studies?
Bridging studies in clinical trials have been designed specifically to bridge' the gap between different countries and cultures knowledge about the outcomes of drugs among different populations.
The difference between populations may be ethnicity but geographical location may be the reason on its own. Bridging studies let separate countries work out how drugs effect different ethnicities, as different populations have evolved slight differences in receptor and enzyme makeup, meaning that drugs could have a massively different outcome between someone from one population to another.
How did they start?
Pharmaceutical sponsors started to become increasingly concerned with the global development of drugs in the early half of the 1990's. The sensitivity to different ethnicities regarding how drugs were developed and the effects they had, therefore, was given a great deal of attention from sponsors as well as regulatory authorities.
As ethnic factors had the potential to affect a drug's efficacy and dosage to different populations, different countries were starting to be required to do bridging studies in order to find out how their drugs affected different ethnicities.
To fix this problem, in 1998, the International Conference on Harmonization (ICH) presented a standard guide called the “Ethnic Factors in the Acceptability of Foreign Clinical Data”. This guideline suggests an overall summary for measuring the effect of ethnic factors upon a medicine's efficacy, safety, and dose response.
Why are they important?
If a drug or vaccine works well within a certain ethnic group where the study is originally done, then the same study has to be done to another ethnic group from a dissimilar population to see if the same amount of drugs works in the same way or if there are slight differences.
Whilst it is important to understand that some drugs will affect the efficacy or dose among different ethnicities, it is also as important to note that many drugs have similar characteristics across different regions. Bridging studies are a regular requirement for all new drugs or vaccines but they also waste precious time as they delay their production to people who need them and cause longer wait times to new therapies.