Clinical trials and studies are sometimes used interchangeably but they are actually different subgroups of clinical research. A clinical trial is a part of a clinical study. Participants in studies and trials agree to participate under the scientists’ or doctors’ guidelines.
If you’re considering clinical research or participating in a clinical trial, it’s a good idea to know what you’re getting into. Let’s take a look at the different between clinical studies and clinical trials.
What is a Clinical Study?
Clinical studies assist researchers and clinicians in understanding medical conditions and treatments. Clinical trials and observational studies are the most popular forms of clinical studies. Both teach doctors and nurses about new pharmaceuticals, devices, surgical procedures, and therapies to treat or prevent patients’ ailments. They also develop diagnostic tools to detect and prevent diseases.
Who Conducts Clinical Studies?
Sponsors finance medical studies. Sponsors include university medical centers, pharmaceutical businesses, volunteers, and federal entities like the National Institutes of Health (NIH and the Department of Defense (DoD). Investors in clinical trials frequently seek new medical insights or possible remedies.
Who Leads a Clinical Study?
Doctors are the principal investigators or leaders of all research investigations. The lead investigator is the head of a research team and the team typically include professionals of varied skill levels like doctors, nurses, social workers, etc. The research is mainly done in hospitals, health facilities, or universities.
Can Anyone Participate in a Study?
The research team follows tight guidelines when setting study conditions. This assures success and that can determine who is allowed to participate in a study. Membership eligibility is based on predetermined criteria. Common factors include age, gender, ethnicity, presence of a certain disease, disease stage, and previous medical treatment.
Researchers occasionally randomly select people and ask them to participate if they meet particular requirements.
What’s a Clinical Trial?
Clinical trials are part of clinical studies. Participants must follow certain protocols and interventions of the clinical trial. Medicines, technologies, and behavioral changes are some of the interventions involved. Occasionally, a combination of intervention or protocols are used.
What Are Scientists Looking for in Clinical Trials?
Trials help doctors discover insights on new illness treatments and prevention methods. The study team meticulously records participant replies to study protocols. Clinical trials can:
- Compare current and old medical procedures
- Evaluate two well-established medical therapies and compare their results
- Compare the effects of a new drug to those obtained using a placebo to determine its effectiveness
How Do Trials Work?
The FDA has a four-step clinical trial approach to help researchers find effective dosages, identify potential side effects, and, ideally, secure FDA approval for widespread clinical use. Each phase must focus on safety and effectiveness. The phases are:
- Phase I clinical trials are small-scale experiments on healthy adults of diverse ages. This phase assesses the efficacy and side effects to determine the dose.
- Phase II clinical trials involve 100–300 patients and is used to assess if a pharmaceutical or medical device is safe and effective for treating an illness or symptom.
- Phase III clinical trials typically involve thousands of participants. Researchers analyze doses, populations, and other features. In Phase III, the FDA may approve an experimental drug or technology for widespread use.
- Phase IV clinical trials are the final step in drug or device development. During Phase IV, the efficacy and safety in larger representative groups is evaluated. Due to the delayed onset of side effects and other adverse responses, Phase IV patients receiving the new medication or treatment in a real-world settings are carefully watched.
How to Participate in Clinical Trials
Before you enroll in a clinical trial, consult your doctor. They may need to provide permission for you to participate. Your doctor’s office may enroll patients in a clinical study or refer you to another center if your doctor gives permission. You can also search for a trial or join a free service that alerts you to new clinical trials.
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