Are clinical trials safe?


Clinical trials are conducted according to a strict oversight by the Food and Drug Administration (FDA). The FDA sets the rules to make sure that people who agree to be in studies are treated safely.
All clinical research plans—known as “research protocols”—must go through a rigorous process to ensure that the research is not only scientifically sound, but also safe for study volunteers’ health and human rights. All research studies conducted in the U.S. must abide by the ethical principles found in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and other strict federal guidelines. Clinical trials also enlist the support of Institutional Review Boards (IRB) to protect participants’ safety. An IRB is an independent group made up of scientists, doctors and other people. IRBs play a critical role in protecting the interests of study volunteers by ensuring that any risks to their safety are minimized and study volunteers’ rights are fully protected.
While study volunteers’ safety is paramount, there may be risks, both known and unknown, associated with taking an experimental treatment. When considering participation, it’s critical to understand the known potential side effects and weigh these with any potential benefits. Moreover, as a study volunteer, its crucial to know what to do if a complication should arise.

IT COULDN'T BE DONE WITHOUT PEOPLE LIKE YOU!

If there are no volunteers for clinical trials, there will be no new medications on the market to treat disease. A decision to participate may not only bring you hope but also benefits public health and advances medical knowledge.

You are truly making a difference!


"Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
In the United States, an independent committee of physicians, statisticians, and members of the community must approve and monitor the protocol. They make sure that the risks are small and are worth the potential benefits."

                                                                                                                                                                                                               NIH: National Institutes of Health




What can volunteers expect if they choose to participate?


Participants receive a physical examination and their medical histories are reviewed by a research staff member once they are enrolled in the study. The volunteers’ health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information. 

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What is informed consent?



Informed consent means that the volunteer agrees to participate in the trial under conditions explained by the investigators. However, the volunteer is not legally bound to remain in the trial, and may leave at any time without penalty. It is hoped that volunteers will remain in the trial so that study results are not skewed by dropouts.
Informed consent will review infomation such as:
• The study's plan
• Treatment to be given during the trial
• Tests that will be carried out
• Follow-up procedures after the trial
Once signed, all Mountain View Clinical Research volunteers will be given a copy of their Informed Consent.


What is a Clinical Trial ?


Why should I participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. It is no exaggeration to say that a large share of the credit for current treatment successes belongs to the people who participated in the clinical trials conducted over the last decade.