FDA

Real-time AI-enabled decision-making only accelerates development when trials have coordinated operational infrastructure for randomization, supply management, and workflows capable of responding to new insights without disrupting execution or compliance.

As agentic AI, automated data harmonization, and real-time monitoring reshape clinical development, the organizations seeing meaningful results are those that have invested in unified data infrastructure and disciplined governance rather than cycling through pilots without the foundation to scale them.

New documents targeting performance status, washout periods, and laboratory value thresholds aim to close the gap between patients willing to participate in oncology trials and those who actually enroll.

In this Q&A, Gaynor Anders, chief delivery officer at Trialbee, discusses how the FDA's single pivotal trial shift is raising the stakes on patient recruitment, why the study-by-study model has persisted for so long, and what program-level recruitment actually requires from sponsors in terms of infrastructure, data sharing, and organizational change.

The agency's guidance addresses the unique challenges of studying compounds like psilocybin and MDMA, from functional unblinding to safety monitoring and abuse potential assessment.

In this Q&A, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses the collaborative work underway with FDA and CTTI to explore selective safety data collection as a model for de-risking trial design, reducing site and patient burden, and scaling pragmatic trial approaches across the industry.

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.

Clinical data security built into system architecture from the foundation, rather than layered on afterward, reduces regulatory risk and actually accelerates research by removing manual compliance burden and improving team confidence in data integrity.

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.

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.

From rising costs and regulatory uncertainty to persistent vaccine hesitancy, sponsors face mounting pressure to standardize operations, build community trust, and develop the behavioral capabilities needed to run vaccine trials effectively in a rapidly shifting environment.

The CNPV program has compressed drug review timelines to as little as one to two months for qualifying sponsors, but succeeding under that pressure requires a fundamental rethink of how development teams plan, communicate, and execute.

FDA Commissioner Marty Makary’s departure caps a turbulent tenure marked by leadership instability, industry pushback, and a series of regulatory controversies that complicated drug development for sponsors and CROs.

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

Early implementation of real-time clinical trial data sharing aims to reduce delays in safety signal detection and regulatory decision-making, with pilot program development underway.

In this Q&A, Mwango Kashoki, MD, MPH, SVP and global head of regulatory strategy at Parexel, breaks down the FDA's plausible mechanism framework and what it means for sponsors developing individualized therapies in ultra-rare disease settings.

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 this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, breaks down how the FDA evaluates substantial evidence of effectiveness for individualized therapies in ultra-rare conditions, and why that determination depends on the totality of mechanistic, biomarker, and clinical outcome data rather than trial numbers alone.

In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, explains how the plausible mechanism framework reshapes the development timeline for individualized therapies by allowing first-in-human studies to serve as pivotal trials and giving sponsors earlier clarity on the evidence needed for approval.

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.

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

In the first months of 2026, the FDA has moved on multiple fronts to modernize how drugs are developed, evaluated, and approved, signaling a broader regulatory shift toward flexibility, mechanism-based evidence, and human-centric science.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, discusses how regulatory trust-building and reimbursement reform are essential to making wearable devices a sustainable and widely adopted part of clinical care delivery.