FEATURED ARTICLES

• A Framework For Improving Maternity Healthcare In The US (And Elsewhere)

  The U.S. has the highest maternal mortality rate among industrialized nations. For Black women, the odds are even worse. Here's why — and what can be done.

• 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.

• How To Build Partnerships For Sustainable Healthcare

  Effective partnerships are essential to address the multifaceted challenges of the healthcare sector, yet collaborative efforts often face persistent barriers.

• Operational Excellence In An International Clinical Research Site Network

  This case study highlights operational excellence within a global clinical trial for osteoporosis, underscoring the critical role of site networks in achieving research success.

• 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.

• The "Journey To Better Health" Mobile Education Exhibit

  An innovative educational outreach initiative has hit the road to spread awareness about clinical research and highlights the importance of diverse representation in clinical trials.

• 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.

• Bedside-To-Bench-To-Bedside Collaboration

  Explore how the partnerships between cutaneous T-cell lymphoma (CTCL) patients, physicians, and researchers is leading to advancements in diagnosing and managing this life-threatening disease.

• A New Pharmacovigilance Ecosystem: Automation, AI, And Continuous Improvement

  As Pharmacovigilance (PV) evolves into a proactive, value-driven discipline innovations like robotic process automation and artificial intelligence help improve efficiency and data utility.

• Regulatory Roundup: Insights From Global Town Halls At DIA 2024

  As regulators adapt to new challenges, including pandemics and the rise of advanced therapies, their commitment to innovation, collaboration, and patient safety remains paramount, shaping the future of global health.

• Remote Services And Technology - Regulatory Clarity For Investigators

  By focusing on updating regulatory frameworks, developing technical standards, and leveraging technology for compliance, see how the industry can ensure safely and ethically trial conduct.

• Making Global Reliance A Reality For Post-Approval Changes Of Medicines And Vaccines

  Discover how global stakeholders are working together to streamline regulatory processes and enhance transparency through reliance approaches in post-approval changes (PACs).

• Clinical Trials In Wartime: One Patient's Journey To Survival

  Discover the human stories behind the halted clinical trials in Ukraine and understand the broader impact on medical research and patient care.

• '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.

• My First Forty Years At DIA

  Following the simple logical flow we recommend for all Global Forum articles—What, So What, Now What—let’s delve into why DIA remains a cornerstone for professional growth and innovation in our field.

• Digitizing Protocol Design And Deploying AI To Save Time, Money

  Begin your journey to AI-driven clinical research by capturing high-quality electronic data, paving the way for transformative operations, deeper insights, and smarter protocols.

• Proposals From The DIA/Harvard-MIT CRS CGT Executive Roundtable

  Gain insight into the critical importance of proactive engagement, collaborative partnerships, and continuous education to navigate these challenges effectively.

• Patient And Public Involvement – Stranded On The Adoption Curve?

  By elucidating the barriers impeding progress on the PPI adoption curve and offering actionable insights, this article aims to catalyze renewed efforts toward harnessing the full potential of patient engagement in shaping the future of healthcare delivery.

• Globalization: The DNA Of DIA

  Listen to former DIA Board President Minnie Baylor-Henry’s special message to DIA members as part of DIA’s 60th Anniversary celebration in 2024.

• Cancer Treatment: Advances In The 20th And 21st Centuries

  This exploration not only illuminates the remarkable strides made in combating cancer but also underscores the pivotal role of cutting-edge technologies in shaping the trajectory of oncological care.

• 6 Decades Of Impact: DIA's Global Journey

  By embracing its foundational pillars, learn how DIA continues to address ongoing challenges in drug information and healthcare as it enters its seventh decade in the industry.

• 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.

• Why In The World Should You Come To San Diego?

  With over 180 sessions across 13 tracks and nine engaging learning formats, attendees will delve into emerging fields such as precision medicine, regulatory CMC, and product quality, and value-based access.

• 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.

• How Diversity, Innovation, And AI Are Accelerating Health

  To ensure technological innovations make a tangible impact in the real world, discover why it is imperative to cultivate an environment that is both receptive and prepared to embrace and integrate them.

• Solving The Rubik's Cube Part 3: Maintaining Human Touch

  Explore how the combination of tech innovations and the human touch could seamlessly align advancements in clinical research with the diverse needs of participants and caregivers.

• Solving The Rubik's Cube Part 2: Strategic Partnerships

  Learn how this collaborative approach ensures better patient experiences without overwhelming sites or diverting their focus from participants.

• Solving The Rubik's Cube Part 1: AI And Data Quality

  Learn why adopting AI-driven risk-based quality management will be essential in ensuring the accuracy of data from diverse sources.

• Embedding Inclusive Research Principles In Trial Design, Execution

  Get a comprehensive examination of the impact of a lack of diversity in public health, delving into the various barriers that historically marginalized populations encounter when attempting to participate in clinical research.

• Regulatory Pathways Supporting Accelerated Drug Approval

  Examine the various routes for expediting drug development and approval in member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as well as in Australia.

• Considerations For Using RWD/RWE In Oncology Drug Approvals

  Delve into a collection of select case studies where various examples of RWD/RWE applications are analyzed for strengths and weaknesses as perceived by regulatory agencies, illustrating key insights with regard to study design.

• 5 Building Blocks To Achieving Diversity, Equity, And Inclusion

  Gain insight from several tactics that could arguably contribute to enhancing the diversity and inclusivity of studies throughout the entire clinical trial process.

• Risk-Mitigation Recommendations When Using Technology

  Recent FDA and EMA guidance highlight the importance of human involvement when using technology in clinical trials.

• 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.

• Advancing Use Of Patient Evidence In Decision-Making

  Gain insight from five take-home messages highlighting practical approaches to mitigate risks and providing incentives for utilizing patient-generated data.

• 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.

• Optimizing Clinical Trials Through Ethical Research

  Learn about ethical research practices and how the approved uses of AI technology in the life sciences industry must be developed within a regulatory framework to ensure its meaningful and standardized utility.

• Data Analytics Could Enable Trial Diversity & Meet New Regulations

  Explore the ways that data analytics could serve as a reliable mechanism to ensure the representation of diverse participants in their trials and meet new regulations.

• How Generative AI Could Transform Content Development

  Consider the ways in which generative AI can enhance the productivity of skilled professionals like medical writers, bridge skill gaps, facilitate resource upskilling, transform data into actionable intelligence, and provide valuable insights.