Crohns And Colitis Trials » Participating in Clinical Trials

What Are Clinical Trials?

The main purpose of a clinical trial is to determine if a drug (or a procedure) is a safe and effective treatment for a medical condition, such as Crohn’s disease or ulcerative colitis.

All clinical trials must follow strict standards of regulatory authorities regarding data collection, treatment, and safety.

How Are Clinical Trials Conducted?

Patients who qualify for a clinical trial are enrolled in the study at a local hospital, research center or clinic.
Study administrators, on-site doctors or principal investigators provide study-related care for each patient during the course of the study.
During the study, some participants may receive investigational drugs, while others may receive a placebo, and others may receive prescribed drugs. Placebos are substances that do not have any medical effects (usually a sugar pill). Study administrators use drug(s) versus placebo measurement in their study data collection.

Joining a Clinical Trial

Not every clinical trial is a “fit” for every patient. All clinical trials have eligibility criteria—a set of rules that doctors and researchers are required to follow as they determine who can participate in a trial. Typical eligibility criteria includes:

Demographic factors such as age and gender
Medications you are taking

Results of medical tests
Other health problems you may be experiencing

Deciding to Join a Clinical Trial

Before deciding to participate in any clinical trial, you should carefully weigh the potential benefits against the risks.

Potential Benefits:

Participants who choose to enroll in a clinical trial help others by contributing to the advancement of medical care.
Those that enroll in a clinical trial may receive access to investigational drugs.
If a drug proves to be effective in a clinical trial, some patients may benefit from the effect of investigational drugs or procedures.
The trial sponsor may reimburse some or all of the costs associated with your medical care and transportation to/from study locations.

Risks:

Unanticipated side effects may occur. These side effects may be worse than those associated with standard/traditional treatments.
Because many clinical trials use placebos (typically a sugar pill) on a portion of the study population, there is no guarantee that you’ll receive the new treatment.
New treatments do not always turn out to be an improvement over standard treatments.
As with any standard drug or procedure, clinical trial treatments may not be effective for you even if they work for other patients.

Clinical Trial Phases

Clinical Trials are carefully staged in phases, each of which is designed to address specific research questions. If you are considering participating in a clinical trial, understanding what phase that trial is in can be an important factor.

Phase 1

Typically 15-30 Patients

Phase I trials test to see if a medication or procedure is safe. Phase 1 trials also attempt to evaluate the best way to administer treatment, and define any potential side effects. Researchers also look for signs that the disease is responding to the treatment being tested.

Phase 2

Typically Fewer Than 100 Patients

The drug or procedure is administered to a larger group of people to continue to test its efficacy and further evaluate safety.

Phase 3

Hundreds to Thousands of Patients

During this phase, the drug or procedure is administered a much larger group of patients. One of the goals of Phase 3 Clinical Trials is to determine whether the trial treatment is more effective than existing/traditional drugs or procedures.

Phase 4

Study Populations Vary

Phase 4 Clinical Trials examine a drug or medication after it has received FDA-approval and is on the market. The primary goal in this phase is to monitor longer-term benefits and side-effects.

Participating in Clinical Trials