Before a drug is ready for clinical trial management in real patients, it must first be thoroughly tested in animals. The first time it is administered to humans, it must be tested on healthy volunteers to determine whether it is safe, to see how it changes in the body (pharmacokinetics), how it affects the body (pharmacodynamics) and to determine the highest tolerable dosage. This is called a Phase I trial.
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 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.
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 the trial can begin, the protocol needs to be approved by the Food and Drug Administration, by an ethics committee and by each one of the institutions where the study will take place. The role of the ethics committee is to safeguard the safety, rights and well-being of the patients. They pay special attention to vulnerable populations, including but not limited to children and the elderly.
The documents that the Ethics Committee is most interested in are the consent form and the accompanying patient information leaflet (PIL). Both documents must be written in language that the intended population is likely to understand. The PIL must carefully outline any potential side effects that may be anticipated. Care must be taken to make sure that any risks included in the Investigator's Brochure, a separate document, are included in the PIL and carefully explained.
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.
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 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.
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 the trial can begin, the protocol needs to be approved by the Food and Drug Administration, by an ethics committee and by each one of the institutions where the study will take place. The role of the ethics committee is to safeguard the safety, rights and well-being of the patients. They pay special attention to vulnerable populations, including but not limited to children and the elderly.
The documents that the Ethics Committee is most interested in are the consent form and the accompanying patient information leaflet (PIL). Both documents must be written in language that the intended population is likely to understand. The PIL must carefully outline any potential side effects that may be anticipated. Care must be taken to make sure that any risks included in the Investigator's Brochure, a separate document, are included in the PIL and carefully explained.
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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