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Participant Stories
“I participate because it is the right thing to do, for myself, for my children, and for the millions of people who have Parkinson’s disease. Without participation there will be no cure.” –Mike, Diagnosed 7 years
Recently Diagnosed with Parkinson's Disease?
If you have recently been diagnosed with Parkinson’s disease (PD) understanding the disease, and learning about the resources available to you, are good first steps.
How Does a Clinical Trial Start?
Researchers who have an idea about a possible treatment for Parkinson’s disease (PD) first study any literature that exists on the particular drug or therapy. TherapyAnother word for “treatment”. Next, they perform extensive chemical and biological studies to learn more about the properties of the drug in question. If these are successful they then conduct animal studies to learn about potential toxic effects and to determine a reasonable dose for testing in humans. If the results are found to be promising, they are then submitted to the FDA in an extensive document called an Investigational New Drug Application Investigational New Drug (IND) ApplicationThe vehicle through which a sponsor advances a new drug from preclinical development, including animal studies, to clinical trials, involving human participants. (IND), which summarizes the studies done to date and serves as a study plan (protocol) ProtocolA plan that is the basis for the conduct of a clinical trial ensuring the health of participants, and the solutions to specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. for research in humans. This contains a summary of what is known about the treatment to date, why it might be expected to work for a given condition, and any known risks and benefits for those who participate. It also clearly states the eligibility criteria Eligibility CriteriaGuidelines for determining who can qualify to participate in a specific clinical trial. Requiring that all participants share certain characteristics (e.g. age, gender, medical history) ensures that trial results will be due to what is under study and not other factors, helping researchers achieve accurate and meaningful results. of study participants, the procedures for enrolling participants (known as informed consent) Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. and how long the study should last.
The protocol is subject to FDA evaluation to ensure that risks to participants are reasonable and that the study is well designed. Assuming that the research proposal is found to be scientifically sound by the FDA, the protocol and informed consent forms (which participants sign to document that they have given their written consent to participate) are submitted by the investigator or trial sponsor SponsorOrganizations, medical institutions, foundations, pharmaceutical companies, or federal agencies (e.g. National Institutes of Health, Department of Defense, and Department of Veteran's Affairs) that fund clinical trials. to the Institutional Review Board Institutional Review BoardA committee of physicians, statisticians, researchers, community advocates, and others chosen by an institution to initially approve and periodically review research projects involving human participants. Federal law requires this to ensure protection of participants’ safety, rights and welfare. (IRB) IRBA committee of physicians, statisticians, researchers, community advocates, and others chosen by an institution to initially approve and periodically review research projects involving human participants. Federal law requires this to ensure protection of participants’ safety, rights and welfare. . The IRB is based at the hospital, university or research center where people will be asked to volunteer as study participants.
The IRB Committee is made up of clinicians, researchers, consumers (often patients) and ethicists. The role of the IRB committee is to review the protocol and the thoroughness and clarity of the written consent forms that describe every part of the study including what to expect, and what risks and responsibilities the volunteer is asked to accept. The job of the IRB is to protect study participants. Before approval, the IRB must be able to determine that the potential benefits outweigh the risks to participants and that the consent process clearly and explicitly communicates the study to the participant. If approved, the study is reviewed at least annually by the IRB to ensure that it is conducted safely and ethically.
