Where Are All the Patients?

Where Are All the Patients?

It’s no secret that patient enrollment is one of clinical research’s biggest hurdles. According to an analysis of trials listed, 55% of terminated trials were ended because of low patient enrollment. The analysis also reported that Phase III and Phase IV trials have an enrollment efficiency of less than 40%. Yet another analysis found more than 80% of studies do not enroll on time, often leading to a study extension or additional research sites.
The problem isn’t just enrollment, it’s also the enrollment of diverse patients. Racial and ethnic minorities, specifically Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native…

Continue Reading
What Is PHI, and How Can Healthcare Organizations Keep It Secure?

What Is PHI, and How Can Healthcare Organizations Keep It Secure?

What Is Protected Health Information?According to UC Berkeley’s Human Research Protection Program, PHI includes any information found in medical records or clinical data sets that can be used to identify an individual. In addition, this information must have been collected, used or disclosed while providing a healthcare service. PHI can be used during the diagnosis or treatment of a patient or in clinical research processes.
The HIPAA Privacy Rule and Security Rule require the protection of identifiable health information, such as:
Information collected by doctors, nurses and other healthcare providers in the medical record
Conversations between doctors and other healthcare providers about a patient’s…

Continue Reading