Congress Center Basel

Clinical Trials Ready to Embrace the IoE?

By Richard Strobridge

The Internet of Everything (IoE) is having an enormous impact. With Gartner listing the IoE as one of the top ten strategic...

10th DIA China Annual Meeting

Beijing International Convention Center

FDA Oncology Center of Excellence Aims for Distinction in Product Review and Leadership in Drug Development

By Richard Pazdur, MD

The formation of the OCE has been a year-long process that grew out of former Vice President Joe Biden’s National Cancer...

DIA 2018 Global Annual Meeting

Boston Convention and Exhibition Center

Structured Risk Assessment for First-in-Human Studies

By Mattheus (Thijs) van Iersel, MD; Howard E. Greenberg, MD, MSE, MBA, FCP; Mary L. Westrick, PhD

We describe a structured risk assessment and risk mitigation process that is currently used to evaluate proposed first-in...

Benefit-Risk Management

Dorint An Der Messe Basel

Special Populations in Clinical Pharmacology Studies Evolving Challenges

By William B. Smith, MD; Harry Alcorn, PharmD

The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase...

Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies

By Gary L. Steinman, MSE; William B. Smith, MD; Mary L. Westrick, PhD; Howard E. Greenberg, MD

This paper summarizes a discussion that took place at the 52nd Annual DIA Meeting in Philadelphia, PA, on June 30, 2016...

Describing the Endpoint Consistency Across Protocols, Study Reports, Postings, and Publications

By Yeshi Mikyas, PhD

Endpoints are the cornerstone of clinical trial design and are the critical elements for evaluating the success of a clinical...