Clinical trials are monitored and regulated by a variety of entities, including independent bodies that review the trial protocol and data on an ongoing basis to ensure that the trial is ethical and should continue. This fact sheet is for advocates who would like to learn more about how these entities work, what they do, and what impact their recommendations can have on clinical trials.
Data Safety Monitoring Boards (DSMBs)
Treatment as Prevention: Frequently asked questions
This FAQ was developed with input from the National Empowerment Network of People Living with HIV (NEPHAK) and Health GAP on the basis of national PLHIV dialogues on treatment as prevention conducted throughout Kenya. The questions and answers contain information relevant for a global audience—but have been written specifically for individuals living and working in low and middle income countries
Pharmacokinetics and Pharmacodynamics: A primer for HIV prevention advocates
Pharmacokinetics (PK) is the study of what happens to a drug when it is taken into the body; pharmacodynamics (PD) is the study of what happens to the body when a drug is taken. PK/PD research is a central aspect of the search for ARV-based prevention, and this factsheet is for advocates looking to understand some of the basic terms, aims and objectives of PK and PD studies.
FDA’s Advisory Committee Review of Daily Oral Truvada as PrEP to Reduce the Risk of HIV Infection: An advocate’s primer for public participation
This primer was developed to help advocates understand the mechanism of the US Food and Drug Administration’s external advisory committee. It was specifically developed in preparation for the US FDA review of Truvada for use as PrEP in 2012. It offers a guide to the workings of the external advisory committee (a set of outside experts who make recommendations) and ways for civil society to participate in the process.
MPT Product Development & Regulatory Issues 101
This webinar featured experts Dr. Joe Romano (NWJ Group/CAMI) and Dr. Jim Turpin (NIAID) who provided updates on the state of multipurpose prevention technologies (MPTs) research, the pipeline and potential manufacturing and regulatory pathways. MPTs are being developed to simultaneously prevent unintended pregnancy and protect against HIV and other sexually transmitted infections.Click to access the webinar slides and recording.
Female-Initiated HIV Prevention: What will we learn from upcoming trials?
A 2007 document developed in anticipation of data from the Carraguard microbicide and MIRA diaphragm trials of women-initiated prevention strategies. It contains explanations of trial design and possible outcomes.
An Action Agenda to End AIDS: Critical actions from 2012-2016 to begin to end the HIV/AIDS pandemic
Released at AIDS 2012, this report lays out a plan for beginning to end HIV/AIDS. It includes clear time-bound outcome targets, as well as the responsibilities of different stakeholders to achieve these targets.
Anticipo de los Resultados de Ensayos de PrEP: Una poderosa herramienta nueva para la prevención del VIH podría estar cerca. ¿Estamos preparados para ella?
A 2008 document providing background information on pre-exposure prophylaxis (PrEP) and discussing efficacy trials that were then planned and ongoing. It discusses the research agenda and key advocacy priorities to move PrEP research forward.
Anticipating the Results of PrEP Trials: A powerful new HIV prevention tool may be on the horizon. Are we prepared?
A 2008 document providing background information on pre-exposure prophylaxis (PrEP) and discussing efficacy trials that were then planned and ongoing. It discusses the research agenda and key advocacy priorities to move PrEP research forward.
An Action Agenda to End AIDS: Quarterly monitoring report
The first update to An Action Agenda to End AIDS gives a status report on key actions and provides priority recommendations.