MID ATLANTIC RESEARCH CENTER FOR HEALTH

Bringing Medicine To The Market Place

About Clinical Trials

 


What is a clinical trial?
A clinical trial is a scientifically designed study that tests the effectiveness and/or safety of a new medical treatment, drug or device on a patient or patient population.  Years are dedicated to laboratory and animal research to determine the general use and safety of a new treatment.  A clinical trial is different in that it enables researchers and doctors to study and determine the exact effects of a particular treatment on actual people.

A clinical trial may help determine that the investigational treatment in question is better than, as effective as, or worse than other standard treatments for the same medical condition.  Or it may confirm the discovery of a successful treatment for a disease that has never had a previous treatment.

Most importantly, a clinical trial is a trusted partnership and commitment between doctor and volunteer patients.  It is the final test in a series of carefully controlled scientific studies that are conducted to improve the quality of life for future potential patients in a way that all those involved will never know.

Participating in a clinical trial means weighing possible benefits against possible risks.  You will always be free to change your mind and end your participation at any time.  However, it is important that you not join a study out of curiosity.  If even a few patients quit out of disinterest or for other reasons, there may not be enough patients left to achieve reliable or accurate results.  A clinical trial requires a commitment that should only be made after discussing all the facts with a trained health professional and assessing your personal reasons for participating.

Why are clinical trials necessary?
The human condition is the foremost concern of the medical world. Researchers and doctors are constantly looking for new, more efficient, and more accurate methods of treating illnesses and diseases.  However, their discoveries cannot be put into general use until testing is completed on actual patients.  Clinical trials are the only way that successful testing can be done.

The Food and Drug Administration (FDA) requires that clinical trials be conducted before it can approve a new treatment as safe and effective for public use.  Therefore, such trials and studies are the only link between research and relief of human suffering.

Who conducts clinical trials?
Sponsors for a clinical trial may include pharmaceutical companies, research institutions, or other health organizations.  The sponsor is responsible for funding and for designing the study's protocol.  This protocol is a detailed set of guidelines that investigators must follow in order to assure and confirm that the exact same clinical trial is being conducted at several different locations.

Although pharmaceutical companies or other health organizations may sponsor a clinical trial, only trained doctors, nurses, researchers and medical staff may actually conduct the trial.

What is a clinical trial like?
Participating in a clinical trial is similar to a regular visit to the hospital, medical clinic or doctor's office, but as a trial patient you will receive more personal attention.  Volunteers are the keys to the success of a trial, so all patients are treated professionally and with extreme care.

Who is eligible to participate in a clinical trial?
Each individual trial is an attempt to answer a very specific research question, therefore each trial has certain prerequisites and requirements concerning health, medication, age and other personal factors.  A participant must meet all requirements to be an eligible volunteer.  The researchers conducting the trial will be able to provide specific information as per that particular study.

Why participate in a clinical trial?
Participating in a trial will not only help you and possibly improve your health with a new treatment, it will help thousands of others who may have a similar problem.  New drugs or procedures may reduce pain and even cure your illness.

Participating in a clinical trial will give you the satisfaction that comes from being part of a scientific research study.  There are people hoping every day for a breakthrough treatment that will make coping with an illness easier, or that will possibly even eliminate it completely.  Trial volunteers help make such discoveries possible and available to people across the country and around the world.

Remember, deciding to participate or to continue participation in a trial is entirely up to you.

What is expected of me as a participant?
Your most important responsibility is to fully understand and comprehend the importance of your commitment to the trial.  The investigators and sponsors require promptness to all appointments as well as carefully followed instructions.  You must also be able to take all medication exactly as instructed.

Also, you need to take the trial seriously with full cooperation and participation so that the investigators can collect the information mandatory for a successful study.

What are the risks?
Risks will vary from trial to trial.  Unfortunately, no one is able to confirm with certainty the risks of any particular trial.  Researchers do expect certain results from a study, but the fact that the treatment is still under investigation makes it impossible to rule out any side effects or adverse reactions.

While it is possible that some side effects may be permanent or even life-threatening, most are temporary and will go away as soon as the treatment is completed.

What can I expect from the clinical trial team?
You have the right to expect complete and accurate information about the trial, so do not participate in any clinical trial unless your questions have been reasonably answered.

As a volunteer, you will receive a consent form to read and sign.  This process is required by law so that you understand what is involved in the trial.  The form should include an honest discussion of the potential risks and benefits of the trial.

You should also receive complete information about the schedule and duration of the trial, directions to the facility, and the name of someone you can contact with any questions or problems.

How am I protected as a trial volunteer?
As a patient under a doctor's supervision and care, the same laws and ethics that normally regulate the medical profession protect you.  Informed consent helps to protect you by making certain that you have been given all the necessary information about the trial.  The FDA regulates clinical trial advertisements in order to reduce misleading claims, and it also requires an institutional review board to review the general progress of the trial.