A strategy to ensure clinical trial participants are following the appropriate procedures for using the drug product (placebo or active drug). Sometimes, this means the research center staff observes the participants use the product. Other times, the participants must keep a record of their use and return unused products. In the case of some microbicides, participants may be asked to return used applicators.
A committee of independent clinical research experts who review data while a clinical trial is in progress. The DSMB ensures that participants are not exposed to undue risk and looks for any differences in effectiveness between the experimental and control groups. The DSMB may review the data in such a way that they know which group received the drug and which group did not. This group may also recommend that a trial be modified or stopped if there are safety concerns or if the trial objectives have been achieved.
A type of cell that picks up foreign substances from the bloodstream and carries them to the immune system, activating an immune response against the invading substance.
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. (ref. ICH Q8)
Deoxyribonucleic acid, or DNA, is the molecules inside cells that carry genetic information and pass it from one generation to the next. To infect a human cell, HIV must convert its genetic material, RNA, into DNA using reverse transcriptase.
design of experiment
A clinical trial in which neither the study staff nor the participants know which participants are receiving the experimental drug, the placebo or another therapy. Double-blind studies are thought to produce the most reproducible, objective results, since the researcher’s and volunteer’s expectations about the experimental drug do not affect the outcome.
The final formulated product to be tested in a clinical trial and later provided to consumers. It includes the active pharmaceutical ingredient(s) along with other non-active components or excipients.
Drug Safety Monitoring Board