As companies seek ways to bring their products to multiple markets, understanding those markets and their regulatory approval process is imperative. Choosing the most appropriate pathway can reduce the burden on both the sponsor and on the health authorities, and potentially expand access to more patients. One such pathway is the Access Consortium, which was formed in 2007 by four health authorities.
Studies of major depressive disorder require knowledge of its biology, the biomarkers that can be used as signals for efficacy, the optimal study design, and the availability of a study population that meets the protocol-specified inclusion and exclusion criteria.
Preventive antimicrobials are a promising solution to the antibiotic resistance problem, driven in part by recent advances in cell engineering technology and the important safety advantages of biologic drugs over their small-molecule cousins. However, not all of the barriers to wider adoption are scientific or biological—this novel therapeutic modality has important clinical, regulatory, and patient recruitment implications.
Just in time to help recognize Pride Month, ACRP’s Clinical Researcher journal is pleased to share the first details from the lead peer-reviewed article on “Improving Cardiovascular Research for Transgender and Gender Diverse Populations” from a trio of WCG IRB expert contributors to the June issue. The article bolsters the issue’s “Let’s Get Personal: Scaling Clinical Research Down to You and Me” theme as it joins several other contributed pieces focused on patient centricity and personalized or precision medicine topics.
ACRP has been recognized by the American Society of Association Executives (ASAE) with a 2024 Gold Circle Award in the Media/Public Relations category for its Clinical Trials Day Campaign, Together We Can.