Participating in Clinical Trials - Crohns and Colitis Trials











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 and 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

    Demographic factors such as age and gender

  • Medications you are taking

    Medications you are taking

  • Results of medical tests

    Results of medical tests

  • Other health problems you may be experiencing

    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.