ACRO aims to boost US and EU investigator trial participation

14-Jun-2010 - Last updated on 15-Jun-2010 at 11:27 GMT

The ACRO says greater regulatory harmonization, expansion of trial registries and clarification of liability issues are needed to address the “alarming” drop in number of investigators participating in trials in US and Europe

Association of Clinical Research (ACRO) spokesman John Lewis told Outsourcing-pharma that: “Between 2004 and 2007 the number of FDA-regulated investigators declined 5 per cent in the US and 6 per cent in Western Europe.

“These are the latest figures available but we expect the trend has continued, or accelerated, in the past three years. So, ACRO conducted to survey to uncover the reasons for, and barriers to, participation in the US and Western Europe.”

The survey, undertaken with the US Academy of Pharmaceutical Physicians and Investigators (APPI), quizzed 300 doctors in the US and Europe, both participating and non-participating, about a range of issues surrounding involvement in clinical trials.

One theme to emerge is the belief that the “current regulatory environment makes clinical trials difficult to manage.” This prompted ACRO to call for more cross border uniformity of the rules governing trials as Lewis explained.

“We think a good first step would be harmonization of regulations so that the same rules applied regardless of where in the world [it] was taking place, who was funding [it] or the setting [in which it was taking place].”

He added that, also from a regulatory perspective, broad application of International Conference of Harmonisation-Good Clinical Practices (ICH-GCP) standards should be the common theme.

Registry expansion

Lewis went on to suggest that improving the availability and utility of information on in-progress trials, through a collaborative expansion of the clinicaltrial.gov and EudraCT databases, would help attract more physician participation.

“This,” he explained “should be a combined effort of industry and government, with input from the patient and provider communities, to determine what information is needed to make clinicaltrials.gov and EudraCT more robust and useful for investigators, potential research participants and others.

“Ultimately the responsibility lies with the NIH in the US and the EMA in Europe but this should be a public-private effort to enhance the systems. ACRO plans to work on a detailed set of recommendations.”

Liability concerns differ

However, while concerns about participation were broadly similar on both sides of the Atlantic, the survey did show that US investigators think revenue generation is a more important reason for taking part in clinical research than their European counterparts.

“One factor [in this discrepancy],” Lewis suggested “is the higher cost structure of operating a medical practice in the US because of greater concerns over liability/malpractice lawsuits and the greater use of research staff in the US.

“88 per cent of US investigators reported having at least one research assistant on staff while only 51 per cent of investigators in Western Europe do. So there are additional cost components.

“Also, the medical culture and compensation structure for physicians is different in the US so there is a higher expectation for revenue.”

This clearly presents something of a problem for those wishing to attract greater participation among US investigators. One positive to emerge from the ACRO survey in this regard is that 73 per cent of non-participants surveyed had indicated "an interest in becoming an investigator."

The ACRO said that to make the most of the opportunity "this group...needs better access to information about clinical trials, a better understanding of the regulatory structure for conducting trials and further education about liability issues and compensation for participating in research."