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Clinical Trials / Parkinson's Disease
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Well-designed clinical trials are essential to developing new treatments and possible cures.  Participation in a clinical trial is a selfless act that may help many other people in the future.  It's research, not therapy.  
 
Experiments in test tubes and mice may show great potential, but what works in the laboratory doesn't necessarily translate to humans.  We have to test new approaches, drugs, biologics (such as vaccines) or procedures with people to show what really works and that's the role of the clinical trial.

There are many types of clinical trials including studies to prevent, delay, detect, and cure disease, manage symptoms and improve quality of life.  The U.S. Food and Drug Administration (FDA) requires trials to be successfully completed before a new product can be brought to market.

Clinical trials are done in phases, with each phase designed to answer specific questions about the safety, tolerability, and effectiveness of the potential treatment.

  • Phase 0 is a recent designation for an exploratory trial to establish very early on whether an agent behaves in human subjects as was anticipated from preclinical studies.
  • Phase I tests for safety. It involves relatively few patients.
  • Phase II tests a larger group of people, and researchers begin to look for signs of effectiveness.
  • Phase III tests even larger groups of people to confirm effectiveness, monitor side effects, and make comparisons to existing treatments.
  • Phase IV occurs after the treatment has been approved to oversee its effect on various populations and determine the consequences of long-term use.

Enrollment in clinical trials is always voluntary.  Choosing whether or not to take part in a one is an important personal decision.  To make a choice that's right for you, you need to understand the differences between medical therapy and a clinical trial. 

Medical Therapy

Clinical Trial

Is undertaken to treat a patient and improve his or her health  Is undertaken to gain knowledge so that treatment can be improved for future patients
Can be adjusted to meet the needs of the patient  Follows a strict protocol
Has been deemed safe by clinical testing in the past  May involve a degree of risk despite safeguards designed into the protocol
Has a history that can be used to predict potential side effects and outcomes   Has a limited history from earlier trials that may be useful for Phase III participants

You also need to understand there are no guarantees in clinical trials.  A new treatment is not always better, and can sometimes be worse than existing treatments.  Plus, some participants may not receive the experimental treatment.  Typically, trial subjects are randomly divided into groups. One group receives the treatment and the other does not.  The people in the latter group may receive the standard treatment or a placebo.

All that being said, there are many reasons to participate in a clinical trial. 

  • Clinical trials are an essential and necessary component of the scientific research process.  New and better treatments will come only if people volunteer for trials.   People who participated in the past are responsible for the treatments everyone enjoys today.
  • Participating in a clinical trial can be a satisfying and worthwhile experience. People can feel good about contributing to the advancement of medical knowledge and helping others in the future. 
  • If all approved treatment options have failed, or none exist, the possibility of gaining access to an advantageous alternative may be enough.  While researchers cannot guarantee outcomes, patients who participate in clinical trials sometimes have higher survival rates than patients who receive standard treatment.
  • Patients in clinical trials receive very close monitoring by medical professionals who are leaders in their fields.

In the case of Parkinson's disease, we're on the brink of many exciting new treatments including new methods to deliver dopamine to critical areas in the brain, protecting nerve cells from premature death, and replacing dead nerve cells with transplanted tissue.

However, to move these and other promising concepts from the research stage into the hands of patients who need them, more people with Parkinson's need to take part in clinical trials.  According to the Parkinson's Disease Foundation, the approximately 5,000 people with Parkinson's who participate in clinical research today is far short of the 10,000 to 15,000 who will be needed to conduct clinical studies over the next two to three years. This disparity could result in severe delays in the availability of new treatments.

 
Learn more about Clinical Trials / Parkinson's Disease:
 
Key Point 3: There are ethical considerations in all clinical trials, and participation can have personal and societal benefits. It is important that research be done ethically at all times.
 

Conduct an off-site search for Clinical Trials / Parkinson's Disease information from MedlinePlus.  These up-to-date search results are based on search terms specific to Second Opinion Key Points.
 
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