News

In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen describes how improving representation has changed trial design and site selection at Merck, where the hardest barriers remain, and what the industry will need to sustain meaningful progress over the next five years.

In today's ACT Brief, we explore how Let's Talk Trials addresses clinical trial awareness gaps, why participant readiness matters more than digital tools alone, and FDA's increasing scrutiny of AI use in regulatory and quality processes.

Participant adherence depends on readiness—a combination of knowledge, calibrated confidence, and real-world mastery—not simply on digital tools, reminders, or education, which are forms of exposure rather than preparation for sustained performance.

In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen explains how Let's Talk Trials was designed to address gaps in clinical trial awareness and access, what differentiates it from earlier efforts, and how trust sits at the center of the initiative's approach.

In today's ACT Brief, we explore how diversity is embedded across trial planning at Merck, integration of patient-reported and wearable-derived outcome measures, and AI applications in reducing clinical trial failure rates.

In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen discusses how diversity in clinical trials has become embedded in how Merck designs and executes its studies, and what accountability looks like internally across trial planning and community engagement.

The deal combines patient-reported outcomes with wearable-derived sensor data under a single provider, aiming to simplify multimodal evidence generation for clinical trial sponsors.

In today's ACT Brief, we examine leadership instability and regulatory uncertainty during Makary's FDA tenure, how lived experience shapes pediatric trial design and performance, and Eli Lilly's weight loss maintenance data for obesity therapies.

Pediatric trial participation shapes children's and caregivers' long-term psychological outcomes, yet protocol design often overlooks experience as a variable affecting recruitment, retention, and data integrity—a gap increasingly recognized by regulators and quality standards

In today's ACT Brief, we examine cost models for imaging infrastructure in clinical trials, how community relationships improve protocol design and site placement, and FDA leadership changes.

As imaging-heavy clinical trials grow more complex and globally distributed, sponsors are increasingly re-evaluating traditional infrastructure models, with cloud-native platforms showing potential to reduce operational burden, accelerate site activation, improve imaging quality oversight, and lower total trial costs.

In this video interview, Del Smith, PhD, CEO and co-founder of Acclinate, explains how deep community relationships generate insights that improve protocol design, endpoint selection, and site placement, while building an on-ramp that compounds in value across future studies.

In today's ACT Brief, we examine how protocol design decisions have become strategic business choices with outsized consequences for smaller companies, what clinical research sites need to compete and deliver, and leadership changes at the FDA.

From payment delays and feasibility misalignment to technology burden and AI adoption, clinical research sites are navigating a convergence of pressures that increasingly determine who sponsors work with and how well trials perform.

In this Q&A, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, discusses how clinical trial design has become a strategic business decision—and why small and midsize companies bear the greatest consequences when those decisions go wrong.

In today's ACT Brief, we examine CRIO and Medidata's partnership on seamless clinical trial data flow, Tufts CSDD findings on direct-to-patient site enrollment and diversity outcomes, and TransCelerate's work with FDA on selective safety data collection for pragmatic trials.

A new summary report from a joint tabletop exercise outlines how selective safety data collection approaches can be applied in practice, supporting broader adoption of pragmatic trial designs.

Limited evidence surrounds direct-to-patient clinical trial site models, despite growing literature showing that decentralized approaches can improve patient access, enrollment performance, and operational efficiency while reducing participant burden.

In this episode of the Applied Clinical Trials Podcast, Jonathan Andrus, co-CEO, CRIO, and Samir Jain, vice president of product management, healthcare data interoperability and EHR solutions, Medidata, discuss how their new partnership is enabling seamless data flow between eSource and enterprise platforms to reduce site burden and improve data quality across global clinical trials.

A global phase 3 study found that Moderna’s investigational mRNA-1010 influenza vaccine reduced RT-PCR–confirmed influenza-like illness more effectively than standard-dose vaccines in adults aged 50 years and older.

Incyte reports sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis, supporting growing interest in nonsteroidal topical therapies for long-term disease control.

LUCENT-3 trial open-label extension data show 63.5% of adults with ulcerative colitis administered mirikizumab (Omvoh) who achieved disease clearance at one year maintained composite disease clearance through four years of treatment.

Guselkumab (Tremfya) showed higher 24-week fistula remission than placebo in adults with perianal fistulizing Crohn disease.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

Early integration of clinical, operational, and patient-level insights during trial development can help close the gap between evidence generation and commercial performance, improving alignment between product value and real-world adoption.

FDA clears Cellenkos’ IND for CK0802, enabling a mid-stage trial in steroid-refractory GVHD.

In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, moves past the buzzwords to describe what supply chain resilience means in practice, and why continuity may now deserve to sit above compliance in a sponsor's order of priorities.

Execution instability often originates in strategy timing rather than study conduct, which sponsors can correct by integrating execution oversight expertise earlier in development decisions.