The Clinical Trial Management Life Cycle
>> Monday, January 13, 2014
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 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 stage, protocol design occurs in tandem with feasibility studies. The protocol is written by scientists employed by the drug company (if the drug is a commercial preparation) in tandem with specialist medical doctors in the field and by the clinical operations team assigned to the project. A clinical trial protocol is a legal document outlining all of the procedures, medications, tests, etc., that will be used to conduct the trial.
The protocol outlines the reasons for conducting the trial and is written with the safety of the patients foremost in everyone's minds. It includes the inclusion and exclusion criteria for enrolling patients into the trial. The level of detail goes right down 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 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 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.
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 stage, protocol design occurs in tandem with feasibility studies. The protocol is written by scientists employed by the drug company (if the drug is a commercial preparation) in tandem with specialist medical doctors in the field and by the clinical operations team assigned to the project. A clinical trial protocol is a legal document outlining all of the procedures, medications, tests, etc., that will be used to conduct the trial.
The protocol outlines the reasons for conducting the trial and is written with the safety of the patients foremost in everyone's minds. It includes the inclusion and exclusion criteria for enrolling patients into the trial. The level of detail goes right down 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 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 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.
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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