National Academies Report Calls for Withdrawal of Common Rule

Congress and the Obama Administration still have time for a critical “course correction” by withdrawing the Notice of Proposed Rulemaking for the “Common Rule,” according to the final portion of a report issued by the National Academies of Sciences, Engineering, and Medicine on June 29. The chair of the committee that wrote the report, Larry […]

Change is in the Air: Part VI

This is the sixth installment in the series on changes coming to the clinical research enterprise that John Neal, CEO of PCRS Network, LLC,  began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.” Prediction 6: There will be fewer studies […]

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 […]