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International Clinical Trials

The Transatlantic Gap

A survey of clinical investigators has revealed significant differences between physicians in the US and Europe; John Lewis of the Association of Clinical Research Organizations (ACRO) reports

By now the trend is all too familiar: the number of physicians participating in clinical research is continuing to decline in the US and western Europe, while increasing at double-digit rates in Asia, Latin America and central/eastern Europe. This decline is especially troubling given that only an estimated four per cent of US physicians currently participate in research.

The internationalisation of clinical trials is not a bad thing; in fact, the Association of Clinical Research Organizations (ACRO) and its members support the development of a global clinical research infrastructure, with members routinely conducting research in more than 115 countries. Access to a global medical infrastructure and global population is critical to the conduct of research, and the ability to accelerate the drug development process. This is why ACRO members have invested hundreds of millions of dollars building research capacity in ‘developing’ and ‘emerging’ countries like India, China, Russia, South Korea and Singapore, as well as throughout Latin America, Africa and the Middle East.

But with a large pool of available physician investigators, the decline in participation in US and western Europe represents a missed opportunity, and an understanding of the underlying causes for the declining interest in research is key.

ACRO partnered with the Academy of Pharmaceutical Physicians and Investigators (APPI) and engaged Industry Standard Research to conduct a survey of more than 300 physician investigators, non-investigators and former investigators to determine potential policy recommendations to encourage participation.

FINANCIAL INCENTIVE

The findings reflect cultural, economic and political differences between the US and Europe; some expected, some not. The most significant difference between US and European investigators was found in their motivation for participating in clinical trials. Both groups were similarly interested in ‘participating in the advancement of science’ and ‘bringing new therapies to help patients’, but the US investigators placed a much higher premium on generating additional revenue. In the US, 68 per cent of investigators said this was a ‘very important’ factor in their participation, compared to only 26 per cent of European physicians.

European and US investigators in the survey had similar levels of experience – approximately 13 years – but US physicians typically conducted about twice as many trials – 19 versus nine on average over the past 24 months. The higher level of activity, combined with generally higher per patient fees, translated into a significantly higher level of compensation for US investigators. On a per patient basis, US investigators reported receiving a median payment of $3,500 while the fee was $2,000 in Europe. The median income from clinical trials for a US investigator was $175,000 versus $25,000 in Europe.

It is important to consider, however, that US investigators in all likelihood face a much higher cost structure to manage their practices. For instance, 88 per cent of US investigators reported having at least one research coordinator on staff compared to 51 per cent in Europe. In a related finding, 25 per cent of European physicians identified ‘staff related issues’ as a major area for additional investment to encourage more research participation – by far the most critical issue cited. By way of comparison, only six per cent of US physicians identified staff issues as an area in need of major improvement or investment. US physicians cited ‘education’ as the area most in need of improvement.

US investigators also may have invested more in training. While similar percentages of US and European investigators have received GCP training – 75 per cent and 67 per cent, respectively – 72 per cent of US investigators reported receiving specific clinical research training, compared to 50 per cent in Europe.

LIABILITY

Concerns over liability are far greater in the US, according to the survey, illustrating another area where the cost structure of a research practice may be higher because of increased compliance activities and possibly malpractice insurance costs. Double the number of US investigators cited ‘liability concerns’ as a deterrent to participating in clinical trials, with 42 per cent agreeing liability is a major factor. By contrast, only 20 per cent of European investigators said liability concerns were a major barrier to participation. Interestingly, when weighing the impact on participation of issues such as conflict of interest rules and regulatory constraints, there were no meaningful differences of opinion between US and European investigators. So, clearly, the US must address these liability concerns to encourage more physicians to participate in research.

INSURANCE

Another issue that affects clinical trial participation in the US, though not directly physician participation, is a patient’s access to healthcare insurance. Twenty-six per cent of US investigators said this was a major concern for potential study participants, while only eight per cent of European investigators saw concern over insurance coverage as a major impediment to participation.

The US healthcare reform legislation signed into law in March 2010 – The Patient Protection and Affordable Care Act – will remedy this situation to a great degree by making insurance coverage available to approximately 30 million uninsured Americans. There was also a little known provision in the legislation that guarantees that individuals cannot have their coverage for routine care jeopardised by their participation in a clinical trial, but this provision does not take full effect until 2014.

The shared barriers to participation include: patient recruitment; time constraints; regulatory challenges; financial issues; and ease of access to information about trials.

Survey details

ACRO, working with the Academy of Pharmaceutical Physicians and Investigators, conducted the survey on 210 active investigators that split approximately evenly between the US and western Europe. The survey was conducted in April/May 2010. The profile that emerged was as follows:
  • Eighty-five per cent were currently working as investigators in a clinical trial; the other 15 per cent had been doing so in the last 12 months
  • One third of investigators came from academic medical centres, private practice and hospitals respectively
  • Investigators had 13 years’ experience on average
  • Investigators had conducted 13 studies in the past 24 months, on average
  • Seventy per cent of investigators were GCP trained
  • Sixty-eight per cent of investigators had one or more research staff members in the team (88 per cent US; 51 per cent Europe)
  • Two thirds of investigators considered research a ‘significant’ or ‘primary’ part of their practice; 1/3 adjunct
  • Eighty-five per cent of investigators used EDC
  • The average income of investigators per patient was $3,950 ($5,300 US; $3,100 Europe)

CONCLUSION

Based on these survey findings, ACRO is making a series of policy recommendations, which consider educational efforts to promote physician participation in research and is undertaking further research to explore some of these topics in greater detail. Some of these efforts are focused on the US, such as medical liability reform and guaranteeing insurance coverage for research participants. To date, investigator concerns over the conflict of interest rules and financial disclosures have been somewhat more prevalent in the US, but these are emerging issues in Europe and it is important to work with regulators to strike a balance to ensure integrity in the research process without stifling innovation.

Two other issues, however, are more universal. One of the major regulatory barriers to physician participation in research is a lack of consistency of regulations among countries and, in some instances, the application of differing regulations based on the sponsor of the research – industry or government – and the settings in which the research takes place – academic medical centre, private practice or hospital. Ideally, the same regulations should apply regardless of where in the world the research is being conducted, and who the sponsor of the studies is. Not only would this ease the burden on investigators, but it would also ensure the highest level of patient protection.

Finally, regarding access to information, ACRO is calling for the expansion and enhancement of clinicaltrials.gov in the US and the EudraCT system in the EU to make information about ongoing clinical trials more accessible to investigators, potential research participants and others. ACRO plans to gather ideas from investigators, research sponsors and CROs to provide a specific, comprehensive set of recommendations for improving these critical online clearing houses.

Working together, research sponsors, CROs and investigators can help break down these barriers to participation in research and help drive a healthy environment for medical innovation in the US and western Europe.


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John Lewis is Vice President of Public Affairs for the Association of Clinical Research Organizations, Washington DC, US. With 20 years of experience in public affairs and marketing, John joined ACRO in January 2009 after having previously consulted for the organisation. In his current position, he is responsible for ACRO’s public relations strategy, supports the organisation’s advocacy efforts, directs research and participates in coalition activities.

 

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