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Wednesday 26th October 2016

HIV trials face obstacles

10th March 2008

Scientists are warning that developing countries are facing significant challenges to their attempts to run clinical trials on HIV prevention strategies.


Experts say that African countries in particular face unpaid and overburdened ethics committees, delays in obtaining ethical approval, and political pressure to halt trials.

Salim Abdool Karim, director of the Centre for the AIDS Programme of Research in South Africa (CAPRISA), gave the example of his country's health minister calling for a halt to all HIV prevention trials in November 2007.

The ministerial intervention came after pharmaceutical giant Merck announced it would halt all further phase II trials of an anti-HIV vaccine because it was found to be ineffective.

Karim told an international microbicides conference in the Indian capital that such decisions should be made on a sound scientific and ethical basis, not for political reasons.

He said motivation was also a problem among trial volunteers, some of whom were participating for reimbursements, with adherence to study guidelines a major problem in some trials.

This was particularly true of women enrolling in trials for microbicides — vaginal anti-HIV gels or creams to prevent infection.

And in African multicentre trials, researchers often had to deal with inconsistent research standards, and trial regulators who were often inadequately equipped to address the technical aspects of complex trials, Karim added.

Indian experts say the country suffers from a lack of trained clinical researchers, poor laboratory infrastructure and pre-clinical screening and toxicology capabilities.

According to Nirmal Kumar Ganguly, advisor for the newly-announced Indian Translational Health Science and Technology Institute, cautioned that India also faces several challenges in anti-HIV clinical trials, despite the recent hype surrounding the country's emergence as a hub of clinical trials research.

While India boasts relatively well-equipped research institutes engaged in national and international collaborations, a large "at risk" population, and low cost of trials, further investments are still needed, he added.

There were unresolved ethical and intellectual property issues surrounding clinical trials that needed addressing, and clarification was needed with regard to the approval process for research with foreign institutes.

Roger Detels, professor at the epidemiology faculty at the University of California, Los Angeles, cited the absence of sound surveillance data to track infection trends as a key obstacle to microbicide research in developing countries.

Clinical trials, according to Detels, should be designed to address access by marginalised and high-risk groups, early education for trial participants, community involvement, and reducing cultural barriers.

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