Behavioral Health Clinical Trials

There are two basic principles of GCP. The first involves protecting the research patient or volunteer. The second involves collecting accurate data that can be replicated. One of the reasons that GCP was introduced and accepted was because of concern about drug safety. In particular, there was public anxiety among regulators about the quality and reliability of the research data submitted to regulatory authorities. Fraudulent data could jeopardize patient safety or cause rejection of an application for a new drug with the potential for curing illness. Fraudulent data usually emphasized the efficacy and underplayed the toxicity of a drug. GCP helps address and eliminate these risks.

Pharmaceutical companies around the world are engaged in more research now than ever before in the history of medicine. It is through the research process that new treatments are discovered to treat illnesses that might otherwise be incurable or unmanageable. Without research, many diseases that have been controlled or have been cured would still plague the world.

Various government agencies are charged with regulating medications, medical devices, and medical treatments. The primary goals of this regulation are to make sure that the medications available in the United States are both safe and effective in the treatment of particular illnesses. Clinical trial research tests the use of medications that are currently available by prescription and investigates the possibility of medications being made available without a prescription. This improves safety for patients and can expand the number of people who have access to needed medications. Research also looks at the cost of medications and the worth of the expense to society.

Research is done by a variety of different organizations and groups. The National Institutes of Health, the Food and Drug Administration (FDA), private foundations, and pharmaceutical companies are some of the groups that perform clinical trials. Other branches of industry and government may request or sponsor research. Universities, government agencies, and research centers are common research settings for clinical trials.

All participants in clinical trials are volunteers and chosen for different reasons, depending on the study. Some types of studies require participants who are healthy and not suffering from any current illnesses. These studies are largely for the purpose of investigating the metabolism of a drug.

For most studies, participants must be diagnosed with a specific illness or disease. A physician or other licensed professionals will take a detailed history, perform a physical examination, and review laboratory tests to make sure that the diagnosis is correct. They will also ensure that no other illness will confound the results of the study or endanger the patient’s health or safety.

Volunteers come to the clinic from a variety of sources, including referrals from physicians, hospitals, and previous study participants. They may also be chosen from their response to an advertisement or other public notices.

Before a medication or treatment can be used in general medical practice, it has to be proven to be safe in a laboratory or research clinic setting. Before a volunteer begins participation in a research study, the potential risks and side effects of the experimental medication are explained to them in detail. The participant signs a consent form that reviews the study design, and the safety and efficacy profile of the medication being studied. The research itself is conducted under the supervision of a physician and their staff, and a medical monitor from the sponsoring agency, organization, or pharmaceutical company.

All participants in a clinical research study have a medical chart at the research company. This includes the results of the initial history and physical examination, laboratory tests, cardiograms, and the results of any other medical procedures. Upon request, these records can be sent to your own physician for inclusion in your permanent record.

For each study, a copy of the experimental protocol and complete information about the medication is reviewed by an independent Institutional Review Board (IRB) member or ethics committee. No volunteers can be entered into a research study before a committee has approved of the research protocol, the advertisements for the research, and the consent form that explains the research to the participant.

Payment for participation in clinical trials varies according to the research project, medication, disease under investigation, and phase in the development cycle of the study. Often the cost of transportation will be reimbursed. For phase I and early phase II studies, where there are no long-term therapeutic benefits to participants, often compensation is given for the time involved, and any discomfort caused by the experimental procedures. Discussion and agreement upon any monetary or other types of payment for participation in all phases will be discussed before beginning a clinical trial.

For a medication to be shown effective, it has to be compared with an inactive substance or placebo medication. If the medication is no better than the placebo, the conclusion from the research is that it doesn’t work. In addition, experimental medications are often compared against a marketed compound. To be a useful medication, it should be as effective as a medication currently on the market and better than a placebo. Interestingly, 30-40% of volunteers who take placebo medication get relief from their symptoms.

Volunteers sometimes are diagnosed with an illness or disease at the end of their participation. When this happens, follow-up medical care is often provided, including follow-up visits with the physician or someone on their staff, and in some cases, medication for three months. We then refer patients back to their regular physicians with recommendations for treatment.

Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each volunteer before that person participates in the research study.

The IRB is a group of healthcare professionals and non-scientific members which must review and approve a clinical study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of participants.