Globally harmonised regulations, tackling concerns about liability, standardised approaches to conflict of interest, better access to information online and guaranteed health insurance for participants are among the steps that need to be taken to boost physician participation in clinical research in the US and Western Europe, says the US-based Association of Clinical Research Organizations (ACRO).
A survey conducted by ACRO with the Academy of Pharmaceutical Physicians and Investigators (APPI) found, for example, that 70% of all respondents believe the current regulatory environment makes clinical trials difficult to manage, with little variation in response between US and Western European investigators.
Motivation factors differ considerably, though. US investigators placed a much higher premium on generating additional revenue, with 68% citing this as “very important” in driving participation compared with just 26% of physicians in Western Europe.
Findings from the survey exploring the reasons for declining physician participation in clinical research across the US and Europe were presented at the 46th Drug Information Association annual meeting in Washington, DC this week. Over the past decade, ACRO notes, the number of physicians taking part in clinical research has continued to fall in the US and Western European countries, while participation has grown at double-digit rates in Asia, Latin America and Central and Eastern Europe.
“The decrease in investigators’ participation is alarming, especially when both the US and Western Europe have a large pool of trained physicians who could help drive medical innovation,” comments Doug Peddicord, executive director of ACRO. “The association supports steps to strengthen the clinical trials enterprise in all regions around the world. However, physicians in Western Europe and the US represent an important and underutilised resource to help develop new therapies and treatments.”
The ACRO/APPI survey was administered by Industry Standard Research and conducted in April/May 2010. It took in 210 active investigators and 98 non-investigators, split more or less evenly between the US and Western Europe.
Liability concerns
The findings revealed key similarities and differences in the factors that deter physicians from participating in clinical research in the US and Europe, particularly in respect of national regulatory environments, physician liability standards and malpractice laws, healthcare delivery systems and ease of access to information about clinical research opportunities.
On the regulatory landscape, sticking points identified in the survey included concerns around medical liability, conflict of interest rules and mandates that physicians disclose financial relationships with drug industry partners.
To help lower these barriers, ACRO recommends increased standardisation among regulators worldwide, regardless of the research sponsor or setting and including widespread adherence to International Conference on Harmonisation Good Clinical Practice standards. The association also believes policymakers should revisit liability/malpractice laws to encourage physician participation in research.
“Complex regulations, laws and multiple governing bodies overseeing clinical research in both the US. and across Western Europe can be cumbersome and difficult to navigate, especially when companies and research institutions are operating across continents,” Peddicord observes.
The survey also found that lack of standardised information about research opportunities is a disincentive to participation by eligible physicians. Roughly half of the respondents said a more comprehensive online marketplace or clearing house would help to increase physician participation.
ACRO suggests expanding clinicaltrials.gov and EudraCT, the online databases on clinical studies already operating in the US and the EU respectively, to increase and streamline access to information about opportunities for current and prospective investigators.
The identified differences between US and Western European investigators in the financial motivation for clinical research involvement was despite both groups being similarly interested in “participating in the advancement of science” and “bringing new therapies to help patients”. According to ACRO, the heavier US emphasis on revenue generation could be down to a number of factors, such as the likelihood of US investigators facing higher operating costs to manage research activities.
For example, 88 percent of the US investigators reported having at least one research co-ordinator on their staff, “which is considered an expense of the research facility”, compared with 51% in Western Europe, ACRO notes. US investigators were also more concerned about issues such as liability and insurance coverage for participants, “which could also be factors contributing to a higher cost structure to conduct research”.
Patient participation
The survey further examined factors driving patient participation in clinical research in the US and Western Europe. Among the US investigators, 26% cited lack of access to health insurance as a major deterrent to patient participation, compared with only 8% of European investigators.
As ACRO points out, the healthcare reform legislation signed into law in the US last March (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 is also a little-known provision in the healthcare reform legislation guaranteeing that individuals cannot have coverage for routine care jeopardised by their participation in a clinical trial, the association adds. It encourages early implementation of this policy, as the provision in Patient Protection and Affordable Care Act does not take full effect until 2014.
