Monday, April 17, 2006

CTN Best Practices Presents Hot Topics at ACC 2006
By Amanda McMillan

Initiated in 2004 as a n etwork of 38 U.S. hospitals specializing in cardiovascular research, Clinical Trials Networks Best Practices (CTNBP) will eventually expand to include several separate networks spanning research areas such as adolescent psychiatry, reproductive medicine, and tuberculosis. Its primary goals are to:

• Foster a collaborative network of networks of clinical research professionals, sites, and organizations
• Improve the conduct of clinical research by defining best practices
• Standardize information systems and other research tools
• Engage sites in taking new research ideas quickly from concept to completion

To promote this agenda, CTNBP hosted an investigator symposium titled “Hot Topics in Clinical Research” at the American College of Cardiology (ACC) annual meeting on March 11. The series of presentations and panel discussions was moderated by CTNBP principal investigator Robert Harrington, MD, of the DCRI. Distinguished speakers and panelists included Robert Jesse, MD, PhD, Veterans Administration; Kirkwood Adams, MD, UNC Medical Center; Robert Vranian, MD, Mary Washington Hospital in Fredericksburg, Virginia; Helen Zimmerman, Penn State Milton S. Hershey Medical Center; and Chris Granger, MD; Linda Davidson-Ray; Mary Ann Sellers; and Eric Velazquez, MD, all of the DCRI and Duke University Medical Center.

Bob Harrington opened the symposium with an overview of CTN Best Practices, outlining its aims, recent accomplishments, and future objectives. To learn more about the network, visit the CTNBP Web site (www.ctnbestpractices.org).

Chris Granger then presented an informative talk on biomarker and gene repositories, emphasizing the meaningful and groundbreaking information that can be derived from such databases—information that can, in turn, direct physicians in providing the most appropriate medical care to their patients. After noting the i ncreasing interest in genetics/proteomics studies, Dr. Granger highlighted some significant biomarkers already in common use, gave examples of existing database initiatives, and described plans for the Duke Biorepository. He concluded his talk with an informed discussion of the r egulatory and legal issues that surround and oftentimes impede the collection of the personal health information solicited by these repositories.

Linda Davidson-Ray followed up with a talk centering on the issue of minority recruitment of both patients and investigators for clinical trials. Because minorities continue to be underrepresented in trial populations, the usefulness of data harvested from studies is limited. To help correct this undesirable situation, Ms. Davidson-Ray identified a number of strategies for improving trial participation among minorities. She noted that the NIH has enacted a policy that requires inclusion of women and minorities in NIH-funded trials and discussed the various barriers to participation encountered by minority patients, such as distrust of the medical establishment and poor socioeconomic status. Similarly, she highlighted obstacles that must be overcome in order to promote the involvement of minority investigators in clinical research. The talk ended with a challenge to the audience to begin addressing these issues at their home institutions.

Concluding the symposium, Robert Jesse discussed researcher and industry relations, using as a springboard an example of the increasingly common practice of drug trial site recruitment in the Third World . Although the story Dr. Jesse related took place in India , industry enlistment of underpaid and ill-equipped physicians for pharmaceutical trials is a practice all-too-familiar to U.S. researchers, as well. He went on to outline various potential conflicts of interest for investigators and institutions, and discussed the disclosure policies of the FDA and the Department of Health and Human Services. Considerations that Institutional Review Boards (IRBs) must confront were also touched upon. Dr. Jesse wrapped up his presentation with a call to action for changes in the value/reward system that currently under-girds the clinical research system.

Each presentation was followed by a lively Q&A session presided over by the panel of experts on the topic at hand. Important questions were raised, and key issues were elucidated. This summer, look for an announcement when the symposium is posted on the CTN Best Practices Web site.