Introduction: Understanding Clinical Trials vs. FDA Approved Treatments: What’s the Difference?
When managing a health condition, patients often have the option to choose between FDA approved treatments and clinical trials. FDA approved treatments involve established medications or therapies that have been proven effective over time and are widely used.
Alternatively, clinical trials offer the opportunity to access investigational therapies and treatments that may not yet be available to the public. These trials, particularly in clinical drug research studies or randomized research studies, explore new ways to treat conditions, potentially offering patients access to investigational treatments before they may be approved for general use.
Let’s explore both in detail to understand how they work and how they can impact your decision while on your health journey.
What are FDA approved Treatments?
FDA approved treatments refer to established therapies that are available to the public, are supported by scientific evidence, and have undergone extensive clinical trial testing to demonstrate their safety and effectiveness. These treatments may include:
- Medications
- Surgical procedures
- Physical therapy
Overview of FDA approved Treatments:
- Proven Safety and Efficacy: FDA approved treatments have undergone clinical trials and real-world application, providing confidence in their safety and effectiveness.
- Widespread Accessibility: These treatments are widely available in hospitals, clinics, and pharmacies around the world.
- Predictable Outcomes: Because FDA approved treatments have been studied for years, healthcare providers have a clear understanding of the expected outcomes and side effects.
What are Clinical Trials?
Clinical trials, as discussed in-depth in AutoCruitment’s other blog are research studies that explore new or experimental investigational treatments, drugs, or medical devices. These trials are designed to test the safety, efficacy, and potential benefits of investigational treatments that have not yet been approved by regulatory agencies like the FDA. Clinical trials are organized in phases (from I to IV), each with different objectives, including testing safety, dosage, side effects, and effectiveness and post approvals by the FDA.
Overview of Clinical Trials:
- Access to Investigational Treatments: Clinical trials provide access to investigational treatments and experimental therapies that may not yet be available to the public.
- Contribution to Medical Research: By participating in clinical trials, patients contribute to advancing medical knowledge, potentially helping current and future generations.
- Close Monitoring: Participants in clinical trials receive closer monitoring with check-ups on a set schedule and assessments to track progress and side effects.
Choosing between FDA approved treatments and clinical trials is a deeply personal decision that depends on your health goals, risk tolerance, and willingness to explore investigational therapies. We recommend talking to your doctor about participation.
To explore how to choose the right clinical trial for you, download our free guide.
Conclusion: What’s the Right Choice for You?
The key difference between FDA approved treatments and clinical trials lies in the approach to study-related care. While FDA approved treatments are based on proven, established methods, clinical trials test investigational therapies that may offer benefits if the treatment is proven effective, but come with additional risks.
If you’re considering participating in a clinical trial, it’s essential to have a thorough understanding of what you’re getting into. Read more about the safety and side effects of a clinical trial here.