A new report released last week by the Association of Clinical Research Organizations (ACRO) says clinical trials conducted in the developing world not only match the quality and safety standards of those conducted in the developed world but they also improve the global drug development process.
The study, conducted by VOI Consulting in Ft. Lauderdale, Fla., was initiated by ACRO as a result of recent concern around the quality, safety and ethical standards of the growing clinical trial industry in developing countries. VOI prepared the report based on a review of 121 existing secondary research sources, such as peer-reviewed journals, trade journals, newspapers, U.S. Food and Drug Administration (FDA) inspections and regulatory reports.
Clinical trial activity in emerging markets has increased significantly in the past decade as drug sponsors seek to boost patient enrollment and reduce drug development time and costs. ACRO members conducted more than 9,000 clinical trials in 115 countries last year. While ACRO could not provide data on how these numbers have grown over the past several years, ACRO’s vice president of public affairs John Lewis estimated that, five years ago, ACRO members conducted trials in only 60 to 70 countries.
The 115 [countries] was, for us, kind of an eye-popping number,” Lewis said.
Though countries such as Nigeria and India have faced criticism around their clinical research practices, ACRO calls these “rare but well-publicized lapses” and says there are huge benefits to conducting clinical trials in the developing world.
According to ACRO’s report, global trials reduce drug development time by half while lowering costs and improve the local economies of host countries by bringing advanced technology and high-paying jobs to the area. The report goes on to say that trials in emerging countries are held to the same strict standards as those conducted in the U.S. and Western Europe.
“The CRO industry as a whole really does stand ready to work with the FDA and other regulators around the world around strengthening the scientific and research infrastructure and the regulatory oversight infrastructure,” said ACRO executive director Doug Peddicord. “We see that a very well regulated marketplace actually works better for sponsors, for CROs and for patients than a marketplace that doesn’t have adequate resources either on the research side or on the regulatory oversight side. We really do stand ready to work with FDA and with other regulators and other stakeholders in ensuring that Good Clinical Practice (GCP) and other standards are met worldwide.”
While ACRO’s new report speaks to the fact that clinical trial activity in emerging markets has certainly increased, Peddicord emphasized one of the reports major findings—that the majority of trials still take place in developed areas, including the U.S., Western Europe, Canada, Japan and Australia.
“The trend toward the internationalization of research is much more a good sign than a bad sign” in terms of enrolling patients and getting drugs to market, Peddicord said.
Although ACRO’s report speaks to the benefits of conducting clinical research worldwide, the organization does provide recommendations to ensure that quality and ethical standards are consistently met globally. Specifically, ACRO recommends that:
1.) The FDA have the necessary resources to conduct inspections on a global basis.
2.) All governments work to improve their countries’ clinical research infrastructure and to encourage patient participation.
3.) Overseas regulatory bodies recognize the advantages of globalized drug development.
4.) All participants in clinical research be afforded the same level of safety and ethical considerations as well as the same standard of care, including adherence to the GCP principles.