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Clinical Trial Diversity Requires Community-Based Research Infrastructure, US FDA’s Woodcock Says

 
• By Sue Sutter

COVID-19 trials could have reached underserved populations better if research infrastructure was in place where people routinely get their health care, acting commissioner Janet Woodcock says; PhRMA is looking to establish a public-private partnership that would build a sustainable community-based infrastructure for clinical research.

Building infrastructure
Community health care settings require research infrastructure investment if they are to conduct clinical trials. • Source: Shutterstock

The COVID-19 pandemic has highlighted the need to build clinical research infrastructure in community settings to ensure speedy trial enrollment and adequate representation of diverse populations.

Expansion of the research enterprise beyond academic medical centers could get a big boost from the creation of a public-private...

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More from Clinical Trials

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

More from R&D

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.