1. Why are clinical trials needed?
The medical profession is constantly searching for new or better treatments for a wide range of illnesses and diseases. The large numbers of discoveries that are made cannot be put into general use until controlled evaluations have been completed with actual patients. The only scientifically valid way that these evaluations can be completed are through clinical trials. The Food and Drug Administration (FDA) requires closely monitored clinical trials before it can approve a new treatment as safe and effective for public use.
2. Who conducts clinical trials?
Pharmaceutical companies, research institutions and health organizations may sponsor a clinical trial. A protocol is a set of detailed guidelines that research organizations, like CALNEURO, are required to follow to conduct a well-controlled and scientifically valid clinical trial. Although pharmaceutical companies may sponsor (i.e. provide grant monies for) a clinical trial, only trained doctors, nurses, and medical researchers conduct the trial itself.
3. Why should I participate in a clinical trial?
It is possible the experimental treatment being tested will be beneficial to your health. A new drug or new treatment may reduce symptoms or cure your illness.
Every day, there are people hoping for more effective treatments for an illness or disease. Clinical trial volunteers help make those discoveries a reality. Many participants find great satisfaction in contributing to scientific research that may benefit many others.
4. Who is eligible to be in a clinical trial?
Each clinical trial attempts to answer very specific research questions. You must meet the requirements of a trial to be an eligible candidate. To do this, each trial has specific health requirements, including medications you may be taking, your age, and other things. Please don’t hesitate to ask CALNEURO staff about the eligibility requirements for a particular trial.
5. What is a clinical trial like?
Participating in a clinical trial is similar to a regular visit to a medical clinic, hospital or doctor's office, but with individualized personal attention. Once you have enrolled in a study, you will be asked for your medical history and receive a physical examination. You will be given a consent form that outlines a detailed description of the clinical trial and what is expected of participants.
In a clinical trial, each volunteer is assigned to a study group. Volunteers in one study group will receive the trial drug. Another group of volunteers will receive a placebo or a treatment that is already commercially available.
Placebos are harmless, inactive products used to compare the results of the trial drug. None of the participants or the research staff will know who is receiving the investigational drug or the placebo. This will maintain the objectivity of the clinical trial. Whether you receive the placebo, a currently marketed medication, or the investigational drug, the level of medical attention and care that you receive will remain the same.
6. What is needed of me?
Your first responsibility is to fully understand your commitment to be honest throughout the trial. The trial investigators and sponsors need you to arrive at your appointments on time, to follow their instructions carefully, and take all medication according to instructions. It is extremely important to take the trial seriously. Your full cooperation is mandatory to ensure investigators collect the information they require for a successful study.
7. What can I expect from the clinical trial team?
More than anything else, you have the right to expect complete transparency about the trial. If you have any questions or concerns, do not hesitate to ask a CalNeuro staff member.
8. Why do I need to know if I suffer from a psychiatric disorder?10. Why should I take psychiatric medications?
An accurate diagnosis is essential for effective treatment. Lack of a proper diagnosis and appropriate treatment can have potentially harmful consequences. A proper diagnosis may also relieve some of the confusion, shame and other negative feelings about psychiatric problems.
9. How am I protected as a clinical trial participant?
Informed consent protects your rights by ensuring you have been given all the necessary information about the clinical trial. Advertisements for clinical trials are regulated by the IRB’s and FDA to reduce misleading claims.
CalNeuro is committed to confidentiality. Participation in a clinical trial means your privacy is protected. CalNeuro medical records are confidential. The trial data that is provided to the pharmaceutical company and the FDA will not include your name or the names of any individuals participating in the study.
According to the Declaration of Helsinki (worldwide ethical principles regarding human experimentation; prepared and approved by the World Medical Association), the fundamental principle is deference for the individual, the right to self-determination and the right to make informed decisions regarding participation in research. The participant's welfare and ethical considerations must always take precedence over the interests of science, as well as over laws and regulations. The FDA has also adopted and implemented the international quality standard of Good Clinical Practice Guidelines (GCP) for clinical trials, which includes strict standards on how clinical trials must be conducted. GCP guidelines prioritize the protection of human rights for all subjects in clinical trials and provides assurance of the safety of the newly developed compounds.
Glossary of Terms
InstitutionalReview Board (IRB): A committee used to regulate research that is formally designated to approve, monitor and review biomedical and behavioral research in the United States. The IRB is also responsible for ensuring that there is no unreasonable risk to the patient and that the informed consent form correctly informs the participant about his/her role in the study, along with the potential risks and benefits associated with participation.
Clinical Trial: A closely monitored scientific study that tests the efficacy of a potentially new medical treatment, drug, or device with patients.
Clinical Investigator: A medical researcher in charge of implementing, monitoring and a clinical trial's protocol. Pharmacology Research Institute's physicians are clinical investigators.
Food and Drug Administration: The government agency that sets guidelines for the manufacture, research, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be available for public use.
Informed Consent Form: An agreement between clinical investigators and potential participants that meticulously outlines all procedures, benefits, risks, and expectations of a clinical trial. The FDA requires all participants to sign an informed consent form before partaking in a trial.
Investigational Treatment: The drug or device that is being researched during a clinical trial.
Pharmaceutical Company: A business that investigates, researches, develops, manufactures, and/or sells medical drugs, treatments and devices.
Protocol: A highly detailed and carefully written plan designed by a clinical trial sponsor and reviewed by the IRB and the FDA. The protocol sets guidelines for a trial and is universal for all trial locations for a particular treatment.
Sponsor: The research institution, pharmaceutical company or other health/governmental organization that funds a clinical trial.
Standard Treatment: A treatment or medication currently marketed in the United States and approved by the FDA. In some trials involving experimental drugs or treatments, there may be no other pre-existing treatment. In these cases, the lack of any treatment itself is the standard treatment.