Regulatory

The execution translation gap—the failure to convert identified problems into coordinated, timely action—costs millions per trial through delayed amendments, persistent deviations, and slow site activation, yet remains addressable through aligned accountability and proactive execution management.

In this Q&A, Jenna DiRito, PhD, COO and co-founder of Revalia Bio, discusses how earlier, human-relevant data is reshaping go/no-go decision-making in drug development and what a truly front-loaded workflow looks like in practice.

Agency outreach targets a compliance gap affecting thousands of registered trials, with nearly 30% of studies subject to mandatory reporting showing no results submitted to ClinicalTrials.gov.

In part 3 of this three-part series, behavioral science reveals that clinical trial diversity cannot be achieved through last-minute recruitment efforts, but requires designing protocols, sites, and enrollment strategies around the real barriers and needs of underrepresented communities from the outset.

Risk-based monitoring requires integrated data systems, validated analytics, and strong governance to work effectively across global trials, but sponsors face significant technical and operational challenges that demand strategic solutions and organizational alignment.

The administration's latest budget proposal seeks sweeping reductions to federal health research funding, including the elimination of several NIH institutes and centers.

Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, integration, and internal alignment across functional areas.

Vaccine developers can reduce participant burden and extend follow-up timelines by strategically combining traditional site visits with real-world data collection, but the choice depends on follow-up duration, data requirements, and the patient population being studied.

Moving beyond vendor evaluation to incentive design in Phase II/III rare and genetic disease trials.

New framework establishes scientific standards for alternative methodologies, signaling a regulatory shift toward human-centric data in preclinical drug development.

Public-private collaboration and structured evidence consolidation are emerging as critical enablers of regulatory-ready digital end points, helping standardize terminology, reduce duplication, and accelerate the integration of digital health technologies into clinical research and decision-making.

Draft guidance outlines a “plausible mechanism” pathway to support approval of highly targeted therapies when traditional trials are not feasible.

In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their organizations’ merger is advancing the use of real-world data to inform trial design, patient recruitment, and regulatory decision-making.

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more flexible, data-driven approaches that integrate prior knowledge, reduce sample size demands, and align with evolving FDA guidance to accelerate evidence generation.

Rising development costs, low success rates, and increasing trial complexity are reshaping the clinical trial project manager role, demanding stronger digital fluency, adaptive leadership, and expanded stakeholder coordination to deliver studies efficiently.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

Sylviane de Viron, data and knowledge manager at CluePoints, shares new data highlighting regional variations in clinical trial risks—and how proactive risk planning based on up-to-date data is needed to overcome them.

Jeremy Wyatt, CEO, Ametris, explains how digital endpoints improve trial sensitivity, patient centricity, and efficiency through continuous real-world data, and why early regulatory collaboration is essential to reducing adoption risk and establishing consistent validation standards across programs.

Webinar Date/Time: Thursday, March 12th, 2026 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.

Charlie Paterson, partner at PA Consulting, describes how FDA capacity constraints are creating uncertainty from initial submissions through late-stage approval, elongating timelines and influencing global development strategies.

Charlie Paterson, partner at PA Consulting, outlines how limited FDA guidance on innovative designs, decentralized models, and digital endpoints is forcing clinical operations teams to recalibrate expectations and minimize regulatory risk.