Navigating the Perils and Promise of Centralized Clinical Management

The leaders of institutions involved in the conduct of clinical research have the option of various models for managing their clinical research personnel. When considering a centralized or hybrid model for management of such professionals, experts advise that the organizational leaders must engage stakeholders early and often in the process, and build in flexibility to […]

Can Facebook-Fueled Trials Lessen Recruitment Burden on CRCs?

A Phase IV clinical trial deemed “successful” by the firm that provided patient outreach technology for it is the type of new trial that will make the job of a clinical researcher coordinator (CRC) more “meaningful,” according to Kai Langel, director of patient research and cofounder of eClinicalHealth Limited. The diabetes trial recruited all of […]

NIH Expects Multisite Research Trials to Stick with Single IRB

The National Institutes of Health (NIH) just issued a policy statement to the effect that it expects all sites participating in multisite studies funded by NIH and involving non-exempt human subjects research to use a single institutional review board (IRB) to conduct the ethics review to ensure the protection of participants. The stated policy, years […]

Diagnostics Key to Effective Alzheimer’s Clinical Trials

Nearly one-third of all subjects enrolled in Alzheimer's trials don't match the protocol because they don't actually have the disease, according to Dave Ricks, senior vice president and president with Lilly Bio-Medicines at Eli Lilly and Company. Weak diagnostics is one of the biggest problems, he added. "We need diagnostics before the symptoms appear," he […]

Pharmacist Involvement Key to Improving Clinical Trial Recruitment, Retention

More than 95% of respondents in a recent survey said they were more comfortable participating in a clinical trial knowing that a pharmacist was on call to answer questions, says Gerald Finken, a registered pharmacist since 1982. “A majority of patients have significant questions which, if not addressed in a timely manner, can adversely impact […]