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

• Bayesian Methodologies To Address Clinical Development Challenges For COVID-19 Drugs, Devices And Biologics

  There are numerous challenges when designing COVID-19 trials including include lack of prior data for candidate interventions/vaccines due to the novelty of the disease and the evolving standard of care as knowledge accumulates on the COVID-19 disease, and emerging evidence from completed trials. Bayesian statistical methods are very well suited to address these challenges due to their ability to adapt to knowledge that is gained during a trial.

• SEO, UX Key To Finding – And Understanding – Clinical Trials

  According to experts, sponsors’ clinical trials websites should focus on three primary areas: patient-centric content and design, navigation and mobile friendliness.

• Rapid Change, Real Promise: The Future Of Rare Oncology Research

  Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.

• How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency

  With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.

• Successful BYOD In Any Phase

  The idea of BYOD for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results. Read more about the Advantages and Misconceptions of BYOD and what you should consider if you are deciding whether BYOD is an option for your study.

• 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

  Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.