Participating in a clinical trial can be rewarding, but also may lead to many questions for potential volunteers. Our experienced medical and health professionals are available to answer any questions you may have before, during, or after your potential participation. We also encourage you to discuss trial participation with your primary care physician.
- What is a clinical trial?
Clinical trials are research studies conducted to evaluate the safety and effectiveness of a particular treatment, drug or device. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
- How does a clinical trial work?
In clinical trials, investigational drugs are often compared with approved drugs or placebo (inactive pill, liquid, or powder) to assess safety and effectiveness. Clinical study participants may be assigned to take:
- Investigational drugs
- Approved drugs
- A combination of these drugs
A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the investigational treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, the level of medical attention and care that each receives is the same.
- What do I need to know if I am thinking about participating?
There are certain requirements, or inclusion/exclusion criteria, that must be met to be eligible to participate in a clinical study. These requirements are based on such factors as age, gender, the type and stage of a disease, previous and current treatments, and other medical conditions. Medical insurance is not required to participate in clinical studies or to receive study-related medical care and services.
If you are eligible and decide to participate, an informed consent form will be presented to you. This form includes information about the clinical study and what you can expect as a participant, as well as potential benefits and possible risks associated with the research.
You should take your time and read carefully through the informed consent document. When you are satisfied that all of your questions have been answered, you will be asked to sign the document.
As a participant, you may be asked to:
- Take investigational drugs as directed
- Come in for your office visits
- Have laboratory and diagnostic tests
Study participants may also receive, at no cost, study-related medical care, investigational drugs, and laboratory services.
- What are potential benefits and risks associated with participation?
Clinical studies allow eligible participants to:
- Obtain study-related medical care at research facilities during a study
- Gain access to research treatments before they are widely available
- Help others by contributing to medical research
- Play an active role in your healthcare
There are risks to clinical research studies:
- There may be unpleasant, serious, or even life-threatening side effects to the study drug
- The experimental drug may not be effective for the participant
- Study participation may require more time and attention than would a routine treatment, including trips to the study site, more study tests and procedures, hospital stays, or complex dosage requirements
- How am I protected?
The path to finding out if a new drug is safe or effective is to test it on patient volunteers. By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits. (Source: www.nih.gov)
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