Tuesday, August 2, 2011

The Changing Face of Research Studies

The migration of clinical trials overseas has raised concerns about the impact of globalization on the U.S. research enterprise. But according to Luc Truyen, M.D., Ph.D., Global Head of Clinical Development Operations at Johnson & Johnson Pharmaceutical Research Development, a more pressing issue looms here at home, where changing demographics will have significant implications for future research studies.

During a presentation at the 2011 AAHRPP Conference, Dr. Truyen looked ahead to mid-century, when white non-Hispanics will no longer be the majority, and more than 30% of U.S. residents will be of Hispanic origin. He encouraged attendees to start preparing now to engage a more diverse population of research participants and investigators.

Off-shore vs. U.S. trials
The past six years have seen a steady rise in the percentage of clinical trials sites outside the U.S. According to clinicaltrials.gov, there were 53,065 phase II and phase III sites worldwide in 2005, and 42.5% of them were located abroad. By 2010, the number of sites had increased to 62,438, and 51.8% were overseas.

The largest increase has been in the Asia/Pacific region, where the number of sites increased from 3,212, or 6% of total sites, in 2005 to 6,895, or 11%, in 2010. During that same period, the number of U.S. sites decreased from 30,501, or 57.5% of total sites, to 30,114, or 48.2%.

Instead of focusing on the U.S. decline, however, Dr. Truyen emphasized the opportunities that remain. “The overall volume has grown substantially,” he said, suggesting that conference attendees “think how you can be part of it.” He also reminded attendees that federal regulations—which require studies to be applicable to the U.S. population and medical practice—will help ensure that research studies continue to be conducted in this country.

Coming soon: a new social order at home
Census data point to a fundamental shift in the ethnic and racial composition of the U.S. in coming decades.

  • The number of U.S. residents of Hispanic origin will increase by more than 100% by 2050. Nearly one-third of U.S. residents, or 30.2%, will be of Hispanic descent.
  • The percentage of white non-Hispanics will decline from 64.7% to 46.3%.
  • Already, for the first time in U.S. history, more than half of children under age 2 are minorities.

These trends could present a greater challenge than overseas migration, Dr. Truyen said, especially if the U.S. research enterprise fails to keep pace with changing demographics.

An advantage and an opportunity
Accredited organizations have an advantage in preparing for these shifting demographics, in part because AAHRPP standards provide both framework and flexibility. The standards should prove invaluable in guiding, but not prescribing, efforts to ensure that research remains relevant and applicable despite societal changes.

For example, standards require: 
  • Accredited organizations to take steps to enhance understanding of research by participants, prospective participants, and the community as a whole.
  • IRBs to include at least one member whose perspective reflects that of participants/the community.
  • Informed consent practices to ensure that participants genuinely understand the nature and potential risks of the research, and that their participation truly is voluntary.
  • Researchers to be qualified and demonstrate cultural competence, as necessary. 

As U.S. Hispanic populations increase, accredited organizations can remain in compliance by seizing opportunities to incorporate cultural diversity in staffing, participant recruitment, document development, and research design. Over time, this diversification should result in larger, more representative sample groups and more relevant data.

Organizations that serve more diverse communities will be the first to face pressure to reflect societal changes, and some already are taking steps to adapt. Ultimately, however, the research enterprise as a whole must commit to anticipating and reflecting a more multicultural U.S. It’s only fitting that accredited organizations take the lead and, in the process, improve the value of research and its benefit to society.

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