SURVEY REPORT

Virtual Trials and the COVID-19 Pandemic

The State of Clinical Trials

2

CLINICAL TRIALS: Major Concerns of the Pandemic

02

VIRTUAL TRIALS: The State of the Industry

03

DATA FIDELITY: Collecting Endpoints

04

SUMMARY: Lessons Learned& Conclusion

05

CHAPTERS

INTRODUCTION

01

Virtual Trials and the COVID-19 PandemicThe State of Clinical Trials

INTRODUCTION

3

The evolution from traditional to virtual clinical trials

was already in process for some contract research and

sponsor organizations prior to the onset of the

COVID-19 pandemic. While new technology is

typically adopted by the life sciences industry at a

relatively slow pace due to regulatory and other

industry-specific challenges, in this case, the cadence

has been accelerated in order to continue, and even

improve, clinical trial operations both during and after

the pandemic.

Virtual trials (also referred to as decentralized,

remote or digital trials) have some generally accepted

benefits as compared to the traditional, physically

site-based trials.

They include:

• Improved patient experience

(less travel/physical interaction)

• Increased cost effectiveness for sponsors/contract

research organizations (CROs)

• Easier patient recruitment

• Greater patient retention/lower drop-out rates

• Shorter timeframes

• More accurate endpoint data

01

INTRODUCTION

4

There is a virtual trial spectrum that ranges from

“full,” where the study is completely virtual and there

is no physical contact between patients and staff, to

“hybrid,” where the study includes some

virtual elements and some face-to-face

interaction. Full virtual trials are feasible in many

scenarios and may be particularly useful in cases

where patients are homebound or spread across a

large geographical area as with rare disease studies.

Hybrid virtual trials are necessary when the clinical

staff must physically treat or examine the patients, as

is often the case with oncology trials.

In April and May 2020, during the COVID-19

lockdown, ERT surveyed 114 clinical professionals on

their organizations’ use or planned use of virtual

clinical trials technology.

ERT Virtual Trials

This report details the findings and suggests that many of the primary concerns indicated by the

respondents, most of which are centered around the patient experience, can in fact, be

addressed by the implementation of virtual trials.

01

CLINICAL TRIALSMajor Concerns of the Pandemic

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01 02 03 05CHAPTERS 04

CLINICAL TRIALSMajor Concerns of the Pandemic

Survey participants were asked to rank

their level of concern in answer to this

question: What are the big issues keeping

you up at night related to running clinical

trials during the COVID-19 pandemic? Had the respondents’ organizations implemented virtual trials prior to the pandemic, they may have been able to conduct screenings virtually and continue with planned studies. That said, there is virtual trial technology on the market today that can be rapidly implemented so that processes can start or resume quickly.

79%Reported that they are very or extremely concerned about screening for new clinical trial patients

Six out of 10 reported that they are “Very or Extremely

Concerned” about:

• Site engagements and study focus (61%)

• Patient compliance (56%)

• Completing data capture for existing clinical trial

patients (56%)

Four out of ten are “Very or Extremely Concerned”

about:

• Drug delivery (40%)

• Preparing/training investigative sites on new

procedures (40%)

This comes as no surprise as during the pandemic

lockdown potential patients were quarantined in

compliance with the stay-at-home mandates of various

government entities.

02

The greatest cause of concern, by a fairly large

margin, is Screening for new clinical trials patients,

with eight out of ten (79%) reporting that they are

“Very or Extremely Concerned” about this issue.

6

CLINICAL TRIALSMajor Concerns of the Pandemic

What are the big issues keeping you up at

night related to running clinical trials

during the COVID-19 pandemic?

What are the big issues keeping you up at night related to running clinical trials during the COVID-19 pandemic? (Total of “Very and Extremely Concerned”)

Screening for new clinical trial patients

Site engagement/study focus

Completing data capture for existing clinicaltrial patients

Patient compliance

Drug delivery

Preparing/training investigative siteson new procedures

79%

61%

56%

56%

40%

40%

02

To varying degrees, each of these “big issues” was a major concern prior to the outbreak of COVID-19. However, requirements around the response to the pandemic escalated their significance as well as the need for sponsors/CROs to quickly address them with enduring solutions.

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CLINICAL TRIALSMajor Concerns of the Pandemic

What is the biggest issue impacting your trials over the next six to twelve months?

Trial management(start-up, too many trials, monitoring, etc.)

Patient recruitment and enrollment

Patient compliance and retention

Analysis/data issues

Staff issues (enrollment, overburdened, etc.)

COVID-19 restrictions

32%

25%

18%

12%

10%

4%

02

Virtual trials can help us reach the other 90% - not just during the pandemic, but also after. With technology we can engage patients from a broader geographical span , manage trials with greater ease and accuracy, and better rely on data from digital rather than manual sources.

Less than 2% of patients worldwide participate in research, and we are using this research to determine the drug effects on the remaining 98%. 90% of those who do not participate in research are willing to take part.*

*Digital Health Patient eBook 8

CLINICAL TRIALSMajor Concerns of the Pandemic

In an open-ended question, survey

participants were asked: What is the

biggest issue impacting your trials over the

next six to twelve months?

Of the (43%), two out of ten reported issues with:

• Patient recruitment and enrollment (25%)

• Patient compliance and retention (18%)

43 %Indicated patient issues as the biggest ones affecting their trials

02

Patient-related challenges can be addressed through the implementation of virtual trials. Recruitment and enrollment can be managed digitally, not requiring an in-person interaction. Compliance may be increased because of the reminders provided to study participants through apps, devices, etc., and retention may be higher because of the ease of an in-home, digital experience versus having to regularly travel to sites and manually document experiences.

9

CLINICAL TRIALSMajor Concerns of the Pandemic

32%Almost one-third reported that trial management (start-up, too many trials, monitoring, etc.) was the biggest issue affecting their trials.

02

Patient-Centric Trial Management: Here’s how virtual trials can help

• Eliminating the need to recruit patients within a certain radius of a physical site

• Keeping patients engaged and in the study through the last visit• Enabling patients to use technology to communicate their own safety

and efficacy assessments • Collecting site-based ePRO/eCOA assessments remotely• Connecting with patients via virtual visits• Conducting patient home monitoring and assessments• Collecting safety and efficacy data at home virtually or through visit by

site personnel or clinician• Collecting image scans from local providers not involved in the study

In an open-ended question, survey participants were asked: What is the biggest issue impacting your trials over the next six to twelve months?

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VIRTUAL TRIALSThe State of the Industry

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01 02 03 05CHAPTERS 04

VIRTUAL TRIALSThe State of the Industry

When asked, How critical does your organization

view the virtualization of clinical trials?, nearly three

quarters (73%) of survey participants responded

Very or Extremely Critical.

Extremely

Very

Somewhat

Not at all

Don’t know

How critical does your organization view the virtualization of clinical trials?

43%

30%

21%

4%

2%

03

The survey results demonstrate that sponsors/CROs are well aware of the many benefits of virtual trials. They may be motivated to evolve to the new paradigm because of any/all of these reasons: Enhanced data fidelity, increased cost efficiencies, shorter timeframes, easier patient recruitment, greater patient retention/lower drop-out rates due to a more convenient and satisfying patient experience.

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VIRTUAL TRIALSThe State of the Industry

Then when asked, Were you conducting virtual

trials prior to the COVID-19 pandemic?, one third

(33%) of survey respondents said yes,

demonstrating that the various technologies

involved were well on their way to being adopted

by the industry before current conditions.

Were you conducting virtual trials prior to the COVID-19 pandemic?

3%Don’t know

64%No

33%Yes

03

A silver lining of the pandemic may be the acceleration of the adoption of virtual clinical trial technologies to the benefit all stakeholders in the ecosystem.

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VIRTUAL TRIALSThe State of the Industry

Next, survey participants were asked: What changes are you making to

existing trial models to address the challenges of the COVID-19

pandemic?

What changes are you making to existing trial models to address the challenges of the COVID-19 pandemic?

6%

Incorporating some virtual trial elements

11%

7%

75%

No changes

Going completely virtual Other: Please specify

03

The response to this question demonstrates the swift action taken by study sponsors and CROs to continue existing trials and begin planned trials despite the constraints of the pandemic. While the COVID-19 ecosystem may have been the forcing function to “go virtual,” the technologies implemented may have already been on the organizations’ longer term IT plans and should serve them well in the future.

Eight out of 10 respondents (82%) reported that their organizations are adopting virtual

trial technologies

• Three-quarters (75%) said they are incorporating some virtual trial elements

• Seven percent (7%) said they are going completely virtual

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VIRTUAL TRIALSThe State of the Industry

When asked, At what stage is your company in implementing

virtual trials?, 9 out of 10 (90%) participants demonstrated that

their organizations are somewhere along the continuum of virtual

trials implementation.

At what stage is your company in implementing virtual trials?

We are implementing someaspects of virtual trials

We are formulating our strategy now

We’ve developed strategies but havenot yet implemented virtual trials

We are fully implementing virtual trials

We haven’t identified the need

Don’t Know

46%

23%

11%

9%

1%

11%

03

The survey results indicate agreement that the time is now for the paradigm shift from site-based clinical trials to full or hybrid virtual clinical trials. Some organizations have already started or completed the evolution, while others are in the planning stages.

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16

Are you currently cancelling studies due to concerns about patient access to investigate sites? If so, what percentage of your trials?

VIRTUAL TRIALSThe State of the Industry

100% 76% - 99% 51% - 75% 25% - 50% 1% - 24% 0%Not cancelling

Don’tknow

3% 4% 5%

24%

51%

2%

13%

03

When asked about study cancelations due to

patient access concerns because of COVID-19,

more than half (51%) of the respondents said

they are not cancelling any studies, greater

than one third (35%) said they are.

Since stay-at-home orders were in place in most

locations, it can be deduced that some portion of

the 51% have virtual trial elements incorporated

into their studies.

CAPTURING ENDPOING DATA

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Companies cancelling clinical trials due to COVID-

related patient access challenges are turning to a mix of

channels to keep patients engaged.

If you are cancelling or considering cancelling studies due to concerns about patient access, how will you keep patients engaged during the hiatus?

VIRTUAL TRIALSThe State of the Industry

3%

Digital channel strategies

27%

11%

39%

Investigative site contact

Social media Other

03

There is a tight link between patient engagement and patient retention. Study participants are less likely to drop out when they are fully informed. It’s critical for sponsors/CROs to stay in active, two-way contact before, during and after the trial –especially during a hiatus.

DATA FIDELITYCollecting Endpoints

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01 02 03 05CHAPTERS 04

DATA FIDELITYCollecting Endpoints

Respondents are fairly evenly divided on the percentage of

their studies’ endpoints that could be collected virtually.

What percentage of your studies’ endpoints could be collected virtually?

100% 76% - 99% 51% - 75% 25% - 50% 1% - 24% 0% Don’tknow

2%

14%11%

23%

4%

31%

15%

04

This information suggests that at this point in time, only 2% of studies could be full virtual trials, and 80% hybrid. As existing data collection technologies increase in adoption, and new ones are developed, these percentages will shift.

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If you are involved/going to be involved in a virtual clinical trial, how are/will you collect the data?

Patients using devices to enter data directly intostudy portal (web, phone, handhelds, etc.)

Patients using telehealth system to ‘meet’with site personnel via video chat

Capturing data directly from sensors, like activitytrackers, sleep monitors, etc.

Investigative site personnel goingto patients’ homes

We will not be involved in virtual clinical trials

Other

75%

75%

49%

7%

7%

32%

DATA FIDELITYCollecting Endpoints

04

Because data is coming from several different sources, it is imperative that the sponsor organization or CRO has systems in place that can accurately integrate and process the data, yielding reliable analytics for the patient, regulatory bodies and the organization itself.

Virtual trials address the data visualization challenges of:• Integrating geographic COVID infection rate data to mitigate risk

• Managing compliance risk due to little/no in-person patient interaction with sites

• Collating and analyzing the study, site and patient data through eCOA

• Integrating with ECG, spirometry and imaging equipment

• Connecting imaging readers/radiologists to the tools they need despite travel

restrictions

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SUMMARY: Lessons Learned & Conclusion

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01 02 03 05CHAPTERS 04

SUMMARYLessons Learned & Conclusion

What are the most important lessons that your organization is learning as a result of COVID-19?

25%

18%

11%

10%

8%

11%

4%

2%

Implement virtual technologies

Be open-minded/flexible

Be efficient

Be innovative

Communicate

Be prepared/have a back-up plan

Be safe

Leverage existing relationships

05

Innovation in trials can take time. COVID-19 is pushing

team members to be open-minded and creative.

COVID-19 is bringing innovative approaches - such as

decentralized trials – forward.

(Write-in response to the question, What are the most important lessons that your organization is learning as a result of COVID-19?)

“”

We have all learned many new lessons from living and working through a pandemic. For the betterment of human health. Let’s hope the mode of accelerated innovation is one that stays with us long after the pandemic has passed.

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SUMMARYLessons Learned & Conclusion

05

Effective virtual trial enablement requires collaboration and planning between all trial stakeholders. To achieve this, it’s important to work

with a trusted partner that can help you:

03. Operate at Global ScaleCollecting and delivering data from patients around

the world presents many challenges. The right

partner can help with protocol design, patient

education/training , device logistics and data

analytics.

02. Visualize Data and ResultsTools that visualize performance indicators like

study progress, and compliance and analyze safety

and efficacy data from multiple sources are also key

to proactive study-management decisions that

protect study outcomes.

01. Engage and Retain PatientsKeeping patients engaged through their last visit is

challenging for any trial at the best of times, never

mind during a pandemic. Home monitoring,

remote interviews and home visits that engage

patients at a distance are critical to keeping them

active and ensuring the flow of high-quality data.

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SUMMARYLessons Learned & Conclusion | Patient Health Journey

05

Clinical Trials

Ensure safety for all involved

Ensure lowest burden to patient & site

Maintain high data fidelity & data flow

§ Try to avoid increased variability§ Document novel approaches/procedures/activities in endpoints captured

Repurpose technology investments where possible

§ Manage new privacy and security issues

Execute pilot solutions in close partnership with vendors

Observe & Ideate Design, Protype & Test Execute & Refine Measure & Optimize

Key actions to support the patient health journey.

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Sponsor organizations and CROs have many

reasons to implement virtual clinical trial

technologies. No matter the impetus,

however, the focal point must be the patient

experience. While some patients may be

resistant to digital elements, particularly the

elderly, in another study conducted by ERT in

2020, a large majority indicated a favorable

attitude towards virtual trials. 96% said they

would be willing to use a fitness watch and

share data for research purposes, while 88%

stated they would be willing to use a

smartphone during clinical research. 93%

said they would be motivated to participate if

they electronically

their rapid adoption because of COVID-19 will

certainly expedite the industry’s reinvention of

a critical process that delivers valuable

therapies and insights to humanity. The post

pandemic new normal is virtual trials. Where is

your organization on its journey there?

SUMMARYLessons Learned & Conclusion

05

“…the focal point must be the patient experience.”

received reports on their data, and 59%

claimed they would be happy to have a

virtual visit with their doctor instead of a

clinic visit, citing convenience as a primary

reason. The adage goes that “necessity is the

mother of invention.” While virtual trials are

not a new invention,

25

7%18%

19%

25%

31%

1%47%

5%12%

34%

How would you describe your organization?

What is your job function?What is the size of your total organization?

CRO

Site

Pharma

N/A

Biotech Medical/Regulatory Affairs Team

Various

Clinical Study Team Centralized Monitoring

Data/ Biostatistician Team

52%

4%11%

33%

< 500employees

500 - 1000employees

1000 - 5000employees

Over 5000employees

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DEMOGRAPHICS

WE ARE ERT

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. In 2019, 75% of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs, and CROs have relied on ERT solutions across 15,000 studies, spanning more than 5 million patients to date.

For more information, go to ert.com or follow us on LinkedIn and Twitter

The study was conducted via the Internet. Selected respondents completed a questionnaire online and submitted their responses to ERT. A total of 114 completed questionnaires was received. Margin of error for a sample of this size is 8.978.

Responses were analyzed by GreyHome Marketing and Research Consulting. Percentages were tested for significance at the 95% confidence level using Decision Analyst's STATS tool, Version 2.0. Additional data analysis was done using SOFA Stats 1.4.6 from Paton-Simpson & Associates Ltd.

Jim Mahon - VP, Chief Strategy & Marketing Officer, ERTA business strategist, Jim brings nearly 30 years of healthcare experience to the discussion of virtual clinical trials. Currently driving business strategy at ERT, Jim has held several senior executive roles at technology and consulting firms where he has articulated growth strategies and managed key strategic programs while providing leadership for product development and management activities.

AUTHORS

Drew Bustos - VP, Global Marketing Strategy, ERTAn expert on design thinking, innovation and technology, Drew currently leads Global Marketing Strategy for ERT, helping to drive the adoption of innovative technologies within the life sciences industry. Throughout his year career, he has led strategy, product management and marketing successfully executing on aggressive growth plans.

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SURVEY METHODOLOGY

MOVING YOU FORWARD

What the industry needs now are reliable solutions that enable the capture of important safety and efficacy data to keep current trials on track, regardless of whether trial patients have physical access to investigative sites and personnel.

ERT’s vast heritage of collecting endpoints outside of the clinic (eCOA and Digital Patient), its infrastructure, and flexible approach to new product development is enabling the acceleration and investment in a broad range of virtual trial capabilities. These broadened enhancements are meeting industry needs and helping customers to continue and start new clinical trials, during and after the pandemic. ERT will continue to emphasize optionality across technological innovations so that customers are best positioned to successfully execute their trials across any protocol complexity or virtual/ physical continuum.

Interested in finding out more? Contact us at:

info@ert.com

www.ert.com