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PROGRAM Microbicides Clinical Studies Population Council researchers are testing promising microbicidal compounds, developed by the organization's biomedical scientists, in human tests known as clinical trials. Once laboratory research has shown that human testing of a promising microbicide is warranted, a Phase 1 safety trial is conducted with a small number of healthy volunteers to ensure that the product is acceptable and does not cause harm to people. An expanded safety, or Phase 2, trial is then undertaken with more participants over a longer period to further confirm the formulation's safety, its acceptability to its users, and, in some cases, to preliminarily gauge its efficacy.
Phase 3 studies test for efficacy and involve the largest number of participants. (For information on the results of the Phase 3 trial of Carraguard®, the Council's candidate microbicide, see the news release.) Such studies form part of the process of bringing a new pharmaceutical product, such as a microbicide, safely to the consumer. Local regulators oversee these trials, as the South African Medicines Control Council did for the Carraguard Phase 3 study. Before and during all these trials, other activities also take place. Ensuring that women can truly give informed consent to participating in a trial; encouraging local community members and organizations to learn about and become involved in trials taking place in their community; conducting research to understand the conditions under which women will be using microbicides, and scaling up local clinics to meet trial needs—these and many other activities are aimed at creating a life-saving product in an ethical, practical, scientifically sound manner. More detailed information on all phases of testing and microbicides-related research can be found at:
See Also
Contact: microbicide@popcouncil.org Carraguard® is the Population Council's US trademark for pharmaceutical preparations, namely microbicides, for use in preventing infection.
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