RSO News
March 2004

IS COMPETITIVE ENROLLMENT AN EFFECTIVE STRATEGY FOR SPONSORS? We are all too aware of the current practice of many sponsors to conduct clinical trials by competitive enrollment — many sites are initiated and the study continues until the total number of subjects reaches the predetermined goal, regardless of the distribution across sites. Under-enrollers are penalized because the large amount of effort required to initiate a study is not rewarded either financially or emotionally. Furthermore, data to support the effectiveness of pitting one site against another is lacking. Covance has found that quality often lacks among top enrollers. 80-90% of data queries derive from the top 25th percentile of enrollers, whereas the best quality data comes from middle enrollers. Competitive enrollment is particularly detrimental to subjects when a clinical trial requires a drug washout period before screening. These volunteers assume much of the risk of the study, but little of the benefit if a study is closed out before they can proceed to the active phase of a trial. Although a few sponsors are eager to establish better relationships with investigators, very few have made changes in how they conduct large, multicenter trials (source: CenterWatch 12/2003).

TELEMEDICINE AS A TOOL FOR CLINICAL TRIALS? The Fairview-University of Minnesota Telemedicine network provides videoconferencing-based patient care consultations to 13 sites in rural Minnesota serving a total population of over 340,000. Doctors at the University engage in real-time, two-way interactions with patients and can examine them with the assistance of a telemedicine nurse at the sites. Although videoconferencing is unlikely to take the place of all interactions between research subjects and investigators or coordinators, it is possible that this technology could reduce some traveling for research subjects. The network is willing to work with your project to recruit and/or follow up rural patients and to provide videoconferencing communications to interact both with rural physicians and patients involved in your study. To discuss how you might be able to utilize telemedicine for your clinical trial, contact Stuart Speedie, PhD at speed002@umn.edu or 612-624-4657.

AHC CLINICAL TRIALS WEBSITE. The AHC Clinical Trials website ( www.ahc.umn.edu/trials ) provides the public and sponsors with information about what types of trials are being done at the University. The website also provides a vehicle by which potential subjects may volunteer. This website lists trials from a database maintained by the AHC Office of Research (OOR). The PI activates the trial listing by selecting the trial status. Clinical trials not reviewed by the AHC OOR (those that are not being performed at Fairview Health Systems) may also be listed by University community members. Questions and comments should be directed to P. Michael Nordberg at ahcoor@umn.edu .