Perspectives on clinical research infrastructure, operations, and innovation.
Key Takeaways FDORA's DAP mandate is law — the statutory requirement survived the January 2025 guidance removal and February court-ordered restoration. Sponsors must comply regardless of guidance...
Most organizations are still managed as if they were machines. Strategy sets direction. Structure assigns responsibility. Processes are meant to create consistency. When results fall short, leaders...
The regulatory landscape for health data has changed more in the past 18 months than in the prior decade—and these changes directly affect how clinical research organizations collect, process, and...
Clinical research is full of dashboards, but very few help us answer the question that matters most for enrollment: Where are we actually losing patients, and why? Most organizations still rely on...
Enrollment challenges remain the single greatest source of delay and cost escalation in clinical research. This article outlines a practical framework for building a Clinical Access Ecos...
This article was originally published on aimronline.org.
This article was originally published on aimronline.org.
This article was originally published on aimronline.org.
This article was originally published on aimronline.org.
Supporting sustained patient behavior change remains one of the most persistent challenges in healthcare. Ulyssean contracts—self-imposed behavior pacts—offer a structured yet patient-centered...
As we reflect on our journey—from defining patient centricity to envisioning a collaborative future and mapping out concrete reforms—it is clear that we stand at the threshold of a paradigm shift....
1. Understanding the Leadership Landscape RFK Jr.’s Vision and Institutional Authority RFK Jr. has long advocated for a radical transformation of the U.S. health system. His proposals include:...
Vision alone is not enough; transformative change requires bold, actionable steps. In this article, we outline a detailed roadmap for evolving our industry toward a truly patient-centric model. This...
Imagine an industry where every facet of drug development is seamlessly aligned with the patient’s journey—a system where all stakeholders work in unison, guided by advanced technology and...
It has become increasingly clear that patient centricity is not just a buzzword, it is a strategic imperative that must guide every decision in drug development. Our industry comprises many...
Understanding Therapeutic Cancer Vaccines Therapeutic cancer vaccines are designed to treat existing cancers rather than prevent disease. They work by introducing specific antigens—most notably,...
Introduction Online community-driven recruitment is increasingly important in clinical research as traditional methods struggle to reach and engage eligible patients. Over 55% of trials worldwide...
Real-world evidence (RWE) is rapidly reshaping clinical research by generating insights from real-world data (RWD), which is information collected during routine healthcare delivery rather than under...
Early Clinical Trials & Inquiry (Pre-20th Century) Early medical experimentation was rudimentary and often driven by anecdote or theory rather than rigorous method. Over centuries, physicians...
AI Architectures in Healthcare and Drug Development: Present and Future Artificial Intelligence (AI) has accelerated innovations in healthcare and drug development, reshaping how we diagnose...
Artificial intelligence (AI) has already demonstrated its utility in healthcare, from interpreting medical images to supporting clinical decision-making and streamlining patient data management. Yet,...
Clinical trials are the engine of medical progress, but the road to innovation often comes with challenges. Drawing from ClinicalTrials.gov data via the CTTI AACT database, I analyzed 3,090...
Clinical trials have long relied on traditional control arms—groups of participants receiving a placebo or standard-of-care treatment—to prove the safety and efficacy of investigational therapies....
Psychedelic substances—such as psilocybin, LSD, and those derived from plants like ayahuasca—have captured significant scientific interest as potent catalysts for profound changes in perception,...
The public conversation about clinical trials often fails to convey the nuanced differences among their various stages. Early-phase studies, focused on safety and tolerability, serve fundamentally...
Artificial intelligence (AI) is increasingly playing a central role in the process of discovering and developing new medicines. Traditionally, the pathway from identifying a promising biological...
Have you ever noticed how our relationship with time shapes not just our productivity, but our very experience of existence? As I navigate the intersection of business growth and clinical research,...
With President Trump’s recent election victory and Robert F. Kennedy Jr. expected to take on a significant role in the administration, the U.S. healthcare landscape is poised for notable shifts....
Introduction As the field of healthcare advances, the integration of complete genomic and proteomic testing into routine medical practice offers a transformative opportunity for personalized care....
In today’s healthcare landscape, patient engagement is crucial for ensuring better outcomes and improved efficiency, particularly in specialty care settings where conditions are complex and often...
/ Enhanced by AI / The success of clinical trials hinges not just on patient access, but also on the depth of information healthcare institutions can provide about their patients. This detailed...
In the intricate world of healthcare and clinical research, the symbiotic relationship between patient readiness for clinical trials and the accessibility of suitable studies is indispensable. This...
/ Powered by A.I. / Providing Value to Patients Before Introducing New Clinical Opportunities In the ever-evolving landscape of healthcare, the introduction of new clinical opportunities offers the...
Here are ten of the most successful clinical research efforts of all time, reflecting their profound impacts on medical science, public health, and treatment methodologies: 1. The Framingham Heart...
/ Enhanced by AI / The involvement of private equity (PE) investment in the Site Management Organization (SMO) sector has sparked extensive discussion within the clinical research community. While PE...
In the rapidly evolving landscape of clinical research, the traditional recruitment strategies, particularly the reliance on call centers, are facing a significant decline in effectiveness. This...
When storing patient information for clinical trials, it's crucial to comply with a range of regulations designed to safeguard patient data and privacy. These regulations not only dictate how...
As the medical community continues to advance in its fight against cancer, two distinct approaches have emerged as front-runners in the realm of early detection: Magnetic Resonance Imaging (MRI)...
In the intricate and demanding field of drug development, Artificial Intelligence (AI) is poised to usher in a new era, dramatically enhancing the discovery process and offering capabilities far...
/ Powered by A.I. / In the clinical research field, the necessity for Principal Investigators (PIs) to personally complete protocol-specific training is critical for upholding study integrity and...
The successful execution of clinical trials is essential for advancing medical research and developing new treatments. However, recruiting suitable participants remains a significant challenge....
Patients who value access to the latest treatment options may still be hesitant to participate in clinical trials due to a range of concerns and misconceptions. Understanding these concerns is...
The clinical trial industry must undergo significant adaptation and innovation to effectively accommodate and foster the development of cell and gene therapies. These therapies represent a new...
Cell and gene therapy are innovative medical treatments that target diseases at the most fundamental level: the cells and genetic material within the human body. Cell Therapy involves the...
The landscape of clinical research is undergoing a transformative shift with the introduction of digital twins, a concept that heralds a new era of precision in clinical trials. Digital twins—highly...
In the digital age, the clinical research sector is increasingly recognizing the transformative power of video content in patient recruitment strategies. The advent of OpenAI's Sora marks a pivotal...
COVID-19 has changed the way people everywhere do things. It has transformed entire industries, seemingly overnight. It has even radically changed the very sites that are studying potential vaccines...
When I think of vaccination administration, I think about a time when five nurses had to hold a young boy down to administer a routine shot. This happened in the clinic where my father worked as a...
Finding and recruiting clinical trial participants who fit the ever-narrower patient profiles sought nowadays to test novel therapies is a serious challenge for the pharma industry. For some clinical...
Today, Wednesday, May 20th, we celebrate Clinical Trials Day. It’s the day our industry takes an opportunity to recognize those who work in the clinical trials industry to improve not only the health...
It is fantastic to see clinical research for COVID-19 getting the attention and encouragement it deserves from the federal government in the form of CMS MIPS credits. For clinicians utilizing...
When the Department of Homeland Security released the Memorandum on Identification of Essential Critical Infrastructure Workers During COVID-19 Response , they highlighted the significance of the...
Patients participate in clinical trials for a variety of reasons, giving weight to considerations such as gaining possible access to treatment options, receiving visit stipends, and making a...