What is Clinical Trials and Studies?
Have you ever wondered about the process that is used to bring Tylenol to market? This process is called Clinical research. Clinical research is medical research involving people. There are two types, observational studies, and clinical trials.Observational Studies
Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. These studies may help identify new possibilities for clinical trials.Clinical Trials
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.
Before the U.S Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
Before the U.S Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
Before You Participate
PRS invites you to volunteer as a participant in any of our various clinical studies. We encourage you to visit clinicaltrial.gov to learn more about clinical research so that you will be informed.
Patients
Many people do not respond well to current therapies, therefore there is a medical need for more effective treatments. If you suffer with moderate or severe symptoms, we would like to invite you to learn more about clinical trials. If you decide to participate in clinical research, here is a brief synopsis of the process:What is the trial participation process?
1. Pre-Screening
Initial conversation by phone or in the clinic with a member of the study team to tell you about the study opportunity
2. Informed Consent
Review forms that explain your rights and obligations as a participant
3. Screening
The study team will determine if you meet the basic study requirements
4. Enrollment/Randomisation
You will be assigned to a treatment course, which may be a placebo
5. Study Visits
These may be days, weeks, or months, apart. The study team will let you know what to expect each visit
6. Follow-up Period
Assesses how you are doing after ending study treatment through appointments or phone calls
7. Completion
Your participation in the study has ended
