he discussion around patient influencers is becoming increasingly prominent within the healthcare ecosystem. Who are they? What role do they play in developing better patient outcomes and healthcare improvements? How do they positively impact health decisions? This article aims to explore these questions and provide key insights into how the biopharmaceutical industry can and should be collaborating with this important stakeholder group to create positive change in healthcare.

ver the past decade, a series of government-lead events set in motion a sea change in how patient-reported outcomes (PRO) in cancer clinical trials are assessed and reported. PRO measures have long provided an opportunity for the patient’s voice to be heard, and when rigorously implemented, PRO assessments can add quantitative symptom and functional data to help characterize risks and benefits of cancer treatments. An important example is the use of PRO to provide a direct report of symptoms and side effects from the person experiencing them.

The US National Cancer Institute (NCI) and the US Food and Drug Administration (FDA) have created publicly available tools to advance the collection, measurement, analysis, and reporting of patient-reported symptomatic adverse events in cancer trials. These initiatives have had ripple effects, expanding the definition of tolerability, developing guidelines to manage symptoms, providing new tools for industry to enhance dose finding in early-phase trials, and providing PRO data to enhance the patient-clinician interaction at the point of care.

In this article, we discuss:

• NCI’s development of the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), the FDA’s work to identify analytic and visualization methods to describe PRO-CTCAE data culminating in Project Patient Voice;
• future uses of PRO-CTCAE and other PRO data to inform early- and late-stage drug development; and
• the history of sustained scientific collaboration necessary to advance the rigorous use of PRO data to help characterize tolerability of cancer drugs.

igital health and patient-centricity are all the rage these days, with these topics appearing as key headlines across the industry. What does it mean, what’s the value, and why are we not there yet?

The global COVID-19 pandemic shone a bright light on the need for healthcare systems and communities to work for the benefit of all.

What steps are being taken by clinical researchers, the industry sponsors of that research, and the Agency regulating that research to ensure more equitable healthcare in the US, from bench to bedside?

n addition to obvious investments to support various sectors suffering as a result of the pandemic, Canada’s 2021 Federal budget continues its support of previous initiatives related to pharmaceutical policy.

With the view towards rebuilding, the budget also touches on investments in innovation and improving domestic capacity that may benefit the pharmaceutical sector in the long run.

he Chinese pharmaceutical industry, through the first five years of China’s National Medical Products Administration (NMPA) regulatory reform which began in 2015, has experienced groundbreaking changes and stepped into a new era full of blooming innovation and intense competition. Today, the regulatory professionals are facing unprecedented opportunities as well as challenges in this diversified environment.

he spread of COVID-19 and the resulting social activity restrictions have severely impacted drug development and threatened the continuity of clinical trials in the US. Japanese pharmaceutical companies that develop drugs in the US were affected by these unprecedented circumstances as severely as US companies.