Clinical Trials 101

Mary Anne Haggerty, RN, tests Randy Vinecore's response time

by Pamela Andrews

It is not uncommon to read an article or hear a news report saying, "A new study has shown...," for example, that butter is healthier than margarine or that you should drink eight glasses of water each day. Sometimes the results of one study seem to contradict another, or there are simply too many research reports to keep up with, and you may feel confused. As a member of the Parkinson's disease community, it is important for you to understand the basic clinical research process and how it contributes to advances in the understanding and treatment of PD so you can make the personal decision of whether or not you want to volunteer to take part in a research project.

The decision to participate in a clinical trial is an important commitment that should be made with the help of your family and health care providers.

So just what is a clinical trial? It is a study of the safety and effectiveness of a new drug, treatment, or device. Clinical trials are the fastest and safest way to find new treatments or ways to slow the progression of a disease. They are sponsored and paid for by two main sources: government agencies or biotechnology/pharmaceutical companies. All U.S. research projects are carefully monitored and regulated by existing laws and by the Food and Drug Administration (FDA). At the local level, such as at Oregon Health & Science University, all trial activities are also regulated by a panel of experts called an

Institutional Review Board (IRB), which includes doctors and scientists as well as lay people.

The core of every clinical trial is the protocol or the study plan. The protocol describes specifically what will take place during the study. It also lists the criteria which individuals must meet to be included in the study (for example, people diagnosed with Parkinson's disease in the last five years). The protocol is designed to protect the safety of all volunteers throughout the study.

What are the potential benefits of participating in a clinical trial?

  • Clinical trials may allow access to new treatments before they become available to the public.
  • Clinical trials offer the possibility of quality medical care at leading institutions (though it is not realistic to expect the study team to care for medical problems or concerns beyond those related to the clinical trial).
  • Clinical trials provide an opportunity to contribute to medical research that may help others in the future.

What are the potential drawbacks of participating in a clinical trial?

  • The drug or treatment may not be effective for you.
  • If the study includes the use of a placebo drug or so-called sugar pill, you have a chance of receiving that instead of the active drug or treatment.
  • You may experience side effects from medications or treatments.
  • It takes more of your time and effort than standard treatments prescribed by your regular doctor.

Conducting a clinical trial is a complex and expensive undertaking for its sponsor and for the research staff that implements it. Participation is a significant commitment for each person who enrolls. Being in a study can stir many emotions all the way from hope to stress, and often leads to new friendships with others in the trial.

So why do we conduct clinical trials at the Parkinson Center of Oregon? We in the clinical research staff at the PCO are committed to bringing help for today and hope for tomorrow to those with movement disorders. We value the participation of everyone who volunteers because we could not do our work without your help.

I learned a lot about the drug development and testing process, the disease and myself. I've been involved with research studies since the early '90s and continue to be impressed with the quality of caring of the people involved. They are making dramatic strides in understanding and treating the family of conditions known as PD.

Randy Vinecore