Clinical trials for HIV Treatments
A cure for HIV will be an essential part of ending the pandemic.
In the past three years, increasing scientific momentum has been evident in research aimed at curing HIV infection (Lehrman 2005; Richman 2009; Trono 2010; Palmer 2011). The remarkable case of “Berlin Patient” Timothy Brown—an HIV-positive American diagnosed with leukemia who appears to have been cured of HIV infection (Hütter 2009; Allers 2011; Hütter 2011)—has contributed to reinvigorating the scientific community to investigate the possibility of discovering and developing a safe, effective, feasible, and scalable HIV cure (Lewin 2011a, 2011b).
Among the signs of progress, researchers have contributed new insights into where and why HIV persists in the body even when powerful antiretroviral therapy has all but shut it down. Ultrasensitive tests can detect the virus at the level of a single copy of RNA. The first controlled trials of a class of drugs called histone deacetylase (HDAC) inhibitors that may roust HIV from its hiding places are underway, and other types of treatments designed to teach the immune system to either clear or control the virus on its own have been initiated. The National Institutes of Health (NIH) is now funding cure-related research specifically through three consortia funded by grants named after long-time AIDS activist Martin Delaney.
Now that a cure has been proved to be possible, the challenge has moved from encouraging researchers to take up cure-oriented studies to figuring out how to design and conduct those studies. What’s more, given that such trials are likely to confer risks to the HIV-positive people who participate in them, researchers, regulators, and activists must come together to ensure not only that participants are kept safe, but also that research can move forward quickly and confidently, even if the first trials do not produce positive results.
To address these objectives, four HIV research advocacy organizations—the AIDS Policy Project, the Foundation for AIDS Research (amfAR), Project Inform, and the Treatment Action Group (TAG)—convened a meeting in April 2011 bringing together academic researchers, government scientists, regulators, and community advocates to discuss the state of the field and to identify action steps that can be taken to both sustain and hasten the progress of cure-related research.
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
Does the European clinical trials directive really improve clinical trial approval time?
To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries regulated by EUCTD vs. EU countries regulated by local legislation and, second, to compare the duration of regulatory approval in Europe vs. the USA and Australia.