Andy Studna, Senior Editor

The agency's complete response letter transparency initiative has been on hold since April following a pharma industry legal challenge, even as the FDA moves to codify the practice through formal rulemaking.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains why the industry's protocol-centric recruitment model has persisted so long and what a shift toward programmatic, relationship-driven patient engagement actually looks like in practice.

In today's ACT Brief, we examine how FDA's single pivotal trial shift raises recruitment and retention stakes, why FSP should be viewed as a configurable continuum rather than binary choice, and a new pegfilgrastim biosimilar completing a major G-CSF portfolio.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains how the FDA's shift toward single pivotal trials is raising the stakes for sponsors on recruitment quality, feasibility precision, diversity, and retention—and why sponsors now say they get one shot to get it right.

In today's ACT Brief, we examine AI-enabled systems medicine connecting fragmented clinical data, how behavioral readiness and trust drive enrollment more than eligibility criteria, and scaling concentrated AI strategy across a global pharmaceutical enterprise.

In today's ACT Brief, we examine how selective safety data collection could ease operational burden and address investigator shortages, why site-specific technology limits AI adoption, and how regulatory pressure and patent cliffs are reshaping R&D investment strategy.

In this Q&A, Liz Beatty, co-founder and chief strategy officer at Inato, discusses how real-time patient data is reducing non-enrolling sites, why sponsor-specific technology remains the biggest barrier to adoption, and what a shift toward cross-asset site partnerships could mean for enrollment efficiency.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, looks ahead to how simplification built through selective safety data collection could ease broader trial operations and help address a shrinking investigator pool.

In today's ACT Brief, we examine regulatory partnerships debunking pragmatic trial concerns, how ePRO protocols create informal patient exclusions, and why system design—not patient behavior—drives disengagement.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses how CTTI tabletop exercises are myth-busting perceived risk and why true progress requires partnership across regulators, sponsors, providers, and patients.

In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol failures occur during operational transition, and congressional investigation into pharmaceutical company trials in China.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, breaks down CTTI research showing 50 to 75% reductions in visits and assessments using selective safety data collection, and why mature assets make this approach safe to use.

In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing incentive program.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains how four jointly developed regulatory scenarios give sponsors a blueprint for adopting selective safety data collection with greater confidence and stronger agency alignment.

Regulators on both sides of the Atlantic have taken action against Tavneos after an FDA investigation found patient outcome data was altered and trial personnel were unblinded during the pivotal study that supported the drug's approval.

In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data security must be designed in rather than layered on, and how AI is reshaping CDMO workflows and asset value.

The FDA's launch of real-time clinical trial proof-of-concept studies signals a fundamental shift in regulatory oversight, one that most sponsors are not yet equipped to meet and that demands urgent investment in unified data infrastructure, quality-by-design practices, and protocol digitization.

In today's ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine infrastructure gaps in continuous data review, and report on EMA support for a new BTK inhibitor strategy.

In this Q&A, Raj Indupuri, CEO and co-founder of eClinical Solutions, discusses what the FDA's push toward continuous data review actually demands of sponsors operationally, why fragmented systems are the core obstacle, and how AI and real-world evidence fit into a more data-driven regulatory environment.

From real-time evidence generation to federated AI to site-level data integration, ACT spoke with seven experts at DIA 2026 on the trends and challenges defining clinical trial operations today.

In today's ACT Brief, we examine integrating site and sponsor data systems, a high-profile trial retraction over integrity concerns, and a new first-line breast cancer treatment.

A Phase III trial linking morning administration of immunochemotherapy to dramatically better survival outcomes in non-small cell lung cancer has been pulled over concerns about data integrity, protocol inconsistencies, and unexpected findings.

In this video interview following the 2026 DIA Global Annual Meeting, Jonathan Andrus, co-CEO of CRIO, explains why integrating site-level data systems with sponsor oversight has remained so difficult, what a central eSource model requires to work for all stakeholders, and why the industry needs to stop waiting for perfection and start taking the step.

In today's ACT Brief, we examine regulatory uncertainty and 2026 breakthroughs shaping clinical research, reimagining CRO contracting models for financial transparency, and Eli Lilly's acquisition strategy.

In this video interview, Marwan Fathallah, president and CEO of DIA Global, makes the case for ecosystem-wide leadership in a time of regulatory uncertainty and highlights the breakthroughs in obesity, healthcare AI, and cell and gene therapy that have most excited him in 2026.

In today's ACT Brief, we examine HHS coordinated effort to restore US clinical research leadership, two decades of rising protocol complexity, and data architecture frameworks for AI sustainability.

A coordinated department-wide initiative combines FDA regulatory reforms, NIH investments, and new agency programs to reduce development timelines and reverse a growing shift of clinical research overseas.

In today's ACT Brief, we examine a major CRO-tech partnership scaling agentic AI, operational challenges sites face with decentralized trials, and AI-driven CNS drug discovery collaboration.

In this video interview from the 2026 DIA Global Annual Meeting, Nick Scott of Biogen and Samantha Hadfield of Thermo Fisher Scientific, discuss where mixed outsourcing models deliver the greatest gains in efficiency and agility, and why a deliberate, partnership-first approach is what separates successful implementations from ones that struggle.

In this video interview from the 2026 DIA Global Annual Meeting, Joan Chambers, independent senior consultant at Tufts CSDD, examines the operational challenges sites face when implementing DCT components and makes the case that the industry is still in a learning phase—one the data will ultimately need to guide.