Tuesday, January 21, 2014

Basic Principles Of Clinical Trial Management

By Marissa Velazquez

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 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 protocol reaches this stage, the feasibility team becomes involved. At this point, meetings are held in person and over the internet with KLOs who may or may not participate in the actual trial. They contribute detailed information as to the practicalities involved in conducting the trial under that protocol. This involves a lot of delicate negotiations and juggling of high-powered egos. Several reiterations of revisions and discussions often take place before the final protocol is in place.

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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