FEATURED ARTICLES

• Localized Attention On A Global Scale: A Phase III Study In Early Alzheimer’s

  In a recent Phase III study focusing on mild cognitive impairment (MCI) and mild Alzheimer’s disease, Worldwide Clinical Trials worked with 250 sites across 14 countries in North America, Europe, and the Asia-Pacific region.

• Considerations Regarding Noninferiority: A Case Study In Multiple Sclerosis

  To illustrate the seven key elements that should be considered before selecting an NI study design, this paper presents a case study examining the potential use of an NI design in a study involving relapsing remitting multiple sclerosis (RRMS).

• Complexities Of Glioblastoma Multiforme Clinical Trials

  New innovations are creating opportunities for therapeutic research, and Worldwide Clinical Trials is poised to support development in GBM treatments. In this short video, Alaeddin Homsi, MS, BS, Executive Director for Oncology Project Management, discusses Worldwide’s increasing commitment to oncology research and its recent work supporting GBM studies, in particular.

• Wearables And Quality Assurance In A Clinical Trial Setting

  The available white paper discusses how wearables can lead to the creation of vast data sets that may lead to new insights about how a patient feels or functions and about the impact of innovative therapies on healthcare utilization.

• Looking Beyond The Light At The End Of The Tunnel

  In the available white paper, read how numerous publications have examined the impact of the COVID-19 pandemic on both cardiac health care delivery in general and cardiometabolic research in particular.

• COVID-19 Vaccine Development: Building On A Legacy Of Innovation

  The SARS-CoV-2 virus at the center of the COVID-19 pandemic may be novel, but the coordinated research and development efforts to create a vaccine for it are not entirely so. They borrow from experiences derived from more than 50 years of successful vaccine development programs. Read Worldwide’s take on the history of medicine and the development of the coronavirus vaccine.

• Opiod Sparing: Prescribing Less Is Insufficient

  Chronic and acute physical pain often requires treatment with strong analgesics. A treatment with opioid-sparing benefits could help mitigate the risks associated with opioids in one or more ways. This white paper analyzes how opioid-sparing benefits could help mitigate the risks associated with opioids, and argues that the opioid-sparing therapy must not diminish the level of analgesia obtained.

• Feasibility In Uncommon Populations: Balancing And Improving the Interests Of Patients, Sites, And Sponsors

  This paper examines ways in which the approach to feasibility in rare, geographically dispersed populations has evolved, with particular attention to the perspectives of those stakeholders responsible for facilitating trial design and operations. How the research and development process approached that goal previously, modified the process recently, and continues to examine new directions for innovative solutions in the future is a focus of review.

• Your Strategy For Patient-Forward Rare Disease Research

  Collectively, rare diseases make up the most challenging area in clinical research. Individually, they present unique hurdles for pharmaceutical companies and CROs. Our eBook explains how to develop creative strategies to plan and operationalize rare disease programs that put the patient first. And second. And third.

• ALS Studies And Lessons Learned From COVID-19

  For ALS trial sponsors and CROs alike, the need to protect the health of study participants, the study team, on-site health care professionals, and the broader community in which the trial centers are located is of paramount importance. The question is, how to ensure this protection and conduct the trial? The answers lie in preemptive mitigation and adaptive processes that can be implemented flexibly as conditions evolve.

• BioPharma Market Launch In The Age of COVID-19

  The COVID-19 pandemic (C19) has complicated the transformation most life-sciences companies – generally irrespective of size and development status – have been undergoing for the past few years. It has definitely affected the pace and methods used to achieve both clinical and commercial development success. Moreover, it has trained a bright light on the reasons that CEOs have been striving to transform their organizations. This paper will look at lessons learned from a wide range of interactions with pharmaceutical companies during this dynamic period. C19 has altered the landscape of options when it comes to addressing many of these challenges, and this paper will explore how CEOs might respond in their own novel ways.

• External Controls (Part II): Informed Choices Amidst A Portfolio Of Options

  Regulatory concepts referable to the creation of an external control group have long been noted and occasionally implemented, particularly for diseases with severe morbidity, mortality, and unmet medical need. This white paper outlines the potential benefits and disadvantages of using an external control within a program and the key criteria from representative programs that have successfully passed industry and regulatory muster to use external controls in registrational programs.

• Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research

  Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

• Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests

  With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug.  Having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

• Reinventing Neurodegenerative Protocols To Overcome COVID-19 Hurdles

  A global, pivotal Phase III Alzheimer’s trial aiming to screen 6,000+ patients faced unforeseen challenges when the COVID-19 pandemic hit just a few months into recruitment. Finding a solution that provided proactive screening, assessment, and IP administration techniques enabled a new approach to collecting patient data and administering required IP and study visits which preserved the study integrity.

• Developing Gene-Based Therapeutics

  The regulatory, operational, and commercial forces that impact gene therapy development continue to evolve dramatically – not just in the US but throughout the world. This paper explores strategic considerations for regulatory, operational, and commercial success.

• How COVID-19 Is Transforming Perceptions And Approaches To Clinical Research

  The COVID-19 pandemic has forever changed our perceptions of clinical research—but how has it changed them? That was the underlying question in a recent two-part survey of C-Suite executives. By taking a deeper look into what fuels these attitude shifts, we were able to gain a clearer picture of how COVID-19 may transform the industry.

• 5 Ways To Adapt Your Neurodegenerative Disease Trial To The World Of COVID-19

  When COVID-19 exploded around the world, in-progress neurodegenerative disease trials – as well as studies preparing to launch – were faced with a sudden and unexpected challenge: how to adapt their approach with the least disruption possible. This ebook provides practical tips for adjusting study operations to overcome unforeseen disruptions.

• Pharmacy Services In A Phase I Clinical Research Unit

  This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.

• Ensuring Access And Approval For Innovative Therapies In Scleroderma

  Clinical research and development programs for innovative therapies in scleroderma must accommodate the diverse data needs of multiple stakeholders. This white paper explores the requirements to create an integrated program capable of demonstrating the “value” of a new product, as well as clinical utility and therapeutic novelty.