GUEST COLUMNISTS

  • Can Anti-TNF Treat Post-operative Cognitive Decline? New Clinical Research Investigates

    People who suffer from post-operative cognitive decline can develop difficulty remembering things and performing daily tasks, and may possibly end up in nursing homes. There are no existing therapies. However, 180 Life Sciences believes it has a novel understanding of how to treat it.

  • Harnessing The Human Virome For The Next Generation Of Gene Therapy Vectors

    Advances in metagenomic sequencing have revealed insights into the human virome with boundless value for gene therapy researchers. This includes exploring the diversity of a family of small commensal viruses called anelloviruses that have never been associated with disease. Anelloviruses are a promising new tool in our effort to overcome today’s limitations in genetic medicine.

  • Collaborating With The FDA For Rare Disease Clinical Trial Success: Our Experiences

    If you are familiar with rare diseases, you know there are unique challenges associated with conducting clinical trials to evaluate potential new treatments for small patient populations. When we set out to design our Phase 2b study for a treatment targeting congenital ichthyosis, we knew we would need a plan to tackle these challenges. Here's how we worked with the FDA throughout the process.

  • Realizing the Promise of Data Sharing: A Multi-Stakeholder Collaboration

    Sharing patient data generated from clinical trials has the power to transform the trial process itself, improving the patient experience and delivering life-saving and life-changing therapies faster and at less cost to society. This article shares the goals and efforts of the Clinical Research Data Sharing Alliance. And you can get involved!

  • Clinical Outcome Assessment Testing: Which Rater Training Method Is Most Effective?

    For trials that utilize clinical outcome assessments as their study endpoints, rater training is paramount in ensuring data integrity by improving inter-rater reliability. The consequences of inadequate rater training can result in increased measurement error and data variance, significant increases in study costs, and incorrectly failed trials. Which rater training method is most effective?

  • 6 Key Principles To Guide The Compatible Reuse Of Clinical Data

    As an industry, we have an obligation to maximize the value and utility of clinical data. Great value for both patients and sponsors can be derived from the reuse of existing data sets, which is why clinical data reuse is an area of increasing interest across the pharmaceutical industry. However, data privacy or data protection laws and regulations still apply.

  • Gilead Sciences’ Innovative Approach To An HIV Clinical Trial

    When Gilead launched its Phase 3 study of investigational lenacapavir for PrEP, the team recognized that any clinical pathways intent on introducing new PrEP options must commit to addressing and effectively bridging existing gaps if we strive to drive real change in HIV prevention. This is the story of how Gilead approached trial design in an innovative manner.

  • Best Practices For EDMS Implementation For Virtual & Early-Stage Pharmaceuticals

    Since the beginning of the pandemic, the clinical trials industry has rapidly adopted electronic documentation management systems (EDMS). However, for virtual and early-stage pharmaceuticals, an EDMS can pose several challenges. This article highlights the key factors that you should consider when evaluating the adoption of an EDMS to avoid the most common pitfalls.

CLINICAL TRIAL WHITE PAPERS

  • Building Empathetic Clinical Trial Recruitment Programs

    Effective and efficient clinical trial recruitment remains a fundamental challenge for ultimate study success. Possible solutions with the most potential to finally crack the code on improving study recruitment lie in the simple need to consider and care about the experiences of those involved.

  • Perspectives And Guidance For Effective eCOA In Global DCTs
    12/10/2021

    It is widely accepted that electronic clinical outcome assessments (eCOA) are the preferred means of collecting participant data. Explore how eCOA is a flexible solution that allows for the remote collection of patient, clinician, and observer-reported outcome data.

  • Ethical And Biosafety Oversight Of Gene Transfer Clinical Research: What Sponsors And CROs Need To Know
    9/30/2021

    This paper focuses on important points to consider when planning to initiate clinical trials with these products at sites inside or outside the USA, if the research is subject to rules and regulations of the FDA and/or the National Institutes of Health (NIH) of the United States.

  • Clinical Relevance Of Measuring Respiratory Rate
    7/10/2020

    This paper outlines the importance of measuring respiratory rate and explains how respiratory rate is assessed from photoplethysmography. New technology now enables a wrist-worn wearable device that measures and provides respiratory endpoints including respiratory rate and resting respiratory rate.

  • Virtualizing Clinical Trials
    6/10/2021

    The backbone of drug and medical device development is the clinical trial process. A trend is emerging toward greater patient involvement in clinical trials — making them more patient-centric. Explore examples of real-world experience with clinical data collected by the patients themselves.

  • Clinical Trials Are Better, Faster, Cheaper With Big Data
    7/6/2021

    The path from study design to approval is long, winding, and expensive. This white paper explores how researchers are using artificial intelligence and advanced analytics to speed up the process, reduce costs, and get effective treatments more swiftly to those who need them. And they’re tapping into an underused but rapidly growing resource: data on patients from past trials. Learn how researchers are using analytics and existing patient data to ease recruitment, reduce costs, and accelerate timelines.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Case Study: Accelerated Enrollment
    1/24/2022

    When a customer needed to enroll patients for a colorectal cancer (CRC) screening study, it contacted Elligo for help. Elligo, utilizing its decentralized clinical trial model, identified and enrolled the number of patients needed for this study ahead of schedule, decreasing screening and enrollment timelines.

  • How To Accelerate Your Clinical Trial Through Healthcare
    1/24/2022

    Learn how to accelerate your trial through healthcare with direct access to known patients, their trusted physicians, and extensive site support in this article.

  • Road-Mapping The Journey To Going Public For Life Sciences Companies
    1/14/2022

    Would going public be more manageable and low-risk if the right expertise and systems helped a company move through the process efficiently and established a firm foundation for its future? Learn more in the available article.

  • Company Size And PPAs – Peeling The Layers Of Phase II/III Service Provider Selection
    7/21/2021

    If only there were an easy button for service provider selection. This process continues to evolve and grow in complexity as clinical trials do the same. Layer in factors such as company size and preferred provider agreements (PPAs) and you can find yourself quickly overwhelmed by provider options and service offerings.

  • What Are Decentralized Trials And Why Do They Matter So Much Today?
    5/17/2021

    The aim of decentralized trials is to encourage patient participation by reducing or eliminating the need for travel to sites. These trials are conducted remotely, with subjects needing far less, or no time at the traditional clinic or hospital. This is only possible through the advancement of technology, driving an increasingly mobile user landscape than ever before.

  • AI-Assisted Indexing Improves TMF Management
    5/24/2021

    The timely and accurate filing and indexing of documents for the Trial Master File is one of the most significant compliance challenges facing organizations today. In this case study, learn how Phlexglobal’s advanced machine learning technologies reduced a pharmaceutical company’s document processing time by 16% while maintaining 98% accuracy.

CLINICAL LEADER CONTENT COLLECTIONS

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In this e-book, we take a close look at RWE and RWD. What is it, how is it being used, why all the hype over it, and how the use of it may bring together the worlds of pharma R&D and healthcare. But more importantly, how can we best tap into the data we have available to us today to improve clinical studies and healthcare in the future.

More Content Collections

FOCUS ON PATIENTS

  • When Gilead launched its Phase 3 study of investigational lenacapavir for PrEP, the team recognized that any clinical pathways intent on introducing new PrEP options must commit to addressing and effectively bridging existing gaps if we strive to drive real change in HIV prevention. This is the story of how Gilead approached trial design in an innovative manner.

  • Earlier this year, the MedTech Color Collaborative was created with a goal of convening a diverse cross-section of industry stakeholders to work together to identify issues and opportunities for improvement in this critical space. The group shares and curates existing knowledge and strives to develop evidence-based solutions and best practices to address the health inequities facing minorities. 

  • The Clinical Trials Transformation Initiative (CTTI), co-founded by Duke University and the FDA, consists of a group of individuals and organizations working to improve the quality and efficiency of clinical trials. This article shares CTTI's goals to improve clinical trials and modernize research, as well as how you can get involved.

EMBRACING DIVERSITY & INCLUSION