The Association of Clinical Research Organizations (ACRO) provides an active voice for the global CRO industry by representing companies whose focus is clinical research., and offering specialized services that are integral to the development of drugs, biologics and medical devices. By maintaining the goal of improving the quality, efficiency and safety of biomedical research, ACRO’s member companies have a significant impact in the medical industry with approximately 70,000 employed professionals’ worldwide and more than 9,000 clinical trials being conducted annually involving nearly two million participants in 115 countries.
Recently, ACRO in a partnership with the Academy of Pharmaceutical Physicians and Investigators (APPI), 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, and the results of their survey were announced yesterday at the 46th Drug Information Association (DIA) annual meeting.
According to their press release, the survey explored the decline in physician participation in clinical research across the United States and Western European markets. Their findings show that 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.”
Discussing these results, Doug Peddicord, Ph.D., ACRO’s Executive Director, called the “decrease in investigators’ participation alarming, especially when both the U.S. and Western Europe have a large pool of trained physicians who could help drive medical innovation.”
The study surveyed 210 active investigators and 98 non-investigators between April/May 2010, and was split approximately evenly between the United States and Western Europe. The profile of investigator respondents that emerged is as follows:
85% currently participating in a clinical trial; 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)
For ACRO, these 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.” To boost physician participation in clinical research in both the U.S. and Western Europe, ACRO made several policy recommendations including:
Harmonize regulations governing clinical research across global markets, including expansion of industry standards to cover academic and federally funded research.
Address current, former and non-investigators’ concerns and misconceptions about liability issues surrounding clinical research.
Balance and standardize approach around conflict of interest and financial disclosure issues.
Expand and improve online access to information about clinical research opportunities for current and potential investigators; and
Guarantee health insurance for clinical trial participants to increase enrollment of eligible subjects.
One of the key concerns was 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.” Specifically, respondents were concerned about “medical liability, conflict of interest rules and mandates that physicians disclose financial relationships with drug industry partners.”
In addressing these concerns and to help reduce this as a barrier to physician participation, ACRO recommended “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.” They also recommended that policymakers revisit the liability/malpractice laws to encourage physician participation in research.
Another finding from the survey showed that “roughly half of respondents believe that a more comprehensive online marketplace or clearinghouse about research opportunities would help to increase physician participation,” since a lack of standardized information about research opportunities deters eligible physicians from participation in research. As a result, ACRO suggested 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.”
One major difference between U.S. and Western European investigators the study found is their motivation for participating in clinical trials. While both groups were similarly interested in “participating in the advancement of science” and “bringing new therapies to help patients,” “U.S. investigators placed a higher premium on generating additional revenue.” In fact, “68 percent of investigators said this was a “very important” factor in their participation compared to only 26 percent of Western European physicians.”
Some of the reasons for this difference are that U.S. investigators “likely face higher operating costs to manage their research activities.” In fact, “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.” Also contributing to a higher cost structure to conduct research is that “U.S. investigators show higher levels of concern over issues such as liability and insurance coverage for participants.
With regards to non-investigators, ACRO was “heartened to see so much interest in research from physicians who are not currently investigators, with “73 percent indicating an interest in becoming an investigator.” From these findings, ACRO acknowledged the need as an industry to “reach out and educate physicians about the many benefits of adding a research component to their medical practices. This also means giving physicians “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.”
In measuring patients’ participation in clinical research, 26% of U.S. investigators cited that lack of access to health insurance was a major deterrent of patient participation in clinical research while only 8% of European investigators saw a lack of health insurance as a barrier to patient participation. Optimistically, some believe that the Patient Protection and Affordable Care Act “will remedy this situation by making insurance coverage available to approximately 30 million uninsured Americans.” Others point to 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.
Accordingly, ACRO’s study shows that “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.” What the U.S. and Western Europe need instead is a “harmonized approach to the regulation of research that will help to encourage many eligible physicians or former investigators to engage in clinical trials that will help foster advancements in drug development and clinical research.”
Such an approach will lead to increased medical innovation and discoveries of new treatments and therapies that will ultimately benefit patients in need of new drugs and therapies.