Bridging studies were not done in the past, but as pharmaceutical companies chose to broaden their client base by taking their medications international, the need for bridging studies became apparent. There are a number of things that bridging studies can help to determine. They can verify efficacy and safety of certain compounds that are used in medications, they can ascertain the sensitivity of a drug when it is used in a new ethnic region, they can help to minimize clinical data duplication so that new therapies can be developed, and they can improve efficiency so that resources are not wasted. The studies can help in the registration process with regulatory authorities in various regions as well. Getting a drug approved for use is often hard to do, but bridging studies can help to streamline the process.
Why Bridging Studies Are So Vital
The studies are conducted so extensively, because regulatory authorities need proof that the drugs will not cause adverse effects. Foreign countries do not rely on clinical data from other countries alone. They will take the foreign clinical data, and compare it to their own bridging study results to see if any questions arise about the effectiveness of the drug or the side effects that come along with using is. One of the reasons why this testing is so critical, is because the adverse effects often aren’t seen in the early stages of clinical trials, so more in-depth studies are needed to test the effects of the drug long-term.
The Importance of Testing in Multiple Ethnic Groups
It is essential that clinical study results are consistent across all ethnic regions. If there is a discrepancy in even the smallest detail, then questions will need to be answered about why the results are different. Just because a drug has been tested in one region, and has been found to be safe, that doesn’t mean that the drug is actually safe for everyone to use. Not all ethnic groups have the same biological characteristics, so the drug could cause negative effects in certain groups. Part of the reason why bridging studies are conducted is to avoid this scenario. Drug manufacturers need the data, so that they can determine how to make the drug safe for everyone, no matter what region of the world that they are from. The goal is to have similar results across all ethic regions, so that researchers can ascertain whether or not the difference in effects is down to ethnicity or not.
Global Bridging Studies Provider
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