What Are Clinical Trials?
Clinical trials are research studies conducted to evaluate the impact of newer medical, surgical, or behavioral interventions. They are the primary way that researchers determine if a new treatment, medication, or medical device is effective and free of adverse effects. Often, a clinical trial is used to learn if a new treatment is more effective and/or offers no or fewer harmful side effects than alternative treatments.
Clinical trials can be sponsored or funded by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs.
Sponsors design clinical trials according to rigorous scientific and ethical standards, which include oversight by an independent ethics committee and informed consent from participants.
Pros and Cons of Participating in Clinical Trials
The phases of clinical trials
Clinical trials have four phases. These phases aim to determine the appropriate dosage, test a medical treatment or drug, and search for side effects on test subjects. The FDA must approve Phases I and II before Phase 3 trials can begin. Note: Some clinical trials also have a Phase 0, which can help a research team determine whether the clinical trial should proceed.
Safety Is The Top Concern
Participating in “first in human” studies is an opportunity to contribute to advancing medical research and development. As a participant, you will play a crucial role in helping researchers investigate the safety of new medications and treatments currently being studied. The results of these studies will help determine whether the medicine is safe to use and whether it can be effective in treating specific illnesses.
Effectiveness Is The Top Concern
In the phase 2 clinical trial, the researchers determine the effective dosages of the investigated treatments. This phase also includes determining side effects and risk factors.
Effective Options Are The Top Concern
Phase 3 clinical trials consist of an even larger group of participants (sometimes worldwide). The participation you give will help researchers get a clearer picture of the treatment’s side effects and potential effectiveness.
Public Safety Is The Top Concern
Even after a treatment is approved for use, you can still be part of clinical trials and assist researchers. These “open-label studies” assist researchers with understanding risks and potential benefits over more extended periods of time.
If Phase 3 proves the experimental trial was successful, the FDA may approve the medical drug, treatment, or device.