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clinical trials

Participating in a Clinical Trial

Human clinical trials are the final phase of research done before a new drug or treatment is approved for the market. Many tests are conducted before the clinical trial stage to determine whether new treatments are both safe and effective for people. Participating in a clinical trial is one way you can play an important role in the fight to treat and cure type 1 diabetes. The decision to participate, however, is very personal and should be made only after speaking with your health care provider and other individuals you trust.

When you search for clinical trials on JDRF.org, you will be forwarded to ClinicalTrials.gov for the specific details of the trial.  More information about what ClinicalTrials.gov is, and how to use it, is below:

FAQs About ClinicalTrials.gov

  1. What is ClinicalTrials.gov?
  2. Why is JDRF directing me to ClinicalTrials.gov?
  3. How do I find clinical trials?
  4. If I don't have new onset type 1 diabetes, what are some ways to search for trials?
  5. How do I find out if I could be in a trial?
  6. How can I find out what clinical trials JDRF is funding or involved with?
  7. If JDRF is funding or involved in a trial, does this imply an endorsement of the trial by JDRF?

Types of Clinical Trials
Clinical trials can be divided into two main groups-observational and interventional. Observational trials are designed to gather information about a disease with the goal of publishing the findings in a scientific or academic journal, but do not directly result in products or therapies for people with the disease.  Interventional trials are designed to test drugs or therapies, and can be further divided into clinical research trials and clinical development trials. 

Clinical research trials generally test the effects of a drug or therapy that has shown potential to treat a disease or its symptoms, but most likely will not be brought to market in its current formulation. This research is meant to help scientists fine-tune their product in order to eventually bring the safest, most effective therapy possible to the market.

Clinical development trials test the effects of a drug or therapy that has a strong potential for being approved by the FDA. Assuming the results of the study are good, scientists then take further steps to get the drug approved for sale on the market.

Questions to Ask Your Doctor Before Joining a Clinical Trial
Once you have narrowed down your choices and found a trial you think you'd like to participate in, print out the details you have for the trial and set up a meeting with your doctor. Ask the following questions, in addition to any others you may have before applying and meeting with the trial's clinical investigator.

  • Do you foresee any reason why this trial may not be the right fit for me?
  • What are the risks and benefits of my participating in this trial?
  • How will this trial affect my daily life and treatment regimen?
    Do you have any reservations about collaborating with the trial investigators for my care during the trial?
  • Have you ever had a patient participate in a clinical trial while under your care? If so, have you learned anything I should know about before participating?
  • What questions would you like me to ask the clinical investigator before making my final decision?

Questions to Ask the Clinical Investigator Before Participating in a Trial
It is important to plan ahead and write down your questions before meeting with the research coordinator on a particular trial.  You may also want to bring a friend or relative, as well as a tape recorder, to help you understand and remember the details as you make your decision.  Some questions you may want to ask include:

  • What is the purpose of the study? 
  • Why do you believe the treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and treatments are involved in the study?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will I need to be hospitalized?
  • Who pays for the experimental treatment?  Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know if the treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?