Clinical Guest Contributors

1. 4 Best Practices That Kept A Biotech’s Clinical Trial Moving In The COVID-19 Era 8/12/2020

   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.

2. Can CROs Rise To The Patient Access & Recruitment Challenge? 8/4/2020

   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.

3. How Can We Begin To Solve Unconscious Systemic Bias In Clinical Trials? 8/4/2020

   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.

4. 5 Bad Habits The Clinical Trial Community Needs To Break ASAP 7/30/2020

   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.

5. 3 Essential Considerations For Running Global Clinical Trials 7/28/2020

   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.

6. Unpacking FDA’s New Guidance On Collecting Patient Experience Data 7/28/2020

   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.

7. Transformative Reflections On The Life Science World, Post-COVID-19 7/23/2020

   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.

8. Searching For Clinical Trials: How Can We Improve The Patient Experience? 7/21/2020

   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.

9. Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)? 7/14/2020

   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.

10. How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19 7/7/2020

    For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.