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.
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 protocol is a carefully written procedural method designed first and foremost to protect the health, dignity, privacy and well-being of the patients. It also provides information on the rationale behind the trial and the type of patients that will participate. The level of detail drills down right to the temperature at which the drug must be stored.
During feasibility, the study team meets with medical doctors who may or may not become involved in the actual trial. Known as Key Opinion Leaders (KOLs), these doctors provide valuable information about the trial. They offer feedback on the existing protocol and propose changes. Information is gathered as to what resources are necessary at each study center to be able to conduct the trial effectively. A seemingly endless series of iterations of protocol revisions and further feasibility is conducted to arrive at the final trial protocol.
Before any drug may be dispensed to the first patient, the protocol must be approved by the Competent Authority of each country that is participating in the study. In the United States, this is the Food and Drug Administration (FDA). The protocol must also be approved by an ethics committee, whose primary role is to safeguard the rights, dignity and well-being of the patients, and also by an institutional review board for each hospital or other institution where patients will be seen.
The two key documents of particular interest to the ethics committee, along with the study protocol, are the consent form and the patient information leaflet (PIL). Both must be in language that is understandable to the population being studied. Any risks that are listed in a separate document for the participating physicians, the Investigator's Brochure, must each be addressed in the PIL.
Clinical trial management is a complex process involving literally hundreds of people for even the smallest trial. Once the Phase II trials are complete, and the concept has been proven, the next stage before a drug goes to market is a Phase III trial. Here, the drug is tested in larger numbers of patients.
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.
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 protocol is a carefully written procedural method designed first and foremost to protect the health, dignity, privacy and well-being of the patients. It also provides information on the rationale behind the trial and the type of patients that will participate. The level of detail drills down right to the temperature at which the drug must be stored.
During feasibility, the study team meets with medical doctors who may or may not become involved in the actual trial. Known as Key Opinion Leaders (KOLs), these doctors provide valuable information about the trial. They offer feedback on the existing protocol and propose changes. Information is gathered as to what resources are necessary at each study center to be able to conduct the trial effectively. A seemingly endless series of iterations of protocol revisions and further feasibility is conducted to arrive at the final trial protocol.
Before any drug may be dispensed to the first patient, the protocol must be approved by the Competent Authority of each country that is participating in the study. In the United States, this is the Food and Drug Administration (FDA). The protocol must also be approved by an ethics committee, whose primary role is to safeguard the rights, dignity and well-being of the patients, and also by an institutional review board for each hospital or other institution where patients will be seen.
The two key documents of particular interest to the ethics committee, along with the study protocol, are the consent form and the patient information leaflet (PIL). Both must be in language that is understandable to the population being studied. Any risks that are listed in a separate document for the participating physicians, the Investigator's Brochure, must each be addressed in the PIL.
Clinical trial management is a complex process involving literally hundreds of people for even the smallest trial. Once the Phase II trials are complete, and the concept has been proven, the next stage before a drug goes to market is a Phase III trial. Here, the drug is tested in larger numbers of patients.
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