PharmaceuticalOutsourcingQ42020 - 30


COVID-19 and Clinical Research:
How New Challenges are
Accelerating Lasting Solutions

Ed Ikeguchi

As with the rest of the world, clinical trial sponsors and those that

lead to lengthy and often frustrating visits, particularly if the patient's

help facilitate trials have experienced unprecedented change over

record of participation in the care plan is incomplete.

the last year as a result of the COVID-19 pandemic. At the beginning
of the pandemic, when social distancing mandates were widespread
and at their most strict, the industry was faced with many questions
around the ability to continue studies or start new studies in an
environment where patients' ability to visit clinical trial sites was
greatly reduced if not wholly eliminated. Restrictions on patients'
ability to visit trial sites and engage in face-to-face meetings with
caregivers forced all of those involved in running trials to seek out
ways to keep patients on track and engaged and be able to continue
to gather useful endpoint data.

Due to COVID-19, face-to-face interactions at healthcare facilities
have been reduced. Study participants dealing with existing
morbidities (and often multiple morbidities) are at a higher risk for
severe complications should they contract the novel coronavirus.
Understandably, these high-risk groups have been encouraged
to stay home as much as possible. In order to keep patients from
discontinuing their trial participation, technology has been employed
to keep them engaged. Remote technologies ranging from telehealth
to applications that run on smartphones or similar devices are helping
study teams communicate with patients, monitor medication and

This has led to an acceleration in the adoption and use of remote

care plan adherence and can provide a continuous stream of useful

patient engagement and monitoring technologies. Out of necessity,

data on drug efficacy and safety.

our industry has implemented these technologies over the past year,
learning many lessons that will help to continue their critical therapy
research throughout the pandemic, but also setting a foundation for
future trials, post-COVID.

These technologies show great promise for improving engagement
and outcomes. For example, a recent study of diabetes patients
showed that more frequent and regular participation via remote
monitoring technology led to improved glycemic control outcomes.1

Lesson Learned #1: Patient Engagement

Additionally, these technologies remain with the patient 24/7. By

Keeping patients engaged and involved in a study is a challenge for

recognition found in some applications, technology can provide

sponsors and sites during ideal study conditions. In the past, much of

study teams with real-time data on things like dosing adherence.

the engagement work has been done through regularly scheduled

This information gives new insight to study teams around what the

in-person clinic visits. During these visits, site teams are tasked with

patient is experiencing in the gaps between clinical visits. This is

gathering as much data pertinent to the study as possible. This can

an important benefit of remote monitoring technology in normal

Pharmaceutical Outsourcing |

monitoring each dosing, and through features like facial and voice


| October/November/December 2020



Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4