Changes in How New Drugs Are Tested

The FDA has made several changes to the way new drugs are tested in recent years. These changes are designed to:

* Improve the efficiency and effectiveness of the drug testing process

* Protect the safety of patients

* Facilitate the development of new drugs

Some of the most significant changes to the drug testing process include:

* The use of biomarkers. Biomarkers are molecules that can be measured in the body and that indicate the presence of a disease or condition. The use of biomarkers can help researchers identify potential new drugs that are more likely to be effective in treating a specific disease.

* The use of adaptive clinical trial designs. Adaptive clinical trial designs allow researchers to modify the design of a clinical trial as it is ongoing. This can help researchers identify the most promising drugs and eliminate those that are not effective.

* The use of real-world evidence. Real-world evidence is data that is collected outside of a clinical trial setting. This type of data can help researchers understand how drugs perform in the real world and identify potential safety issues.

These changes have helped to improve the drug testing process and made it more efficient and effective. As a result, patients are now able to access new drugs more quickly and safely.

Here are some specific examples of how changes in drug testing have improved the lives of patients:

* In 2015, the FDA approved the drug nivolumab (Opdivo) for the treatment of advanced melanoma. Nivolumab is an immunotherapy drug that helps the body's immune system fight cancer. The approval of nivolumab was based on results from a clinical trial that showed that the drug was effective in shrinking tumors and improving survival rates.

* In 2016, the FDA approved the drug pembrolizumab (Keytruda) for the treatment of advanced lung cancer. Pembrolizumab is also an immunotherapy drug that helps the body's immune system fight cancer. The approval of pembrolizumab was based on results from a clinical trial that showed that the drug was effective in shrinking tumors and improving survival rates.

* In 2017, the FDA approved the drug alectinib (Alecensa) for the treatment of ALK-positive non-small cell lung cancer. Alectinib is a targeted therapy drug that blocks the growth of cancer cells. The approval of alectinib was based on results from a clinical trial that showed that the drug was effective in shrinking tumors and improving survival rates.

These are just a few examples of how changes in drug testing have improved the lives of patients. As the drug testing process continues to evolve, we can expect to see even more new drugs that are effective and safe.