Andy Studna, Editor

Industry has urgent need for an objective system that evaluates the efficacy of AI tools in clinical settings.

Authors highlighted outsourcing and the impact of the COVID-19 pandemic in these CRO/sponsor articles from 2023.

Industry experts touched on patient needs, rare diseases, and gender analysis among other topics in these written Q&As.

Applied Clinical Trials sat down on-site with many KOLs at some of industry's largest gatherings in 2023 including SCOPE, DIA, and DPHARM.

Throughout 2023, guests of the Applied Clinical Trials podcast spoke on a number of topics including clinical research in rare disease areas, data, and artificial intelligence.

Authors in this area focused on increasing diversity in clinical trials through patient-first payment options and trial design.

Parents of children with cancer and limited health literacy were associated with lower comprehension of informed consent.

In an interview with ACT editor, Andy Studna, Hesterlee, Chief Research Officer at the Muscular Dystrophy Association discusses a new therapy for Duchenne Muscular Dystrophy, Vamorolone, and what sets it apart from other therapies in the market.

An evolving payer and commercial landscape post-COVID-19 pandemic, increasing regulatory complexity, and the discovery of new treatments with smaller patient populations are all factors impacting the research, development, and launch of new pharmaceutical products.

Women within underserved populations with an endometrial, ovarian, or cervical cancer diagnosis were found to be underrepresented in trials.

Recent study proposes consensus-based extension to the Consolidated Standards of Reporting Trials 2010 Statement for factorial trials.

Aligning best practices in eCOA and ePRO within today’s evolving technology ecosystem.

How the Medical Information Data Uses For AI Semantic Analysis tool is saving pharma valuable time and resources in identifying data points.

Research shows GenAI has greater potential for a more immediate impact than previous digital technologies implemented in healthcare.

Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences highlights how awareness and clinical innovation have transformed research in the HIV space.

Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design.

Results from decade-long analysis suggest great improvement is needed in the quality of control groups.

Increased use of laboratory-developed tests emphasizes inaccuracy and need for regulatory intervention.

Increased use of fentanyl underscores immediate need for better testing methods.

New research initiative will investigate the potential of zanidatamab as a monotherapy and in combination with other treatments for patients with different tumor types and stages.

Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.

New laws leave consumers unprotected against third parties accessing their genetic data.

Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.

Insightful sound bytes from KOLs attending SCOPE EUROPE 2023.

Interactive panel discussed the evolving area of data transfer and the usage of EHR-to-EDC.

Industry leaders gathered to address the current landscape of data collection in clinical trials.

In an interview at SCOPE Europe 2023 with Applied Clinical Trials Editor, Andy Studna, Tony Mikulaschek, VP, eCOA, IQVIA Technologies addresses what stakeholders should be thinking of in the data collection space moving forward.

In an interview at SCOPE Europe 2023 with Applied Clinical Trials Editor, Andy Studna, Tony Mikulaschek, VP, eCOA, IQVIA Technologies discusses how regulatory bodies are currently viewing the data collection space.

In an interview at SCOPE Europe 2023 with Applied Clinical Trials Editor, Andy Studna, Tony Mikulaschek, VP, eCOA, IQVIA Technologies discusses how eCOAs are being applied to clinical trials.

With so many new solutions and other technologies appearing in the clinical trials space, how are stakeholders choosing which ones are best for them and how are these advancements translating to the actual clinic?