GUEST COLUMNISTS

  • 4 Best Practices That Kept A Biotech’s Clinical Trial Moving In The COVID-19 Era

    The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.

  • Can CROs Rise To The Patient Access & Recruitment Challenge?

    You have a human condition to improve and a protocol to follow. All smooth sailing from here, right? Indeed, even the most well-planned clinical trial is dead in the water if the needed patients are not accessible or willing to participate.

  • How Can We Begin To Solve Unconscious Systemic Bias In Clinical Trials?

    Halting disparities in clinical trials during the time of COVID-19 will take eradicating unconscious bias, building trust in diverse communities, dispelling long-held myths, constructing relationships, and educating patients, family members, and physicians.

  • 5 Bad Habits The Clinical Trial Community Needs To Break ASAP

    The issue of clinical trial costs, both in terms of money and time, is big, complicated, and not at all new. In this article, I will not attempt to address or solve all of the problems that contribute to these high costs, but I will highlight some continuing root causes that I believe persist needlessly.

  • 3 Essential Considerations For Running Global Clinical Trials

    In recent years, global clinical trials have become standard, and for a good reason. Expanding clinical trials across the world gives the investigational drug better opportunity to demonstrate its true impact. In this article, Dr. Roger Tell looks at three key considerations when designing a global clinical trial: selecting the most appropriate trial sites with a representative patient population, choosing to work with the right partners, and ensuring you are up to speed with local regulatory and clinical requirements.

  • Unpacking FDA’s New Guidance On Collecting Patient Experience Data

    The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.

  • Transformative Reflections On The Life Science World, Post-COVID-19

    The post-pandemic response has led to drastic public health changes and new ways of creating diagnostics and treatments. COVID-19 was a turning point. The pandemic exposed weaknesses in internal processes, reliance upon traditional methodologies, and leadership gaps. It demonstrated a valuable capacity to leverage innovative technologies for prioritizing patient safety, to rapidly implement creative ways of enabling healthcare providers to continue providing care, and a new framework for solving complex medical challenges.

  • Searching For Clinical Trials: How Can We Improve The Patient Experience?

    While adherence to ClinicalTrials.gov guidance is not optimal, the bigger issue is the widespread absence of patient focus in most brief titles and brief summaries.

CLINICAL TRIAL WHITE PAPERS

  • Maximizing Success In Early Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents

    Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early phase oncology trials and developing significantly improved therapeutics for patients.

  • Three Considerations For Successful Global Sample Processing With A Central Laboratory

    Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials. This paper reviews three of the keys to success for global sample processing.

  • Informed Consent: 6 Approaches To Increase Clinical Trials Participant Comprehension

    Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ understanding of the studies they are asked to join.

  • ICH GCP E6 (R2): A Primer For Small Biotech And Specialty Pharma Companies

    With recent updates to the ICH Good Clinical Practice guidelines biotech and specialty pharma innovators face even greater sponsor responsibilities, the most significant of which may be design and development of Clinical Quality Management Systems to achieve compliance with the revised guidelines. In this white paper, we will explore the revised guideline and discuss its impact on small biotech and specialty pharma sponsors, with a focus on risk-based approaches to quality management.

  • Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies

    Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies which will almost certainly require cold chain handling.

CLINICAL TRIAL APP NOTES & CASE STUDIES

CLINICAL LEADER CONTENT COLLECTIONS

19_07_CL_RealWorldEvidenceEbook_300x200

 

In this eBook, we take a close look at Real World Evidence. What is it, how is it being used, why all the hype over it, and how the use of RWE is bringing 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. Our experts include executives from Bristol-Myers Squibb, Pfizer, the University of Southern California, and Harvard Medical School.

More Content Collections

FOCUS ON PATIENTS

EMBRACING DIVERSITY & INCLUSION

  • How Can We Begin To Solve Unconscious Systemic Bias In Clinical Trials?

    Halting disparities in clinical trials during the time of COVID-19 will take eradicating unconscious bias, building trust in diverse communities, dispelling long-held myths, constructing relationships, and educating patients, family members, and physicians.

  • 6 Practical Ways To Increase Diversity In Clinical Trials

    Even when a certain disease is more prevalent in a particular minority population, it can still be difficult for trial investigators to reach the right individuals. As an industry — as a group of researchers dedicating our lives to improve the health of others, regardless of their race, age, gender, or disease — how can we do better?

  • Diverse Enrollment In Clinical Trials: What Do Successful Research Sites Have In Common?

    Diverse enrollment in clinical research studies is a complex issue that has multifaceted implications for clinical research sites. An understanding of the research site community’s perceived awareness and current ability to enroll these populations is lacking in the clinical trials landscape.

LIFE SCIENCE INDUSTRY EVENTS