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Clinical Trial Rundown

By Jennifer Bradley, Staff Writer

(Page 1 of 3)  
 

Every caregiver hopes for a miracle for their loved one with Parkinson’s disease. The promise of new drugs or therapies making a difference is exciting.  A caregiver may encourage their loved one to take the jump and become part of a clinical trial, in hopes of seeing a positive outcome. The decision, however, is ultimately left to the person living with the disease. A caregiver can learn the facts, discuss options and weigh the pros and cons, being a source of information and support. Finding the study is the easy part; thousands are conducted every year. The decision of whether to participate or not is more complicated.

What is a Clinical Trial?

Clinical trials are carefully designed research studies that evaluate new treatments for diseases. The purpose of a trial is to test the safety and results of medications or treatments not yet available to the general public. They are regulated by the Food and Drug Administration (FDA) and overseen by science and medical experts, who ensure the trials are safe and designed appropriately.

There are phases to a study, so each medication or treatment is not evaluated just once and then considered safe for use.

  • Phase I is a study typically done on 20-80 healthy people, to establish how the medication, for example, metabolizes and the reactions of different dosages.

  • Phase II trials further define the safety of the therapies and are usually conducted on a larger amount of participants, 100-300 people.

  • Phase III is where a current patient will be introduced into the study. These are longer, more involved trials, with even larger populations of participants (1,000-3,000). Many of these are known as “double-blind” studies, and determine the actual benefit of the treatment to the patient and whether the benefits outweigh the risks.

Finally, if the treatment is successful in all previous mentioned phases, it is up for approval from the FDA. Phase IV trials test the effect of different dosages in patients and give a good look at long-term effects.

Consent

Federal guidelines state that each participant in a clinical trial must be given very in-depth information about the trial before agreeing to participate. Legally, this is known as “informed consent.” The study’s staff will tell a caregiver and loved one about the purpose and length of the study, benefits and risks, confidentiality and more.  It’s a long process, completing the informed consent, but trial administrators need to ensure each participant is doing so voluntarily, with complete awareness of what to expect.  Both caregiver and loved one should know that informed consent is NOT a contract and the person can withdraw from the study at any time.

 

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