Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention.
An institutional review board (IRB) reviews the study for safety. Each study is evaluated by the IRB to determine that it complies with regulatory guidelines to ensure participant safety and well-being. The IRB is made up of members of the community. The IRB includes individuals not associated with NEUROMEDICAL RESEARCH INSTITUTE, including both medical and non-medical professionals.
NEUROMEDICAL RESEARCH INSTITUTE physicians and clinical staff review each study. Our physicians, practitioners and clinical staff have a significant amount of experience conducting clinical research. The specific risks associated with any research protocol are described in detail in the informed consent form (ICF), which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks.
There are many reasons why people volunteer to become part of clinical research trials. Some people volunteer because they may be helped by a new treatment or procedure. Others join because they want to help in the discovery of new treatments, procedures, or medications that may benefit patients in the future.
Clinical trials are a critical component in expanding treatment options for all diseases and disorders. Clinical trials rely on patient volunteers to investigate different ways to treat disease, using investigational drugs — also called study drugs — and experimental ways of giving drugs to determine if they are safe and effective.
Since all new therapies must be evaluated through research studies, the greater the number of people who participate, the faster emerging therapies can be brought to market. These trials also provide patients with access to therapies that are still in development, but might offer specific advantages for their particular issue.
Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second group receives a standard treatment or placebo.
Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. Blinding allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies. Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. Seventy to ninety percent of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.