The pharmaceutical industry is expanding at incredible pace and manufacturers are now being expected to produce more for less cost and in a shorter amount of time as they respond to global health needs. One of the biggest areas of concern with clinical trials is that safety and effectiveness is tested on different ethnicities. The way a drug is metabolised can differ for different populations and manufacturers need to know how their initial trials on a small group of participants will translate when introduced to a new region. This is how bridging studies have gained importance.
A bridging study can be defined as an additional study in a new region to bring together clinical data from foreign studies. It acts as a bridge of information between results found in the new region and the results from the original tests performed in a different population. For more information on the benefits of Bridging Studies, go to https://www.richmondpharmacology.com/specialist-services/bridging-studies
Ethnic factors can impact a drug’s safety, efficacy and dosage requirements so it is essential that manufacturers carry out these bridging studies, often at the request of regulatory bodies. The history of such studies began in 1998 when the International Conference on Harmonisation instigated a guideline called ‘Ethnic factors in the acceptability of foreign clinical data’. The guideline contained advice on assessing the impact of a drug’s response in different populations.
There are many ways that different regions differ both in external and internal factors and therefore, a drug may react differently too. Internal factors include genetics, pathological and physiological factors, race and genetic diseases. External factors include things like climate, pollution levels, socioeconomic factors, levels of healthcare, smoking, alcohol and food habits.
For example, a drug may work excellently in one population but questions arise as to how well it will perform in different circumstances and different populations. Additional studies are often required for approval in a new region precisely for this reason – there are too many unknowns if the new region differs significantly in ethnic terms to the original test population.
Drugs often have similar effects regardless of ethnicity and additional studies are costly and time consuming. This is why bridging studies have become so popular as they provide solutions to the potential for delays to accessing new treatments and hold ups due to regulatory compliance issues.
A bridging study removes the potential for duplication of testing and effort and only requires specific tests to ensure the safety and efficacy of a new treatment in a new region. By doing away with the need to start a trial over again from the beginning, researchers can use their existing data and the data from additional tests.
Bridging studies can also be utilised when there is a change to the manufacturing processes for whatever reason that might have an impact on the dosage, efficacy or safety of the product. This might be a change in storage, packaging or preparation processes that need to be modified.