Rapid recruitment in emerging regions can overload sites; FDA

17-Aug-2011 - Last updated on 28-Sep-2021 at 09:12 GMT

Related tags Food and drug administration Fda

The US FDA has warned that rapid patient enrolment in emerging markets can overload sites that lack the staff to oversee data as it is generated.

Sponsors are conducting clinical trials oversees to benefit from faster patient recruitment but should be careful what they wish for, a medical officer at the US Food and Drug Administration (FDA) warns.

“In certain regions you’re going to see more subjects per site [and] you have to be prepared for that rapid enrolment”, Cynthia Kleppinger, medical officer, division of scientific investigations, at the FDA told Outsourcing-Pharma.

Clinical trial sites lacking the resources to handle large numbers of patients can be overwhelmed. Other emerging market problems discussed by Kleppinger include lack of infrastructure, such as the investigator that went without safety data for a month because the fax machine was broken.

Issues raised by Kleppinger will be among the topics discussed by leaders from Merck & Co, Novartis, Roche and more at an Outsourcing-Pharma conference next month. The event, Patient Recruitment Outsourcing, takes place in Boston, Massachusetts on September 26 and 27.

To find out more and sign up for the event click here.