A clinical trial is a scientific study that tests the effectiveness of a medical treatment, drug, or device with patients. While years are spent in laboratory and animal research to determine the general use and safety of a treatment, a clinical trial studies the exact effect of it on people.

A clinical trial may show that the investigational treatment is better than, as good as, or no better than the standard treatment for the same condition. Or it may confirm the discovery of a successful treatment of a disease for which there never had been a treatment at all.

A clinical trial is a partnership and a commitment between doctors and volunteer patients. It is the final test in a series of many carefully controlled scientific studies that are done to improve the quality of life.

Questions and Answers:

Should I Volunteer?

Why are clinical trials needed?

Who conducts clinical trials?

Who is eligible to be in a clinical trial?

What is a clinical trial like?

What are the risks?

What is needed of me?

What can I expect from the clinical trial team?

How am I protected as a clinical trial patient?

More questions

Glossory



Should I Volunteer ?

Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and the development of new therapies. Volunteers are important to the clinical study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications for a broad range of health problems. Each year, thousands of people volunteer to participate in clinical drug studies. Benefits to you as a volunteer may include:

• Participating in the research process that may lead to new therapies
• Receiving medical care from physicians during the study
• Learning new information about your condition, as well as meeting people with similar conditions
  

Why are clinical trials needed?
The medical world cares about the human condition. That’s why researchers constantly look for better or new ways of treating
illness and disease. But their discoveries can not be put into general use until controlled testing has been done on actual patients.

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

Who conducts clinical trials?
Pharmaceutical companies, research institutions, and other health organizations may be the sponsor of a clinical trial. They are responsible for funding and or designing its protocol. A protocol is a set of detailed guidelines that clinical investigators must follow in order to conduct the same trial at several different locations.

Although pharmaceutical companies sponsor a clinical trial, only trained doctors, nurses, and medical researchers actually conduct the trial itself.

Remember: Deciding whether or not to participate, or continue to participate, in a clinical trial is entirely up to you.

Who is eligible to be in a clinical trial?
Every clinical trial attempts to answer some very specific research questions. To do this, each trial has certain requirements about your health, medication, age, and other things. You must meet the requirements of a particular trial to be an eligible volunteer. Call SCR for information on requirements specific trials.

What is a clinical trial like?
Participating in a clinical trial is much like a regular visit to a hospital, medical clinic, or doctor’s office, but with even greater personal attention. The success of any trial depends on its volunteers. Patients are treated professionally and with care.

What are the risks?
Risks vary from trial to trial. Unfortunately, no one can say with certainty what the risks of a particular trial might be. Although researchers expect certain results from each trial, the fact that a treatment is still being studied makes it impossible to rule out side effects or adverse reactions. While it is possible that some side effects could be
permanent or life-threatening, most are temporary and will go away as soon as treatment is stopped.

What is needed of me?
Your first responsibility is to fully understand your commitment to the trial. The trial investigators and sponsor need you to be at your appointments on time, to follow their instructions carefully, and especially to take any medication exactly as told. They need you to take the trial seriously. Your full cooperation and participation is needed if the investigators are to collect the information they must have for a successful study.

What can I expect from the clinical trial team?
More than anything else, you have the right to expect complete information about the trial. Don’t participate in any clinical trial unless your questions have been reasonably answered. You will be given an informed consent form to read and sign. This is required by law to make sure you understand what is involved in a trial. It should include
honest discussion of potential risks and benefits. You should also expect complete information about the schedule and duration of the trial, directions to the trial location, and the name of someone you can contact with questions or problems.

How am I protected as a clinical trial patient?
As a patient under a doctor’s supervision, you are protected by the same laws and ethics normally regulated by the medical profession. Informed consent helps protect you by making sure you have been given all the necessary information about the trial. Clinical trial advertisements are regulated to reduce misleading claims. Regulations also require an institutional review board to review the general progress of the trial.

More questions:
What to ask your study doctor or nurse before participating
in a clinical trial:

What is the purpose of the trial?
What treatments will be done and how?
How is patient safety going to be checked?
What are the possible side effects and risks of this treatment?
How could this treatment benefit me?
Other than the one being tested, what treatments are available for the same condition?
How will the trial affect my daily life?
How long will the trial last?
Where is the trial being done?
Who is sponsoring the trial?
Will I have to pay anything?
What happens if I am harmed by the trial?
Will I be able to stay on the treatment when the trial is over?

Think it over carefully!
Deciding to participate in a clinical trial means weighing possible benefits against possible risks. You will always be free to change your mind and stop participating in a trial at any time. However, you are urged not to join a clinical trial out of curiosity. When even a few patients quit out of disinterest or for other reasons stop participating
mid-trial, they may not be enough patients left to achieve reliable results. It’s a commitment that should only be made after carefully discussing all the facts with your doctor or nurse and thinking about your own reasons for participating.

Glossary

Clinical trial: A scientific study that tests the effectiveness of a new medical treatment, drug, or device with patients.

Clinical investigator: A medical researcher in charge of carrying out a clinical trial’s protocol. This could be a doctor, nurse, pharmacist, or other health care professional.

Food and Drug Administration (FDA): The government agency that sets the guidelines on manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.

Informed consent: The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical trial
between clinical investigator and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial.

Institutional review board: A group of health care professionals from the institution where the clinical trial takes place, as well as members of the local community. The board makes sure all FDA and protocol regulations are followed and reviews all trial activities including recruitment and advertising, and potential risks. Investigational treatment: The drug or device being tested during a clinical trial.

Pharmaceutical company: A business that researches, develops, tests, manufactures, and/or sells medical drugs or devices.

Protocol: A detailed plan carefully designed by a clinical trial sponsor. It sets guidelines for a trial and usually involves several different trial locations.

Sponsor: The pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs its protocol.

Standard treatment: A treatment currently in wide use and approved for a particular disease or illness. In some trials involving investigational treatments, there may be no pre-existing treatment at all. In these cases, the lack of treatment is itself considered standard treatment. Generally, the investigational treatment is hoped to be safer or more
effective than the standard treatment.