|Articles|August 1, 2016

CTTI Recommends New Vaccine Approaches

The Clinical Trials Transformation Initiative (CTTI) have released recommendations for hospital acquired and ventilator-associated bacterial pneumonia (HABP/VABP) as part of its antibacterial drug development program. The recommendations outline clinical trial approaches such as early enrollment strategies and streamlining the collection of safety data.

Read the full release here

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

October 14th, 2026

FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations

A new white paper and public engagement process outline the FDA’s commitment to building fit-for-purpose evidentiary standards, stronger patient voice integration, and greater regulatory predictability across rare disease drug development and review.

© putilov_denis - © putilov_denis - stock.adobe.com

October 14th, 2026

Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection

Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.

October 14th, 2026

ACT Brief: Design Drivers of Trial Representation, eSource-to-EDC Data Automation, and Roche's ALK7 Obesity License

In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.

October 13th, 2026

IgniteData and RealTime Partner to Streamline Clinical Data Transfer From eSource to Sponsor Systems

The partnership gives RealTime's network of more than 3,000 research sites access to the Archer platform for direct, automated data transfer from eSource to any sponsor electronic data capture system or data destination.

October 13th, 2026

The Biggest Remaining Barriers to High-Quality RWE Across Oncology Data Platforms

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, identify three persistent obstacles to consistent real-world evidence generation in oncology—inconsistent data capture, structural data limitations that modeling alone can't fix, and the need for earned generalizability through deliberate multi-site validation.

A case study of how an emerging biotech moved from targeted monitoring to full clinical operations and site management across multiple studies. Credit: Stock.Adobe.com/PHOTO4U

October 12th, 2026

Flexible Clinical Operations and Site Management Across a Diversified Biotech Portfolio: An Application of Quality by Design and Risk-Based Oversight

How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.

Representation gaps in clinical trials are built into protocol, eligibility, and site decisions, not just recruitment efforts. Credit: Stock.Adobe.com/KHAN VECTOR CO.

October 12th, 2026

Beyond Outreach: Structural Drivers of Representation in Clinical Trials

The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long before the first patient is screened.

October 12th, 2026

What a Practical Roadmap for FDA and EMA Quality Frameworks Actually Looks Like

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.

CTTI Recommends New Vaccine Approaches

Related to this article

Trending on Applied Clinical Trials Online

IgniteData and RealTime Partner to Streamline Clinical Data Transfer From eSource to Sponsor Systems

ACT Brief: Design Drivers of Trial Representation, eSource-to-EDC Data Automation, and Roche's ALK7 Obesity License

FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations

The Biggest Remaining Barriers to High-Quality RWE Across Oncology Data Platforms

Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection