Clinical Trials

What are Clinical Trials?
Clinical trials (also known as clinical research) are research studies in human volunteers that investigate treatments and observe patient performance with new treatments.  They play an important role in developing new treatment options for a variety of diseases.

Before any new treatment can be tested in humans, it must have shown positive results in the laboratory and/or in animal studies.  Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

The United States Food and Drug Administration (FDA) monitors most clinical trials to protect the participants and the general public.  Ultimately, the FDA reviews and analyzes data from successful clinical trials to determine whether the experimental treatment should be approved for the treatment of a specific disease or disorder.

Clinical trials may be carried out using completely new treatment options or using treatments that are already available.  Clinical trials are the safest and quickest way to confirm whether new treatments are truly beneficial for patients.

Why are clinical trials important?
Clinical trials offer a look at future treatments. They determine whether a new and potentially better treatment is safe and effective in humans.  Clinical trials may provide opportunities for you to receive a promising drug or treatment.  Typically currently approved therapies are compared with new therapies and your doctor may feel this is an appropriate treatment for you.

Things you should know before participating in a clinical trial

Talk to your doctor

You should always discuss the benefits and risks of participating in clinical trials with your doctor.

Eligibility

Each clinical trial will have its own set of eligibility requirements.  Your doctor will be able to help assess your eligibility for a specific trial.

Informed Consent

The FDA requires that an individual read and sign an informed consent form before being enrolled in a clinical trial.  Informed consent is a process that ensures patients are given complete information about a clinical trial prior to their participation.  The key facts of the study are included in a written informed consent form for participants to read and discuss with their families and doctors.  Be sure you understand all the facts before you sign the consent form.  Don’t be afraid to ask questions!

Benefits and Risks of Clinical Trials

  • Potential Benefits:
    • There is the possibility that drugs or treatment program used in the trial will be better than currently approved treatment options
    • Patient care is provided by top doctors and researchers at leading health care facilities
    • You will have access to new treatment strategies that may not otherwise be available
    • Your progress will be closely monitored
    • Your participation may help to advance treatment of the disease
  • Potential Risks:
    • There is the possibility of unknown or unexpected side effects
    • There is always the chance that the new drug or treatment may be ineffective or less effective than current options
    • Participation in the clinical trial may require greater time commitment for treatment due to extra clinic visits for treatments or monitoring
    • You need to factor in the potential of additional costs that may be involved, such as housing and transportation, insurance payment for treatment outside covered network, etc.

Where can you find information about current clinical trials?

Clinicaltrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details.

You can use this site to find a wealth of information about clinical research, including listings of active industry and government-sponsored clinical trials, as well as new drug therapies in research and those recently approved by the FDA. Our site is designed to be an open resource for patients interested in participating in clinical trials and for research professionals.

Pharmaceutical companies also conduct clinical trials.

Here is a list of some clinical trials being conducted by pharmaceutical companies:

  • GlobeImmune
    • Clinical Trials.Gov Identifier: NCT00300950*
  • Tragara
    • Clinical Trials. Gov Identifier: NCT00709826
  • New Link *NEW*
    • Clinical Trials.Gov Identifier:  NCT01072981

    • *To access these trials through Clinical Trials.Gov visit www.clinicaltrials.gov and enter the identifier number in the search bar on the upper right.

    The National Pancreas Foundation does not endorse ANY specific clinical trial.  Participating in a clinical trial is an important decision, and you should work with your doctors and healthcare teams to determine whether taking part in a clinical trial is right for YOU.

Legal Disclaimer

The National Pancreas Foundation does not endorse ANY specific clinical trial. Participating in a clinical trial is an important decision, and you should work with your doctors and healthcare teams to determine whether taking part in a clinical trial is right for YOU.