Before a drug can be put to market for public consumption, it must first be put through three phases of clinical trial management. In the first phase, the drug is tested on a limited number of healthy volunteers. This is done to find out whether the drug is safe, determine its pharmacokinetics (how the drug changes in the body), pharmacodynamics (how the body changes the drug) and find out if there are any potential side effects.
The second stage, Phase 2, involves giving the drug to actual patients who have been determined to have the disease the drug was designed to treat. This is called proof-of-concept and is done to see if the drug actually works. A larger number of patients are enrolled in Phase 2 trials than in the previous phase.
At this time, the Phase Two protocol is written at the same time that feasibility studies are being conducted. These two tasks must run together because information from the feasibility feeds into the protocol. The study protocol is the central, legal document in the running of the trial. It includes all medications, laboratory tests and procedures that will take place during the study.
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.
The process of clinical trial management is so complex and fraught with pitfalls, it is a miracle that any drug makes it to the marketplace. Another purpose of having clinical trials is to prevent "bad" drugs from making it to market. This can only be achieved by a huge team of as many as hundreds of dedicated professionals.
The second stage, Phase 2, involves giving the drug to actual patients who have been determined to have the disease the drug was designed to treat. This is called proof-of-concept and is done to see if the drug actually works. A larger number of patients are enrolled in Phase 2 trials than in the previous phase.
At this time, the Phase Two protocol is written at the same time that feasibility studies are being conducted. These two tasks must run together because information from the feasibility feeds into the protocol. The study protocol is the central, legal document in the running of the trial. It includes all medications, laboratory tests and procedures that will take place during the study.
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.
The process of clinical trial management is so complex and fraught with pitfalls, it is a miracle that any drug makes it to the marketplace. Another purpose of having clinical trials is to prevent "bad" drugs from making it to market. This can only be achieved by a huge team of as many as hundreds of dedicated professionals.
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