FEATURED ARTICLES

• Making The Lives Of Patients And Research Sites Easier

  Most clinical trials overlook one crucial factor: giving sites and patients a voice in how studies are run. That’s starting to change—and the impact is significant.

• Europe Has A Platform For Driving More Flexible Clinical Trials: It's Time To Use It

  Despite recent setbacks, Europe possesses inherent strengths in clinical research, and a concerted effort is needed to transform its potential into a thriving and competitive environment.

• Top 10 Challenges And Solutions For Decentralized Clinical Trials

  Decentralized clinical trials are reshaping research, but what are the biggest roadblocks to their full potential? We delve into the top 10 challenges and the cutting-edge solutions emerging.

• Regulatory Opportunities For Decentralized Clinical Trials: Insights From The SHASTA Project

  Project SHASTA, a pioneering effort to measure the benefits of decentralized trial elements, reveals significant regulatory opportunities that could shape the future of clinical research.

• Developing Drugs For Rare Diseases: A New Approach To Generating Clinical Evidence

  For rare diseases, scientific breakthroughs often stall before reaching patients. A new approach to generating clinical evidence could change that trajectory.

• Unlocking Potential AI And ML In Pharmacovigilance

  Artificial intelligence (AI) and machine learning (ML) hold transformative potential in pharmacovigilance (PV), with the ability to enhance the efficiency, accuracy, and timeliness of drug safety monitoring.

• Data Distortions: When Statistics Can Lead Us Astray In Drug Safety

  Post-marketing signals and AE frequency comparisons need careful interpretation. Discover how confounding factors and misunderstood statistics often mislead drug safety professionals.

• Accelerated Approval As The New "Norm" In Gene Therapy For Rare Diseases

  Gene therapy has revolutionized treatment prospects for rare genetic disorders by enabling corrective or replacement strategies at the molecular level.

• Advancing The Implementation Of ICH E17

  Explore the ICH E17 guidelines that provide a harmonized framework for designing and conducting multiregional clinical trials (MRCTs) to meet the regulatory expectations of multiple regions.

• Mental Health Apps: Regulation And Validation Are Needed

  Explore a proposed digital ecosystem that would balance rigorous validation with the urgent need for accessible mental health solutions, transforming the landscape into a resource for global well-being.

• Responsible Use Of AI In Healthcare: Work In Progress

  Delve into the transformative role and potential benefits of Artificial Intelligence (AI) in healthcare and learn why it's crucial to carefully consider and plan for the responsible use of AI.

• 'Real' Evidence Generating Real Pre- And Post-Market Benefits

  Review the current and future applications of RWD/E in drug discovery, clinical research, regulatory review and approval, and its role in promoting health equity and patient and provider access.

• Bringing Clinical Research To The Patient Using Patient-Centric Tech

  By fostering daily interactions between patients and technology, these smart hubs offer a sustainable approach to ensuring the success and integrity of clinical trials in an evolving landscape of drug development.

• Solving The Puzzle Of Real-World Data/Evidence

  Gain insight from several industry experts on how real-world data can be used to advance clinical research and enhance the landscape of therapeutic product development.

• Pitfalls And Possibilities: EHRs To RWD Via EDC

  Consider DIA GCP & QA Community Chair Terry Katz’s perspective on repurposing and analyzing EHR data for clinical research.

• RWD/RWE In 2023: Regulatory Policy World Tour

  Learn about what the industry considers RWD/RWE priorities for the year, as well as current efforts being taken within each region around the globe.