Home > Pancreas Education > Clinical Trials

Treatment of Pancreatic Cancer: Clinical Trials

Clinical trials are the bridge over which all new medical therapies must pass to become accepted practice - and the bridge is a long one. For patients, clinical trials can typically last for a few weeks or months. For scientists, they can continue on for years before a new therapy may see the light of day.

There are different types of clinical trials: treatment, prevention, diagnostic, screening, and quality of life trials-and the trials are conducted in progressive phases (I-IV). Once a clinical trial reaches the end of the bridge-proving its potential worth as a medical therapy-the Food and Drug Administration (FDA), a government agency, must officially approve the therapy for medical consumers.

To ensure that no one can influence the results of a study, clinical trials employ a range of specialized testing mechanisms intended to prevent bias and provide reliable results:

• Prospective Trials—Patients are identified and then followed over time.
• Randomized Trials—Patients are grouped by chance into (typically) a treatment group and a control group (also called a placebo group). A control group receives either the current standard treatment or a placebo-an inactive pill or liquid. The results of the control group are then compared with those of the treatment group.
• Cross-over Trials—Patients receive both the treatment and the placebo at different times, with careful monitoring of their responses to both approaches.
• Double-blinded Trials—Neither the patient nor the researcher knows if the patient is receiving the treatment or the placebo.

In addition, some clinical trials are called open label studies, because both the patient and the researcher know that the patient is receiving the treatment and not the placebo.

By federal regulation, every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, community advocates, and others. The IRB is charged with ensuring that all clinical trials within a given medical institution are ethical and that the rights of the participants in those trials are protected.

Clinical trials retain very specific participation guidelines. Establishing and maintaining these guidelines is a critical part of producing meaningful and reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria," while those that disallow someone are called "exclusion criteria." Typical criteria include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

If you are interested in learning about the clinical trials currently offered at The Pancreas Center, click here.