An Approach to a Benefit-Risk Framework

Recently, there has been a shift from qualitative assessments of drug safety toward a more quantitative approach. A quantitative framework is a method for arranging numerical data in a standardized format to assist in the decision-making process. Formalized evaluation of benefit and risk of harm is referred to as the benefit-risk framework (BRF), and has been structured in a variety of different ways. The lack of wide acceptance of a particular BRF underscores the significant challenges.

Clinical Trial Technology: A CRO’s Perspective

Legacy technologies are no longer fit-for-purpose, and we must follow the lead of other sectors like manufacturing and consumer packaged goods in adopting generative artificial intelligence and other technology and data advancements to support pain points around patient experience, data integrity, quality, and the supply chain.

The Art of Investigational Site Relationships with Sponsors/CROs

Study sponsors and contract research organizations (CROs) follow a methodical process to select appropriate investigational sites for study participation, and effective relationship development is key to transforming a preliminary meeting into a flourishing partnership. The first impression created during site selection will impact the course of the ensuing relationship, and this selection process must be conducted professionally at all costs.
Photograph of Susan Landis

Making Your Profession One of Your Happy Places

Wherever your happy place(s) may be, in terms of both your professional and private sides of life, your ongoing membership in and commitment to volunteer engagements with ACRP are a big part of what keeps the Association’s lifeblood happily flowing all year long. We thank you for making life better for your organizations, participants, and community at large through your dedication to excellence in our profession. To keep the momentum going, whether or not you can join in on the fun and learning at ACRP 2024 in Anaheim, we invite you to consider how you can be an agent of happiness in your clinical research setting the rest of the year.

Lessons Learned from Challenging Cases in Clinical Research Ethics

Challenging Cases in Clinical Research Ethics may not be a book you take to the beach for a light read, but if you have a role, or an interest, in how the complex ethical challenges that are an integral part of conducting clinical research are analyzed, it may be a good book for you. This is a reference book, a teaching tool, and, in some ways, a historical record.