Clifford Siporin, the president of Greystone Pharmaceutical Consultants, a contract research organization (CRO) in Parkland, Fla., has a challenge. His company is tracking down 2,600 volunteers to test a cholesterol drug for a biotech client, and it's taking more time than he anticipated.
"The protocol says you have to have a serum cholesterol of 220 to 260 based on three lab tests over a three-month period, one test per month," says Siporin. "So a patient comes in with 223 on the first test, so he qualifies. The next test is 226, so he still qualifies, but the next month he's at 264, so you've got to throw him out. This delays the clinical trial. It's still ongoing."
Siporin is not alone. The biotechnology and pharmaceutical industries face a host of headaches and growing challenges when it comes to recruiting volunteers for clinical trials. Company protocols are increasingly complex and require ...
