Education- Clinical Trials

Clinical Trial Phases

Phase I: research strives to show safety in humans after a drug has been shown to be safe in animals. It also serves to collect data on absorption, metabolism and other "in-vivo" properties of the drug. So called first-in-man studies begin with a few dozen healthy subjects who are paid for their participation. 60-80% of phase I medications move on to the phase.

Phase II: research begins what is called "proof-of-concept" research.The study medication has been shown to be safe in humans through phase I and now data is needed to show it is effective. Phase II involves enrolling subjects who have been diagnosed with the condition being treated. Companies conduct small scale studies first to establish the efficacy of a medication before they decide to fund extensive large-scale research. Phase II studies look at a few dozen and then a few hundred subjects in a double-blind placebo-controlled fashion. Double-blind, placebo controlled studies establish the unbiased effect and side effect profile of a drug. Safety and pharmacokinetic data continue to be collected through phase II.

Phase III: research expands on phase II by looking at thousands of subjects. It demonstrates a drug's safety and efficacy in larger numbers which translates into more statistical power. These are large-scale, expensive studies with the ultimate goal of obtaining FDA approval for a given drug.

Phase IV: trials are generally aftermarket studies which may compare one drug to another, for example a competitor's, to achieve a marketing edge. Phase IV trials also collect additional safety data on already approved medications.

Institutional Review Board (IRB)

A panel of individuals whose objective is to approve, review and monitor medical/biological human research in order to maintain and protect the welfare and rights of research participants. They determine if there is a balanced ratio of risk to benefit. The panel must consist of members who are knowledgeable enough to determine if research is ethical and necessary.

The panels consist of both men and women both scientists and members of the community. The panel votes on approval of research study protocols, informed consent forms, and any materials used in the study.

Study Protocol

This is a document that thoroughly outlines and explains all aspects of a research study. It begins by demonstrating the need for conducting the study and explains the actual condition being treated. This is done through a review of literature

The author(s) then present a hypothesis. Research data and available information about the drug through previous phases of the study are presented. Then the actual process of conducting of a study, and the statistical analysis that will be used to present the findings are reviewed. The inclusion and exclusion criteria as well as allowed concomitant medications are listed. The protocol must be reviewed and approved by an IRB conducting the study.

Informed Consent Form and Informed Consent Process

The informed consent form itself is an IRB approved document that explains, in lay-terms, what occurs during the study. It discusses risks, benefits, and treatment alternatives. It also provides contact information of the principal investigator. The informed consent contains an authorization clause to disclose your medical information to the study sponsor and those involved in conducting the study.

The process of informed consent involves providing a potential participant with an informed consent form. It allows them to read and ask questions about the study in a quiet and private environment.  The investigator or his or her designee must be able to answer all questions the participant has to the participant's satisfaction.  The participant and the investigator or designee then sign the informed consent form.  The participant always receives a copy of the informed consent form.

Privacy

In clinical research, healthcare information is labeled with one's initials and a study number; there is no identifying information connected to your data. Participants will have a separate record in the clinic office that lists their name, date of birth, address and phone numbers as it is mandatory to have contact information on site. This information will not leave the office or be used as data. This information may be seen by the study sponsor while monitoring the conduct of the study at the study/clinic office. The FDA may have access to this information in the rare case of an FDA audit. The IRB may have access to identifying information in order to maintain it's responsibilities. No information will be released to insurance companies or anyone else unless requested by the participant.   

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