Health

What You Need to Know About Clinical Trials

Clinical trials are a type of research study with the objective of evaluating the medical, behavioral, or surgical effects on a person. They’re vital in helping researchers discover how a new drug or medical aide works within a subject, and whether it’s deemed safe enough to potentially go into mass production.

A clinical trial may help decide what treatment is most effective for a group of people with an existing medical condition or monitor the severity of its potential side effects. The focus of these clinical trials is usually to find a way to make someone’s quality of life better.

Based on clinical outcome assessments, these clinical trial results could ultimately make a significant change in someone’s life.

Clinical trials are implemented in four phases.

  • A phase 1 clinical trial will test out the effects of a treatment on a group of regular, healthy people in order to gauge its safety and side effects.
  • A phase 2 clinical trial broadens the number of test subjects and focuses more on the potency and validity of the drug, and if the drug is effective in people with a health condition. Safety and short-term side effects are closely analyzed, and this phase can continue for several years.
  • A phase three clinical trial compiles even more information regarding safety and effectiveness, along with studying different dosage volumes and how they combine with other drugs. At this point, the number of trial subjects can reach up to 3,000 people. If the FDA concurs with the trial’s positive results, it will then approve the experimental medication or device.
  • The final phase four of a clinical trial only happens after the FDA has approved it. The drug or medical device is then monitored in a much larger and more diverse population.

What if I find a clinical trial that I want to be a part of?

Be sure to let your doctor know that you’re considering participating in a clinical trial, just in case they want to discuss anything with the research team. After that, you can contact the trial coordinators, usually located in the contact information on any study advertisements.

You’ll go through a screening process to see if you meet their trial requirements and you’ll be able to ask questions about the study.

If you’re both happy to move forward from there, you’ll sign a consent form, and if accepted, you’ll schedule a visit for researchers to conduct some cognitive and physical tests on you.

You’ll then be assigned to a specific treatment group to begin the trial and communicate with the research team. You’ll most likely return to the research site regularly to be evaluated, and will continue to see your regular health care professionals throughout the study.

Important questions to ask before doing a clinical trial

The following questions will help you to develop a better understanding of the study and what is expected of you:

  • What is the objective of the study?
  • What are the possible side effects?
  • How long will the clinical trial last?
  • Am I reimbursed for any costs I incur during the trial?
  • Do you continue to check up on my health after the trial?

If you’re considering being a participant in a clinical trial, there are always trials available for people curious about joining, for whatever the reason may be.

One of the most important aspects of a successful clinical trial is diversity, so no matter what your age, sex, race, or gender, there’s a research team out there somewhere eager to enlist your services.

About the author

Editorial Staff

Add Comment

Click here to post a comment