Regulatory Focus™ > News Articles > Researchers: Have Clinical Trial Regulation Progressed too Quickly in Developing Nations?

Researchers: Have Clinical Trial Regulation Progressed too Quickly in Developing Nations?

Posted 15 June 2012

"Two steps forward, one step back," laments an old proverb, describing the all-too-common tendency of progress to come paired with unexpected setbacks. Take, for instance, clinical trials regulations in emerging countries, write two researchers in the 12 June issue of the open source medical journal The Public Library of Science: Medicine (PLoS:M).

Many of the countries once lacked any semblance of a regulatory system, leaving trials to exist in a regulatory vacuum-if at all. So to encourage a more robust and well-monitored clinical trials system, some of these countries forged ahead with forming regulatory systems with which they could establish a foundation for improvements.

This has not been without consequence, write Trudie Lang of the Centre for Tropical Medicine at Oxford University and Sisira Siribaddana of the University of Rajarata.

"In developing countries it is our experience that external sponsors and their locally appointed contract research organisations (CROs) are often overly zealous in their interpretation of trial guidelines and apply a one-size-fits-all approach to trial coordination and monitoring, irrespective of the risk and complexity," the write the duo. "This perspective can lead to overly cumbersome trials and to burdening of research sites with administrative requests and site visits that are not necessary. In addition, steps and processes are introduced that can alter the expectations of ethics committees, funders, and reviewers and become perpetuated, irrespective of the real need."

In other words, recently-established and potentially vague guidelines are, in a sense, hurting patients and encouraging a less-than-efficient clinical trials enterprise. The authors provide several examples, including the use of Data Safety and Monitoring Committees even when they are not needed, unnecessary accreditation requirements, and lack of training requirements for clinical trials staff.

The Path Forward

"We are not suggesting in any way that processes and standards should be lower or different in developing countries, but we do feel that overly cautious application of regulations is common around the world- and that it creates a greater burden to research in resource-limited settings," explain the authors.

"[T]here is a call for making trial regulation less complicated and more readily adaptable to risk, and for having guidelines that are globally applicable and adaptable to all types of trial," they continue. "Such guidelines would be as easily applied to pragmatic trials of existing treatments or disease management questions as they would be for trials of new drugs and vaccines."

Because developing countries have needs and abilities distinct from those of more developed countries, these countries should be allowed to work with leeway sufficient to address their most pressing issues, the authors write. In Sri Lanka, explains Siribaddana, pragmatic clinical trials allowed a community to launch a local investigator-led trial to treat snakebites, which she called a "locally relevant question."

Bringing the clinical trials enterprise of developing countries back into the hands of local populations could have widespread benefits, conclude the authors.

"We feel that pre-trial community engagement, ongoing dialogue, and post-trial information giving are important to build and foster community trust for clinical research," explain Lang and Siribaddana. "Researchers in the developing world should come from the same or similar community and relative standard of living in which the research is being done."

"Not only would mean they have a sense of belonging to that community and the country, but the country and the community also would own and take pride in their researchers."

Read more:

PLoS - Clinical Trials Have Gone Global: Is This a Good Thing?


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