| Dr Hans-Detlev Stahl at Clinpharm International GmbH, and Maria Sumner and Rob Nichols at Phase Forward Europe Ltd investigate the possibilities of optimising the management of clinical trials at Investigator Hub-SitesTM with electronic data capture
Central and Eastern Europe has become a region heavily populated with Investigator Hub-Sites (IHSs). The Hub-Site model (see Figure 1), traditionally encompasses a central investigative site with investigators and study nurses usually employed on a full-time basis and focusing exclusively on the conduct of clinical trials. Recruitment of patients is conducted through networks of general practitioners (GPs) and specialists in private practice, who use serial mailings on the letterheads of their private rooms to inform their patients of the option of participating in a clinical trial at the Hub-Site. Additionally, advertisements in the press raise public awareness for a particular study.
All study-specific activities, including informed consent, are usually performed by the investigator at the IHS. Electronic data capture (EDC) solutions are also incorporated into the IHS model, which allows sponsor companies and clinical research organisations (CROs) to outsource complete phase II/III studies to a single organisation. Each trial is undertaken by dedicated clinical staff trained in using this standardised EDC solution. This unique combination of innovative recruitment with modern technology sees both clinical and data management costs and timelines reduced. |
