There appears to be a certain stigma behind clinical trials. When introducing it to others, many people automatically think, “I would not like to be a ‘human lab rat’or a ‘professional guinea pig’.”This assumption is outrageous and very stereotypical.
If you opened your medicine cabinets, all of those medications have gone through clinical trials and people volunteered to help put that medication on your shelf. Without clinical trials and people willing to participate in trying the new medication, we would have no new developments in medicine.
Before I get into the basics of what a clinical trial is and explain both the pros and cons, let’s take a minute to remember that every drug started out as an unknown chemical compound that has undergone years of research until it was made available to others.
To begin, a clinical trial is a human research study designed to answer questions about new therapies for certain diseases. It begins as a chemical compound produced in a lab and then it is tested on animals. Slowly but surely, it moves on to being tested on humans. These studies are funded by pharmaceutical companies that want to observe the drug and make sure that it is safe to be put on the market.
There are different types of clinical trials, more specifically there are four different types of phases; Phase 1, Phase 2, Phase 3, and Phase 4.
Phase 1 studies are open to all healthy normal volunteers. By “normal”it means that the individual does not have the disease or disorder that the drug proposes to treat.
Phase 2 studies usually target the patient population for the indication that the drug proposes to treat. The main objective is to look at the safety of the drug and any signs of efficacy (whether the drug works) in this patient population. Basically, a Phase 1 trial determines the dose ranges of a particular drug and a Phase 2 trial determines whether the drug actually works within that dose range.
Phase 3 studies are pivotal studies in which the main objective is to determine whether the drug works in comparison to a placebo (sugar pill).
Lastly, Phase 4 studies are conducted after the drug is approved by the FDA, but labeling issues need to be addressed.
There are potential benefits and risks associated with participating in any trial. As a volunteer you have the right to withdraw your consent at any time during the study.
You should always do your part as an active participant and gather as much information about the trial. It is also beneficial to ensure that all questions are answered by the study doctor and staff before starting the trial.
The participant is compensated for travel as well as for being a participant in the study.
At Breakthrough Clinical Trials, we also run a Parkinson’s support group.
Breakthrough Clinical Trials has a clinical trial available. The clinical trial is a Phase 4 study. The objective of this study is to determine whether 1mg/day of Rasagiline is more effective than a placebo in improving cognitive impairment in Parkinson’s disease – cognition after 24 weeks of treatment.
The 3 main components are (1) documentation of cognitive decline compared with premorbid abilities; (2) documentation of impairment on neuropsychological testing; and (3) lack of significant functional impairment that would make the patient more appropriate for a diagnosis of Parkinson’s Disease Dementia (PDD). The study targets non-demented men or women 45 through 80 years of age with idiopathic Parkinson’s.
For more information about the study or general questions visit, Breakthrough Clinical Trials in the Wellness Village at ParkinsonsResource.org/spotlight/breakthrough-clinical-trials/ and upon entering your name and email address, you will be directed to them.