TOO FEW CLINICAL INVESTIGATORS. CenterWatch predicts a 15% shortfall in the number of clinical investigators by 2005. Estimating a requirement for 56,000 principal investigators (PIs) to meet drug development demand, only 48,000 PIs may be available. Although the number of active PIs (those with an active FDA Form 1572 on file) has been increasing by 7% annually, up to one third of PIs will discontinue involvement in clinical trials in a subsequent year. The median age of PIs is 51 years, two years younger than in 1995. However, only one-quarter of PIs have more than five years experience and 63% are new to the field this year. Fifty-six percent of PIs are community- rather than academic-based. The average PI is participating in 1.8 trials concurrently.
This analysis suggests continued opportunities for clinical investigators. Inexperienced investigators or those seeking assistance in increasing their participation in clinical trials should contact the RSO.
 

CERTIFICATION FOR CLINICAL INVESTIGATORS ?. Here’s a development to watch. The Association for Clinical Research Professionals (ACRP), which has long held training programs and provided a certification program for clinical research coordinators and clinical research associates, is now targeting clinical investigators. ACRP has developed a Good Clinical Practices for Clinical Investigators training program, which qualifies for CME credit and will be presented at the ACRP Annual Meeting at the end of this month (www.acrpnet.org). ACRP is planning for this to be the first step toward “eventual certification of clinical investigators worldwide.”
 

PRIVACY ISSUES FOR THIRD PARTIES IN CLINICAL RESEARCH. Should a study subject, after giving consent, be permitted to give investigators familial information without consent of those family members? Family history is valuable information for many studies concerned with genetic influences on health and disease. Yet sensitive information about family members (examples include drug and alcohol histories, mental health histories) is potentially damaging if revealed. Therefore, the need to acquire such information must be considered in the overall discussion of risks and benefits of a clinical trial. This is yet another sensitive area that IRBs must address. Lana Skirboll, director of the NIH Office of Science Policy calls this “the world’s most impossible issue.”  (sources- L.A. Times and AAMC)
 

RECRUITMENT FOR DIABETES STUDY. Investigators here are seeking subjects for the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study sponsored by the NIH. Persons with Type 2 diabetes will participate in a study designed to learn how to best reduce the risks of heart attack and stroke. Contact Mike Mech at 624-6101 or mechx003@umn.edu for information.
 

GENERAL CLINICAL RESEARCH CENTER APPLICATIONS. The GCRC has revised its application form for GCRC protocols. The new form can be obtained at www.gcrc.med.umn.edu. A resource for obtaining demographic data for various diseases is available at www.medicine.uiowa.edu/gcrc/diseases/diseases.htm.