[NEW DELHI] Developing countries face several challenges to conducting clinical trials on HIV prevention strategies, scientists have cautioned.
Africa is particularly vulnerable to political pressure to halt trials, unpaid and over-burdened ethics committees and delays in obtaining ethical approval, Salim Abdool Karim, director of the Centre for the AIDS Programme of Research in South Africa (CAPRISA), told a plenary session at an international microbicides conference in Delhi last week (25 February).
Karim cited South Africa's health minister calling for a halt to all HIV prevention trials in the country in November 2007 — following the drug company Merck's decision to stop further phase II trials on an anti-HIV vaccine that was found to be ineffective — as an example of political interference.
"It should not be a political issue, but one of good science and good ethics," he said.
Karim added that while many women enroll in trials for microbicides — vaginal anti-HIV gels or creams to prevent infection — for altruistic reasons, others enroll for reimbursements, often causing them to drop out or not adhere to the study guidelines.
He also pointed out that in African multicentre trials, researchers often have to deal with inconsistent research standards, and trial regulators are often "inadequately equipped to address technical aspects of complex trials".
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 (see Vaginal anti-HIV gel 'safe for regular use').
India's advantages include relatively well-equipped research institutes engaged in national and international collaborations, a large "at risk" population, and low cost of trials.
But the country still needs to improve its pool of trained clinical researchers, laboratory infrastructure, and capability in pre-clinical screening and toxicology studies, Ganguly said.
The approval process for research with foreign institutes is also unclear and India needs to resolve ethical and intellectual property issues surrounding clinical trials, he added.
A key challenge to microbicide research in developing countries is the absence of sound surveillance data to track infection trends, Roger Detels, professor at the epidemiology faculty at the University of California, Los Angeles, said.
He said clinical trials should be designed to address access by marginalised and high-risk groups, early education for trial participants, community involvement, and reducing cultural barriers.