I asked my then 12 year old daughter Alisha, “If I were asked to take a medication that few or no other people with Parkinson’s Disease have taken before, what would you say?”
“I would have to ask a few questions”, was her reply.
This is the mind-set that we should all have when it comes to clinical trials. For the many people who support clinical trials, no explanation is necessary to help them decide to participate. For those who don’t feel the need to particiapte, no explanation will change their mind. My goal is to provide enough information to those in the middle ground whose decision is based on the facts as they relate to participating in cinical research. Clinical trials have not always had the best of reputations, but times have changed for the better with more over-sight of the process. Although there is inherent risk in anything that we do in life, clinical trials allow us to be a part of the process that invvolves finding a cause and a cure for this debilitating disease. The type and scope of clinical trials can give many opportunities for participation. Different phases and different types of trials are available at many locations. Most clinical trial types are divided into Interventional and Observational categories. In the case of compounds being tested, most of us with P.D. will participate in Phase II and Phase III trials. These drug trials provide a person interested in novel compounds a chance to take these medications, sometimes years before they become available on the market.
Other equally important trials are those that will help develop lab tests and diagnostic tools to make it easier to diagnose P.D. and trials that can find ways to alleviate the symptoms of P.D. Some clinical trials are as simple as filling out questionnaires, keeping a diary and providing blood samples, or having a neurological exam done. It is up to the person with P.D. to decide which ones to look into and find out if they qualify as a participant, based on pre-set criteria. This has been made easier with the introduction of the Fox Trial Finder. (Find Parkinson’s Clinical Trial Opportunities, visit http://www.foxtrialfinder.org) I have met people who have particiapted in trials involving brain surgery for gene replacement therapy, some involved in trials based on questionnaires, and everything in between. The choice is yours. The most important part about the process of involving yourself in clinical trials is finding out as much as you can, and questioning as much as you need, to come to a decision.
There are 7 ethical requirements that researchers have to follow:
1. The research has to have value to society. 2. The research has to have scientific validity. 3. Selection of participants has to be fair. 4. There must be a positive risk-benefit ratio. 5. There must be independent review of the research. 6. There must be informed consent by the participants. 7. There must be respect for the participants in relation to privacy and having their well-being monitored.
A thorough explanation of the consent form is the last step before starting the process. You have the right to stop participating at any time during the trial, but you also have the responsibility to follow the protocol as it has been set out for you in order to safeguard the integrity of the trial. Many people are available to answer your questions, but the decision should be yours alone. Am I doing this because I may get medications that are years away from possible FDA approval? Am I doing this because I want to help push research forward? Am I doing this because I have a desire to help make a difference? Whatever your reasons, remember that finding a cause and a cure will not be possible without us as partners in the process. They can’t do it without us. Getting involved will help get this disease to “stop”.