he title of this piece might well refer respectively to 2020 and 2021 (if that had been my intent, I might have titled it Good Riddance and Finally! But it was not).

Rather, as 2020 has come to a close and 2021 has arrived, let’s avoid the much-overused terms used to describe the year just past, and simply thank each of our Editors and numerous Authors for helping make our monthly online publication successful and read regularly all around the world. Indeed, our readership outside US and Canada is routinely half (forty to fifty percent) of the total. We are indeed global, thanks to all of our Editors/Authors and to all of our readers.

We realize that regular contributions to Global Forum require our Editors’ and Authors’ time and effort. We also realize that they have regular jobs, and that this volunteer activity is an additional demand on their busy schedules. For these reasons, we (and our loyal readers) are deeply grateful to them.

s the world deals with the devastating impacts of COVID-19, another public health threat grows increasingly urgent: antibiotic-resistant bacteria. The US Centers for Disease Control and Prevention estimates at least 2.8 million antibiotic-resistant infections occur in the US annually, and more than 35,000 people die. At the same time, investments in new antibiotics to meet the threat are faltering, potentially reducing patient access to life-saving treatments. Fortunately, policy solutions are beginning to emerge.

he European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency.

• submit, evaluate (via scientific and ethical review), and authorize clinical trial applications (CTAs);
• submit any trial-related notifications, reports, and results, up to the clinical study report; and
• serve as the single communication channel between the sponsor and the Member States Concerned (MSC) in the clinical trial.

Flexibility Inherent in a Decentralized Trial Model Will Drive Widespread Adoption

The promised decentralized trial revolution has gained traction in 2020, but we have significant progress to make. Industry wide, the decentralized approach to clinical trials is philosophically embraced for all its advantages but operationalizing the model–particularly mid-flight on studies–requires a commitment to overcoming fear of change. The model’s inherent flexibility will be instrumental to calming any concerns and will drive widespread adoption through 2021.

How a Pandemic-Inspired Model for Clinical Trials Will Impact Research in 2021

Ready or not, the COVID-19 pandemic ushered in a new era of clinical research, the biggest advantages of which are just beginning to surface. In 2021, the life sciences industry will see more remote trial designs adopted by a larger and broader group of sponsors, sites, and patients. As a result, patient access and participation will rise to rates never seen before, more real-world evidence will be captured to enable better outcomes for more indications, and dramatic trial efficiency gains will enable more life-saving therapies to reach more people faster and for less.

onversations about the use of “big data” in clinical research and care have also triggered discussions about the relationship between real-world data (RWD), real-world evidence (RWE), and randomized clinical trials (RCTs). The session Real-World Data (RWD) Management and Application in Clinical Research continued these discussions at DIA China 2020.

ancer has been sometimes viewed as more of an ecosystem (in which patients, healthcare professionals, researchers, industry, regulatory authorities, and payers transfer demands and values to and from each other) than a malignant disease. Due to the vast and increasing disease burden attributable to cancer in China, prevention and treatment of cancer has been listed as one of the fifteen goals in the Health China Action Plan released by the Chinese State Council in July 2019.

igital Therapeutics or DTx, defined as “software as medical device” by the FDA and International Medical Device Regulators Forum (IMDRF), continue to gain traction. According to the Digital Therapeutics Alliance, a non-profit trade association based in the US, Digital therapeutics (DTx) delivers evidence-based therapeutic interventions to patients, driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions.

he report of PANDRH’s Certificate of Pharmaceutical Product (CPP) Project represents the most far-reaching study carried out in the area, a step forward in closing the gaps, and a new opportunity to discuss the healthcare value of CPP in regulatory processes in the Americas.