GUEST COLUMNISTS

• 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.

• Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?

  This article will share some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings — the inaugural UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Summit and the Clinical Trials Transformation Initiative (CTTI) Virtual Meetings for Stakeholder Engagement on ICH E6.

CLINICAL TRIAL WHITE PAPERS

• Improving Regulatory And Operational Performance In Orphan Drug Development

  The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

• What Your Clinical Study Design Reveals About Your Clinical Packaging Needs

  Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success. To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design.

• Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments

  Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.

• Actigraphy For Pain And Activity

  Pain is a complex medical condition that involves many physiological functions. Assessment of a patient’s sleep and activity can be critically important for understanding the full dimensions of their pain and the effect of therapies.

• Trial Results Summaries: Improving Patient Communications

  This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.

• Infectious Disease Challenge Studies: Ethical Issues In Causing Disease For Medical Knowledge

  Infectious Disease "challenge" studies are ones in which healthy participants are intentionally infected with pathogens in order to investigate the cause, prevention, and treatment of infectious diseases- but are they ethical? These studies, while useful, pose ethical concerns, and numerous criteria must be met for an infectious challenge to be ethically permissible.