What is a clinical trial?

A clinical trial is a research study in which volunteers receive investigational medical products developed by pharmaceutical and biotechnology companies. Qualified physicians called Investigators, as well as other research professionals, are selected by the sponsoring companies to conduct these trials in order to determine the benefits of their investigational drugs.

Clinical trials are usually conducted in three phases—phase I, phase II and phase III. A small number of people participate in phase I trials while the later phases encompass a larger number of volunteers.

Who can participate in a clinical trial?

There are guidelines that determine who can participate. First, a volunteer must qualify for the study. Criteria permitting volunteers to participate in a clinical trial are called “inclusion criteria.” Factors that disallow volunteers from participating are called “exclusion criteria.” Age, gender, the type and stage of a disease, previous treatment history, and other medical conditions are examples of such criteria.

Second, some clinical trials seek participants with specific illnesses or conditions to be studied. Others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participant safety, and ensure that researchers learn the information they need.

How does a clinical trial work?

In a clinical trial, a volunteer is usually assigned to a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.

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 active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteer during the study. Regardless of which treatment is received, however, the level of medical attention and respect that each participant receives is the same.

Are clinical trials safe?

If you are a participant in a Phase 2 or 3 study, you may be receiving cutting edge treatments and most certainly will receive highly supervised safety monitoring of your medical condition throughout your participation in the study.  On the flip side, you may experience a worsening of your medical condition due to receiving the placebo control group, or if the study drug simply does not show efficacy.  If this occurs, it is the duty of the study doctor to determine whether you should be withdrawn from the trial, be put on a different treatment regimen, or continue with the study.  It is also the right of the study participant to make these decisions as well.  In either case, the medical attention that all study participants receive is far more thorough than is usually available in a non-research setting.  The physicians run more tests, spend more time with you, and discuss your condition much more extensively than you would likely otherwise experience.

What is an informed consent?

It is important to understand that you will sign an Informed Consent Form prior to your participation in any clinical trial.  The informed consent will highlight all the known risks, benefits, responsible parties, regulatory agencies, ethical review boards, and study staff involved in the study.  This Informed Consent Form might look like a contract, but in no way does it serve as a binding agreement between you and any entity associated with the study.  As a matter of fact, you could quit the study immediately after you sign the form.  It simply serves as documentation that all appropriate and relevant information was given to you and highlights some study contacts for you to reach out to should the need ever arise.  

Who is looking out for my safety?

Your study doctor and study staff are obligated to place your well being above any other study goals.  This means that if the study is causing you any harm that the doctor believes is unnecessary, they will withdraw you from the clinical trial and place you on the current standard of appropriate treatment.   

Is my personal health information confidential?

Yes.  We do not share your information with anyone outside of our study staff.  Even the study sponsor will never see any information about yourself such as social security numbers, medication or medical history, nor will your information be provided to any insurance company.  Furthermore your insurance will NOT be billed and you usually even receive compensation for your time and efforts.