The rapid expansion of the trials sector in Asia, Africa and Central and Eastern Europe, the recent criticism of studies in India and the memory of Pfizer’s Trovan programme in Nigeria has led some to question if ethical and safety standards are being met in the developing world.
However, according to ACRO executive director Doug Peddicord these concerns are unfounded because “CROs are making sure quality and ethical standards remain consistent through out the world.”
The ACRO report, which was commissioned in response to falling US recruitment rates, found that, in general, good clinical practice (GCP) training provided by contract research organisations (CRO) in the developed world meets with standards applied elsewhere.
The report also found that, in addition to providing a boost for the local economy, the drug development process is faster when trials are conducted in a number of countries.
One piece of analysis suggested that, due to enrolment rates, Phase III cancer trials conducted simultaneously in the US and overseas are completed around three times as fast as those only carried out in the US, 1.9 years versus 5.8 years.
Problem of perception
Despite these findings Peddicord said that that there is a problem with perception about the quality of trials in the developing world.
He suggested that: “The public will never have confidence in trials conducted in emerging regions like Asia and Latin America unless we level the playing field with the US, Canada, Western Europe and Japan.
“If the entire world plays by the same rules and gets the same resources patients worldwide will benefit from life-saving drugs more quickly and more cost effectively,” he added.
The ACRO report can be obtained here.
This conclusion is similar those of a report by George Annas, chair of the department of health law, bioethics and human rights at the Boston University School of Public Health in the US.
Annas’ finding was that the increasingly globalised clinical trials sector calls for an internationally accepted set of safety and ethical rules that can be applied to all clinical development programmes.
Like the ACRO Annas also recommended that global regulatory agencies, like European Medicines Agency (EMEA) and the US Food and Drug Admi9nistration (FDA) be given the means to conduct foreign safety inspections