What is a Clinical Study?
Clinical studies test the safety and effectiveness of a new treatment or a new medical device. Some other words for clinical study are clinical trial, research, protocol, or investigation.
Why are Clinical Studies needed?
Physicians are always looking for better ways to treat diseases or conditions. Without clinical studies, the medicines and/or medical devices for treating diseases would not improve.
Who participates in Clinical Studies?
As a patient at Barnes-Jewish Hospital, cared for by Washington University Physicians, you may be asked to participate in a clinical study. Clinical studies depend on willing and informed participants. They can only happen when patients participate.
Why participate in a Clinical Study?
People volunteer to be in research studies for various reasons. Some do it to gain access to the latest medical care that is only available in a research study, because the new treatment being studied may improve their health. Others do it to contribute to society in general. Perhaps they have family or friends who are ill. Regardless of the motivation, the information gained from each participant may potentially improve the lives of millions. We hope you will consider learning more about opportunities to be in a clinical study.
What happens before a Clinical Study?
First, the physicians and research team involved in the study will explain the purpose and the process of the study. Then you are given an Informed Consent Form to read and consider carefully. Informed consent is a process of learning key facts about a clinical study before deciding whether or not to volunteer for the study. If you agree to participate, you sign the Informed Consent Form.
Are there benefits?
You may benefit from the new therapy or device which is being studied. But not everyone who is in a research study may benefit personally. Sometimes, your participation will benefit society by helping physicians to learn more about a certain disease or condition, or improvement the treatment of others.
Are there risks?
Possible risks of every clinical study are different. Most risks involve side effects or adverse reactions and are temporary. Every effort is made to minimize risks. But since the treatment or device is still being studied, it is impossible to know every possible side effect or adverse reaction. Before participating in a clinical study, participants are informed of the known risks and during the study they are monitored very closely to decrease the risks.
What protection do participants have in a Clinical Study?
The ethical and legal codes that govern medical practice also apply to clinical studies. In addition, clinical research is regulated by the US government, with built-in safeguards to protect participants. Washington University School of Medicine has its own Human Research Protection Office (HRPO). HRPO is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc.
Why do the Washington University School of Medicine physicians at Barnes-Jewish Hospital need your help?
More than 1,000 clinical studies begin every year to evaluate new therapies or devices. For every clinical study, investigators need patients to volunteer as research participants.
Can you volunteer for a Clinical Study even if not a patient at Barnes-Jewish Hospital?
Yes. Volunteer for Health is a program sponsored by Washington University School of Medicine to support patient-oriented research. It recruits non-patients for clinical studies. The first step to becoming a study volunteer is to be a member of the Volunteer for Health Research Participant Registry. The Registry gives individuals the opportunity to participate in clinical studies and play a vital role in improving health care. Go to vfh.wustl.edu for more information.
Points to Remember
- Clinical trials are tests of medical treatments or devices to see if they work and are safe.
- Before you agree to take part in a study, you must be given complete information about the study, including possible benefits and side effects.
- You should ask lots of questions to be sure you understand the study.
- You must sign a special agreement called the “Informed Consent” before taking part in the study.
- The Informed Consent is not a contract. You can leave the study at any time.
- Your participation is greatly needed and appreciated. You may help yourself and others to improve health and health care.
- We hope you will consider learning more about opportunities to be in a clinical study.