Introduction

The unprecedented challenges brought about by the novel coronavirus pandemic have brought into focus the use of digital technologies cross the health care spectrum.

For example, experts predict a long-term impact on clinical trials of drugs and medical technology processes from the COVID-19 outbreak. The practical difficulties of collecting information at specific sites during the mobility restriction of the pandemic have acted as a catalyst for mobile collection technologies. The US Food and Drug Administration has made that point in a formal way in its initial guidance for sponsors on how to address issues raised by the outbreak in the context of clinical trials for other products. That guidance noted numerous times that “alternative methods” may need to be considered for monitoring sites, such as “virtual visits.”

The agency is also working on guidance on decentralized trials. Decentralized trials refer to a decentralization of clinical trials operations in which technology – such as telehealth, computers and digital applications – is used to communicate with study subjects and collect data. In fully decentralized trials, everything is done remotely.

The European Medicines Agency has also produced new guidance for pharmaceutical companies wanting advice on the use of digital technology-based tools in drug development and the preparation of marketing authorization applications.

Digital technologies are increasingly being used in clinical trials, for example in monitoring patients’ clinically relevant parameters, digital remote monitoring of drug intake, and electronic patient signatures on informed consent forms. Technologies that might be used include sensors (ingestibles and implantables), mobile health tools such as wearables for remote patient monitoring, video consultations with patients, health data analytics and digital record systems.

Digital tools are also coming to the fore in the diagnosis and treatment of patients. Aside from the widely reported boon to telehealth providers, such as Doximity and Teladoc, the impact has also been seen in medtech firms. In companies like Philips, the pandemic has seen strong growth in “connected care,” embracing informatics, monitoring and analytics, population health management, and therapeutics. These technologies enable workflows and informatics data to support telehealth. This allows companies to connect with patients and health care services in different care settings.

And as pharma and medtech companies are hoping to emerge stronger from the global lockdown by using digital tools to accelerate its business transformation. Companies with representatives worldwide who were usually on the road visiting healthcare professionals, but were confined to home for months, have had to come up with innovative digital tools for physician engagement and setting new key performance indicators for sales forces.

This eBook brings you a selection of key articles from our publications, ranging from a broad overview of the field from In Vivo to commercial strategy and R&D analysis from Medtech Insight and Scrip and policy and regulatory considerations from Pink Sheet.

Phil Greenfield Editor In Chief| Medtech Insight

Informa Pharma Intelligence