Clinical trials are an important key to research – and YOU can be a part of it!

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Because Breakthrough T1D has been able to successfully accelerate research discoveries, Breakthrough T1D is currently funding over 70 clinical trials, nationwide. A clinical trial is the most important, last step before a new treatment or new device can apply for FDA approval and become available to the public. Currently, clinical trials on prevention, new treatments and cures are delayed when we do not have enough people to participate in trials.

There are many reasons to consider participating in a clinical trial

  • It is through clinical trials that new drugs, therapies and ultimately, a cure for T1D will be discovered.
  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • Devices and new medications that are part of the trial are covered – access to pumps and CGM’s you normally don’t have
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • YOU KEEP YOUR DOCTOR
  • You can stop participating at any time if new concerns arise or you lose your confidence that the potential benefit outweighs the risk.

Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device or biologic. Clinical trials are conducted only after health and ethics committees have given their approval for the trial. Each trial has a certain number of participants that are required. This number is important for the validity and efficacy of the trial.

Treatments having acceptable safety profiles and showing promise are then considered for a phase 2 or 3 clinical trial. The initial phase 1 trial is the initial safety trial involving a small number of participants (20-100). It is not uncommon in a trial that the treatment being used is also being used for another disease. This means the drug may have a lengthy safety track record of many years. Inquiring about a clinical trial, gives the study staff at the research institution the opportunity to explain all facets of the trial and for you to ask questions.

Those who have participated in a clinical trial are often likely to participate in additional trials when their current trial is finished. In a 2017 survey, 91 percent of clinical trial participants surveyed said they would “definitely” or “probably” recommend clinical trial participation to a friend or a family member.

Locally, Debbie Evans is the Clinical Trial Education Volunteer for the Breakthrough T1D Minnesota and Dakotas chapter. If you need help with the Connection Tool or have other questions about clinical studies in general, Debbie would be glad to help or answer your questions. As you look at descriptions of trials in your area, the contact person for that trial can best answer specific detailed questions. Debbie can be reached at debbieaevans1@gmail.com or 612-810-1833.