ACRO unveils survey findings on decline in physician participation in clinical research

Today, the Association of Clinical Research Organizations (ACRO) unveiled findings from a groundbreaking survey exploring the decline in physician participation in clinical research across the United States and Western European markets at the 46^th Drug Information Association (DIA) annual meeting. Over the past decade, the number of physicians participating in clinical research has continued to decrease in the U.S. and countries in Western Europe while participation increased at double digit rates in Asia, Latin America and Central/Eastern Europe. In partnership with the Academy of Pharmaceutical Physicians and Investigators (APPI), ACRO conducted a survey of investigators, non-investigators and former investigators in the U.S. and Western Europe to uncover factors deterring physician participation in clinical research and to determine opportunities for improved involvement. The survey was administered by Industry Standard Research.

“A harmonized approach to the regulation of research will help to encourage many eligible physicians or former investigators to engage in clinical trials which will ultimately benefit patients in need of new drugs and therapies.”

"The decrease in investigators' participation is alarming, especially when both the U.S. and Western Europe have a large pool of trained physicians who could help drive medical innovation," said Doug Peddicord, Ph.D., ACRO's Executive Director. "The association supports steps to strengthen the clinical trials enterprise in all regions around the world. However, physicians in Western Europe and the U.S. represent an important and underutilized resource to help develop new therapies and treatments."

The ACRO survey results indicate that there are key similarities and differences concerning factors that deter physician involvement in clinical research across U.S. and Western Europe, especially concerning the regulatory environments in each country, physician liability standards and medical malpractice laws, the region's health care delivery system and ease of access to information about clinical research opportunities. Based on the research findings, detailed below, ACRO has made several policy recommendations that could boost physician participation in clinical research in both the U.S. and Western Europe, including:

"We were pleased to partner with ACRO on this important survey, as many of our members are involved in research, discovery and development of new treatments and therapies around the globe," said Jim Thomasell, Executive Director of APPI.

The Regulatory Landscape

The survey found that 70 percent of all respondents in both the U.S. and Western Europe believe that the current regulatory environment makes clinical trials difficult to manage - with little variation between U.S. and Western European investigators. This includes concerns around medical liability, conflict of interest rules and mandates that physicians disclose financial relationships with drug industry partners. To help reduce this as a barrier to physician participation, ACRO recommends increased standardization among regulators globally, regardless of sponsor or research setting, including widespread adherence to International Conference of Harmonisation-Good Clinical Practices (ICH-GCP) standards. ACRO also recommends that policymakers revisit the liability/malpractice laws to encourage physician participation in research.

"Complex regulations, laws and multiple governing bodies overseeing clinical research in both the U.S. and across Western Europe can be cumbersome and difficult to navigate, especially when companies and research institutions are operating across continents," Peddicord continued. "A harmonized approach to the regulation of research will help to encourage many eligible physicians or former investigators to engage in clinical trials which will ultimately benefit patients in need of new drugs and therapies."

Information about Opportunities

The survey also found that lack of standardized information about research opportunities deters eligible physicians from participation in research. Roughly half of respondents believe that a more comprehensive online marketplace or clearinghouse would help to increase physician participation. ACRO suggests expanding clinicaltrials.gov and EudraCT, the online databases in the U.S. and European Union respectively, to increase and streamline access to information about opportunities for current investigators and those not already involved.

Motivation for Participation

Additionally, a major difference between U.S. and Western European investigators is 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 U.S. investigators placed a higher premium on generating additional revenue. In the U.S. 68 percent of investigators said this was a "very important" factor in their participation compared to only 26 percent of Western European physicians. There are a number of potential factors for this difference. U.S. investigators likely face higher operating costs to manage their research activities. For instance, 88 percent of U.S. investigators reported having at least one research coordinator on staff, which is considered an expense of the research facility, as compared to 51 percent in Western Europe. U.S. investigators also show higher levels of concern over issues such as liability and insurance coverage for participants, which could also be factors contributing to a higher cost structure to conduct research.

Among non-investigators, the survey revealed a high level of openness to research with 73 percent indicating an interest in becoming an investigator. This group, however, 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.

"We are heartened to see so much interest in research from physicians who are not currently investigators. This indicates that we as an industry must do a better job of reaching out and educating physicians about the many benefits of adding a research component to their medical practices," Peddicord added.

Access to Health Care

The survey also asked respondents about patients' participation in clinical research in both the U.S. and Western Europe. Twenty-six percent of U.S. investigators cited that lack of access to health insurance was a major deterrent of patient participation in clinical research while only eight percent of European investigators saw a lack of health insurance as a barrier to patient participation.

The U.S. health care reform legislation signed into law in 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 was also a little known provision in the legislation that guarantees that individuals cannot have their coverage for routine care jeopardized by their participation in a clinical trial, but this provision does not take full effect until 2014. ACRO encourages early implementation of this policy.

ACRO continues to advocate on behalf of the CRO industry and aims to strengthen public understanding and confidence around clinical research. ACRO and its member are committed to working with policymakers in the U.S. and abroad to help foster advancements in drug development and clinical research to increase medical innovation and discoveries of new treatments and therapies.

Survey Details

ACRO, working with the Academy of Pharmaceutical Physicians and Investigators, conducted a survey of 210 active investigators and 98 non-investigators split approximately evenly between the United States and Western Europe. The survey was conducted in April/May 2010. The profile of investigator respondents that emerged is as follows:

• 85% currently participating in a clinical trial; other 15% had been within past 12 months
• 1/3 each from academic medical centers/private practice/hospitals
• 13 years experience on average
• Conducted 13 studies in past 24 months on average
• Average income earned per patient $3,950
• 70% trained in Good Clinical Practice (GCP)
• 68% have one or more research staff (88% U.S., 51% Europe)
• 2/3 consider research significant or primary part of practice; 1/3 adjunct
• 85% use Electronic Data Capture (EDC)