Clinical research is a cornerstone of our health care system. Through clinical trials, experts are able to advance medical knowledge, enhance patient care, and discover innovative treatments for disease. The United States is known for its high standards of medical care, and for this patients can thank the meticulous use of clinical research under the guidance of the FDA.
What is a Clinical Trial?
A clinical trial is a specific type of medical research. Unlike observational studies, which observe and monitor patients receiving routine care, clinical trials study specific drugs or medical devices using randomized groups of participants. All participants must qualify for a clinical trial based on certain factors ranging from genetics and use of drugs to manifestations of a specific disease.
Overall, a clinical trial seeks to determine the safety, efficacy, and dosing of a drug. Participants are split into groups randomly selected to receive either a placebo, the current standard of care, or the drug being studied.
All clinical research is completed in four distinct phases, all of which must be approved by the FDA:
- Phase I: 20-100 participants
- Phase II: 200 participants
- Phase III: Thousands of patients, usually internationally
- Phase IV: Ongoing evaluation of patients with focus on side effects
Physicians, nurses, social workers, pharmacists, and other health care professionals make up clinical research teams that collaborate to complete clinical trials. Funding may be provided by pharmaceutical companies, foundations, health care providers, philanthropists, or the federal government.
Clinical Research Brings New Treatments to Market
Some countries make medical treatments available without stringent oversight, but the U.S isn’t one of them. In America, clinical research ensures that new treatments are thoroughly studied, assessed, and reviewed before hitting the public market.
The ability to perform clinical research hinges on the willingness of healthy and ill volunteers alike. Since the conception of the National Institutes of Health (NIH) and FDA, these volunteers have made groundbreaking scientific advances possible by participating in clinical trials.
Even when clinical research fails to achieve predicted outcomes, doctors still obtain valuable information that can be applied to future trials and point scientists in the right direction on new endeavors.
Clinical Research Tests Safety and Efficacy
Through the four stages of clinical research, every new treatment undergoes comprehensive evaluation. This allows doctors and other health care professionals to determine if a treatment works, if it works better than existing treatments, and what side effects it may cause.
Until clinical research is performed, there’s no way to establish if a treatment is safe and effective for human use.
Clinical Research Empowers Patients
Well-designed clinical trials give patients the opportunity to play an active role in their own health care. This is especially true for patients with chronic diseases that lack any current treatment or cure. By volunteering to participate in clinical trials, patients may gain access to new research treatments before they’re widely available and contribute to the advancement of medical potential.
In fact, surveys show that more than 60% of Americans are willing to participate in clinical research studies. That percentage rises above 80% when the clinical research focuses on noncurable or fatal diseases like cancer, addiction, depression, and heart disease.
Overall, clinical research is the backbone of biomedical research. It brings ideas and laboratory data to life, evaluates unbiased results, and influences future medical treatments accordingly.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/ https://www.ncbi.nlm.nih.gov/books/NBK9571/