Before a new drug can be unleashed on the innocent public, it must go through several rounds of clinical trial management. The first attempt at administering a new medication in humans is conducted on limited numbers of healthy individuals in what is known as a Phase One trial. Here, information is collected on the safety of the drug, its pharmacodynamics (how it affects the body), the highest tolerable dose of the drug and how the drug is changed in the body (pharmacokinetics).
The second stage, Phase II, involves administering the drug to a population of patients who have been diagnosed with the condition for which the drug has been designed. This is called a "proof of concept" trial. The numbers of patients are carefully calculated by a statistician.
During Phase 2, the protocol is written. This is a legal document that sets out all of the procedures, investigative medical product (IMP), laboratory tests, etc., that will be performed on the patients in the trial. The protocol is jointly written by clinical scientists, members of the medical community called key opinion leaders (KOLs). The KOLs are leading physicians in their fields who contribute a lot of valuable information to the design of the protocol.
The clinical trial protocol is the central document in the study. It must be written in a way that protects the health and welfare of the patients, provide information on why the trial is being conducted, and describe the inclusion and exclusion criteria for recruiting patients. The level of detail included in the trial protocol goes right down to what temperature the investigational medicinal product (IMP) must be stored.
Once the first draft protocol has been "finalized, " a separate team conducts feasibility studies. This involves having meetings with medical doctors who might wish to incorporate the drug trial in their practice. Here, detailed information is gathered as to the number of patients the practice could reasonably recruit into the trial, whether they have the necessary resources. Several cycles of protocol revisions and negotiations take place between the various members of the team during this phase of the project.
Before a single dose of drug may be issued to a patient, the protocol has to be approved by a number of agencies: the competent regulatory authority (in the United States of America, this is the Food and Drug Administration (FDA)), an ethics committee and the institutional review board of every hospital and institution where patients will be seen. Special attention is paid to vulnerable populations, such as the elderly and children.
The ethics committees are particularly interested in the consent form that must be signed before each patient undergoes any procedures and its accompanying patient information sheet (PIS). The PIS must carefully explain each procedure and any anticipated side effects. Each and every risks that are outlined in a separate document for the participating physicians, called the Investigator's Brochure, must be included in the PIS.
Clinical trial management is a lengthy, complicated process. This is necessary to keep bad drugs out of the marketplace and to protect the safety, dignity and well-being of the subjects. It is also necessary to make sure the research answers the right questions.
The second stage, Phase II, involves administering the drug to a population of patients who have been diagnosed with the condition for which the drug has been designed. This is called a "proof of concept" trial. The numbers of patients are carefully calculated by a statistician.
During Phase 2, the protocol is written. This is a legal document that sets out all of the procedures, investigative medical product (IMP), laboratory tests, etc., that will be performed on the patients in the trial. The protocol is jointly written by clinical scientists, members of the medical community called key opinion leaders (KOLs). The KOLs are leading physicians in their fields who contribute a lot of valuable information to the design of the protocol.
The clinical trial protocol is the central document in the study. It must be written in a way that protects the health and welfare of the patients, provide information on why the trial is being conducted, and describe the inclusion and exclusion criteria for recruiting patients. The level of detail included in the trial protocol goes right down to what temperature the investigational medicinal product (IMP) must be stored.
Once the first draft protocol has been "finalized, " a separate team conducts feasibility studies. This involves having meetings with medical doctors who might wish to incorporate the drug trial in their practice. Here, detailed information is gathered as to the number of patients the practice could reasonably recruit into the trial, whether they have the necessary resources. Several cycles of protocol revisions and negotiations take place between the various members of the team during this phase of the project.
Before a single dose of drug may be issued to a patient, the protocol has to be approved by a number of agencies: the competent regulatory authority (in the United States of America, this is the Food and Drug Administration (FDA)), an ethics committee and the institutional review board of every hospital and institution where patients will be seen. Special attention is paid to vulnerable populations, such as the elderly and children.
The ethics committees are particularly interested in the consent form that must be signed before each patient undergoes any procedures and its accompanying patient information sheet (PIS). The PIS must carefully explain each procedure and any anticipated side effects. Each and every risks that are outlined in a separate document for the participating physicians, called the Investigator's Brochure, must be included in the PIS.
Clinical trial management is a lengthy, complicated process. This is necessary to keep bad drugs out of the marketplace and to protect the safety, dignity and well-being of the subjects. It is also necessary to make sure the research answers the right questions.
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