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 […]

Change is in the Air: Part V

This is the fifth installment in the series on changes coming to the clinical research enterprise from John Neal, CPA, BS, CRSP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees Prediction 5: Attention will turn more toward prevention, rather than cures. To be fair, rarely is there truly a […]

Change is in the Air: Part IV

This is the fourth installment in a series on changes coming to the clinical research enterprise from John Neal, CPA, BS, CRSP, founder and CEO of PCRS Network, LLC, and member of the ACRP Board of Trustees. Prediction 4: Fewer Principal Investigators will be needed in the future. Following my first three posts predicting that: […]