Materials and Links

Background:

Strong consensus regarding the critical need for research to support the antiretroviral treatment roll-out programs in resource-limited settings exists. However, several issues present barriers to the implementation of HIV treatment research programs. Examples of such barriers include lack of training and infrastructure, non-overlapping funding streams for treatment vs. research programs, lack of harmonization between regulatory agencies, and barriers to accessing antiretroviral drugs for research programs. The Forum for Collaborative HIV Research’s project “HIV/AIDS Clinical Research in Resource Limited Settings” consists of a series of roundtable discussions to specifically address the latter.

The first of these roundtables convened on September 19th 2005, focused on mechanisms to access drugs for public sector funded clinical research. The goals of this first session were to provide clarity regarding the use of public funds for purchasing drugs for clinical research, review barriers to accessing drugs for clinical research in resource limited settings, review the impact of these barriers on research programs and international collaborations, and discuss strategies for overcoming these barriers.

Future roundtables are planned to address industry donation related issues, including topics such as the role of innovator and generic/copy drug companies in supporting treatment strategy and treatment optimization research, working towards harmonization of regulatory requirements, and facilitating the donation process; and ethics, responsibilities and the respective roles of developing and developed nations public sectors.

Objectives:

This project focuses on the challenges and issues in accessing drugs for clinical research in the resource limited setting. There will be a series of roundtable discussions bringing together researchers government representatives, community representatives, pharmaceutical representatives and other leaders. The first roundtable discussion will focus on mechanisms to access drugs for public sector funded clinical research with the goal of providing some clarity with regards to the use of public funds for purchasing drugs for clinical research, review the impact of these barriers on research programs and international collaborations, and discuss strategies for overcoming the barriers.

Status:

The September 19, 2005 roundtable discussion was supported by a project specific grant from the HIV Medical Association of the Infectious Diseases Society of America. The roundtable discussion was moderated by Professor King Holmes (University of Washington, Seattle) and Ambassador Michel Kazatchkine (Ministry of Foreign Affairs, France). A meeting report will be available shortly.

The Steering Committee for this project includes:

Ben Cheng - Forum for Collaborative HIV Research, USA
Mark Dybul - Office of the Global AIDS Coordinator, USA
Gregg Gonsalves - Gay Men's Health Crisis, USA
Roy Gulick - Weill Cornell Medical College, Cornell University, USA
Sally Hodder - University of Medicine and Dentistry, New Jersy, USA
King Holmes (co-chair) - Center for AIDS & STD, University of Washington, USA
Michel Kazatchkine (co-chair) - Ambassador in Charge of the Struggle Against HIV/AIDS, France
Dan Kuritzkes - Harvard Medical School, USA
Sandra Lehrman – NIAID, NIH, USA
Veronica Miller - Forum for Collaborative HIV Research, USA
Paolo Miotti - Office of AIDS Research, NIH, USA
James Rooney - Gilead Sciences, USA
Paul Volberding - University of California, San Francisco, USA