Every day, the news media shares exciting new discoveries and technology that may one day provide patients with better options for the detection and treatment of breast cancer, but many of these discoveries are not evidence-based like the current standards of care. Evidence-based medicine provides patients with high-quality care through new discoveries that come from the latest research and expert findings.
As a trusted source of breast health information, Susan G. Komen supports new treatments and technologies that are evidence-based and will bring the greatest benefits to patients. The path from the lab to the clinic is never fast or easy. In fact, it takes an average of 12 years for a new drug to go through testing and approval before it is considered safe and effective for patients. For a medical device, such as a mammogram or ultrasound machine, this process can take three to seven years. Research to develop these products can also cost millions of dollars. But how does a new drug or medical device become a standard of care?
Step 1: The Birth of an Idea
The process of developing a new drug or device (called a product) begins with researchers seeing an unmet need or an opportunity for improvement in the current standard of care. Research for these new products begins in a lab. For medical devices, researchers must create a concept or prototype to see if it works correctly.
Step 2: Testing and Clinical Trials
New products must undergo lab and animal testing to answer basic questions to show they are safe to test in people. If this “preclinical” research is successful, they will advance to more in-depth studies known as clinical research. Because it often takes a lot of money to move a product forward to clinical testing, many drugs and devices never make it out of the preclinical phase.
For those that do, the next few years are full of testing and reporting of data. New drugs are put through several phases of clinical trials to test overall safety and efficacy for people. Phase 1 clinical trials focus on safety and the proper dosage, phase 2 trials focus on a drug’s effectiveness and side effects, and phase 3 trials compare the new drug to existing treatments.
In contrast, medical devices are tested and approved according to their classes. Class I devices are those with the lowest risk to people and require less monitoring to ensure safety and effectiveness. Class II and III devices are higher risk and require more evidence of their safety and effectiveness over time.
Step 3: FDA Review and Approval
Once all testing is complete, researchers can file an application to market the new drug or medical device to the public. Before this happens, the FDA must review all documentation, from preliminary testing to the results. Sometimes, additional studies are needed before the FDA will grant final approval.
While drugs and devices can both receive FDA approval, it is important to note that the processes are very different. For a drug, FDA approval means it has been shown to be effective in treating people with a particular health condition, such as breast cancer, in clinical trials. For a screening tool or other device, FDA approval means it’s safe and works like an existing tool, but it doesn’t mean it does what it’s intended to do, such as find breast cancers early. Clinical trials are needed to find out whether a tool or device is effective – and clinical trials are not required for FDA approval of screening tools or devices.
Step 4: FDA Monitoring for Safety
Once an approved product is available to the public, the FDA will monitor its use to make sure it is safe and effective. Drug manufacturers will send periodic safety updates to the FDA. Medical device manufacturers will have both scheduled and unexpected visits from the FDA to their facilities to make sure developers are following good manufacturing practices. The FDA also has programs for both drugs and devices that allow users and manufacturers to report any problems with safety or effectiveness.
Conclusion
Development of a new drug or medical device is a long and expensive process, and many products never make it through all the steps that lead to FDA approval. Once a product is FDA-approved, researchers can discuss where it fits within the current standard of care and where it will provide the most benefit to patients. Komen supports the ongoing efforts of scientists whose research makes these new discoveries possible.
For more information about some of the latest treatments and technologies currently being tested in clinical trials, visit our What’s New in Breast Cancer page.
