Should I participate in Research ?

People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free. The patient's rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the NIH must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.

Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.

GCP (Good Clinical Practice)

The basic principles of GCP (Good Clinical Practice) are for the protection of the research patient or volunteer and second to collect data that can be replicated and is correct. 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 some of the research data submitted to regulatory authorities. Fraudulent data could jeopardize patient safety or could cause rejection of an application for a new drug with potential for curing illness. Fraudulent data usually emphasized the efficacy and underplayed the toxicity of a drug. For more info: http://www.ich.org/LOB/media/MEDIA482.pdf

WHY do research ?

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

WHAT are the goals ?

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. At times, research also looks into new uses for medications that are currently available by prescription, or investigate the possibility of medications being made available without prescription. Other areas of research include Pharmacoeconomics which is the science of looking at the cost of medications, and the worth of that expense to society.

WHO does research ?

Research is conducted in a number of different settings. Universities, government agencies, and research centers are a few of these research settings. The National Institutes of Health, the Food and Drug Administration (FDA), private foundations, and pharmaceutical companies, as well as other branches of industry and government may request or sponsor research.

HOW are participants chosen?

All participants in clinical trials are volunteers. For some types of studies, participants for a study who are healthy, and not suffering from any current illness are recruited. These studies are largely for the purpose of investigating the metabolism of a drug. There is often no therapeutic benefit to those participants other than contributing to medical science, and on some occasions a payment for their time and assistance. 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, and 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 physician and hospital referral, referral by previous study participants, and response to an advertisement or other public notices.

IS research safe ?

Before a medication or treatment can be used in a 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 from the pharmaceutical company.

CAN I have a copy of my records ?

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.

WHO reviews the ethics of the research ?

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

WILL I be paid to Participate?

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 is no long-term therapeutic benefits to participants, often compensation is given for the time involved, and any discomfort caused by the experimental procedures.

WHY do some studies include a placebo ?

For a medication to be shown effective, it has to be compared with an inactive substance or placebo medication. If it 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 medication currently on the market, and better than placebo. Interestingly, 30-40% of volunteers who take placebo medication get relief of their symptoms.

WHEN the research is over, what happens to me?

Because volunteers have been diagnosed with an illness or disease, at the end of their participation, follow-up medical care is often provided. This service includes 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.

WHAT is Informed Consent?

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 research volunteer before that person participates in the research study.

WHO is the Institutional Review Board (IRB) ?

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 study participants.