World Patient Safety Day takes place on September 17th. The focus is to promote global actions to enhance patient safety and reduce patient harm. It is also the perfect opportunity for educating our communities about the importance of clinical trials and the measures taken to ensure patient safety. In turn, individuals can gain the necessary information to participate in clinical trials with confidence.
Clinical Trial Summary
Clinical trials are performed to evaluate therapeutic, surgical, or behavioral interventions. They are the primary way that researchers find out if a new therapeutic approach, medical device, or investigational medication is safe and effective in people. Clinical trials also compare new treatments to standard ones to establish if they are safer and more effective than the standard options.
Other clinical trials focus on disease detection, prevention, or increasing our knowledge of the conditions through strategic observations.
Clinical Trial Patient Protections
Researchers are required to follow strict rules to make sure that participants are safe. The Federal Government enforces these rules. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The close monitoring of the patient’s safety, health, and rights is under the responsibilities of:
- An Institutional Review Board, or IRB
- The IRB is comprised of doctors, scientists, and support staff dedicated to making sure that the risks to study participants are as low as possible. The people on the IRB regularly review the study and its results.
- The Informed Consent Process
- Informed consent involves providing all the information necessary for making an informed decision before joining a trial. A trained research team member discusses an Informed Consent Form, or ICF, with potential study participants before enrolling in a clinical trial. The ICF reviews what to expect as a participant, the study medication or device and all the procedures that might happen during a trial. This includes information about any possible benefits and risks of the treatment. Participants also have a chance to ask questions about the trial. Informed Consent Forms are written and reviewed by the IRB to ensure they are accurate, realistic and easy to understand.
It’s important to know that the form you sign during the consent process does not obligate you to complete the study. Your participation in a trial is 100% voluntary, meaning you can withdraw your participation at any time.
Honoring World Patient Safety Day
We can all agree that ensuring ourselves and the ones we love are safe is something we encounter daily amid a pandemic. During the continuing challenges of COVID-19, a combination of virtual and other activities is taking place in observance of World Patient Safety Day. Join the global campaign by visiting https://patient-safety-day.org/
You Can Help Advance the Future of Health Care for Women.
Improving the availability of safe, effective treatment options for the countless medical conditions in existence is another vital piece in protecting patients. For women’s health care, many treatments are still based on male-dominated clinical research data. As a result, women have become more susceptible to adverse effects from a number of these therapies.
Seattle Clinical Research Center conducts clinical trials specializing in women’s health needs. Our research involves:
- Healthy women observational studies
- Preventative care
- Treatment of disorders with investigational or established interventions
Being a research volunteer gives women a unique opportunity to improve how to maintain good health and treat disorders. Call us at (206) 522-3330 or visit our website today to learn about participating in research and the studies we are currently recruiting for.
Sources:
https://patient-safety-day.org/
https://www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety
https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs
