Reactivating Clinical Trials in a COVID-19 Era...Apr 24, 2020 · Direct to patient supply has become more important for some members. AE data capture generally follows one of two

1© 2020 All rights reserved | For Syneos Health® use only

Reactivating Clinical Trials in a COVID-19 Era 24 APRIL 2020


A G E N D A

01 Background

02 Summary

03 Continuing trials through COVID-19 – our tailored approach

04 Use cases and examples

05 Restart

06 Best practices


B A C K G R O U N D

COVID-19 Case Tracker: Global Cases and Trends Source: Johns Hopkins University, April 23rd

2,658,387Confirmed Cases

185,434Total Deaths

722,373Total Recovered

3,449,252Total Active Cases

185Countries with Cases

23 April, 2020Last Refresh


We can help you understand how best to proceed

A S R E G I O N S O P E N U P,

B A C K G R O U N D


B A C K G R O U N D

Data Changes Daily, Trends Take Days to Establish Source: Johns Hopkins University, April 22nd

Rate of increase for new COVID-19 confirmed cases is now flattening in many countries in APAC and EMEA, however:

• Still increasing in US, Japan and India

• UK and Russia still to reach plateau

• Africa potentially the next hotspot

0

5000

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15000

20000

25000

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35000

21-Jan-20 21-Feb-20 21-Mar-20 21-Apr-20

Cases – 5-day moving average 3-month view

USA UK ItalyFrance Spain GermanyChina India S KoreaJapan Russia Australia

0100020003000400050006000700080009000

21-Jan-20 21-Feb-20 21-Mar-20 21-Apr-2

Cases – 5-day moving average 3-month view (USA removed)

UK Italy FranceSpain Germany ChinaIndia S Korea JapanRussia Australia


Flattening the Curve: Country by Country Major regions in APAC and EMEA pivoting to re-open, US to follow

01.Conversation is shifting

to what’s next

02.Office/site reactivation

preparedness now in play

03.Clinical Site Trackers in place across Syneos Health offices,

data refreshed daily

04.Employee and patient safety

ensured at every step

B A C K G R O U N D


Country Guidance 22 APRIL 2020

G L O B A L V I E W

80%+ of sites are continuing to interact with Syneos Health and progress trials

Ongoing study has held enrollment – to allow studies to continue – but its critical to understand individual needs

Increased focus on plan of action around restart • Contract with vendors you may need to

support sites • Engagement plan for patients – keep existing

patients engaged (thank you notes, etc.)


R E G I O N A L V I E W

USA• Office/Site Reopening plans in place for every SH site• Princeton lab reopened on limited basis 20 April• PPE supplies to be distributed nationwide with priority for CRAs and

other site personnel

CANADA• Borders with US remain closed. Site monitoring allowed in line with

site guidance• Restrictions lifting in a controlled manner• Commercial business reopening on phased basis

LATAM Peru: extends state of emergency through 26AprBrazil: extends travel restrictions until at least 30AprChile: relaxing lockdown now in some districts





GERMANY, AUSTRIAGradual re-opening of offices and sites over next 4-6 weeks with continuous, rigorous testing to occur.

UK• Travel restrictions in place until early May. • Monitoring allowed in line with site guidance.• Expect regional cities to re-open before London.

ITALY, SPAIN, FRANCE Controlled loosening of restrictions, phased reopening of Syneos offices and site visits within countries.

RUSSIA, UKRAINELockdown and site restrictions in place until end of May.

BELGIUM,NETHERLANDS, POLAND, HUNGARYRestrictions lifting effective week 2 of May.




AUSTRALIA• International and interstate travel restrictions in place.

Monitoring allowed in line with site guidance• Syneos Health working with University of Queensland • to develop vaccine, first human testing early July

SINGAPORE• Semi-lockdown until early May, borders closed• Over 200 sites still open and operating• No delays in oncology studies

JAPAN• Second virus wave forces State of Emergency declared

CHINA • All Syneos office open but staff mostly WFH • 50% of investigator sites open, changing weekly• CRAs allowed to travel within cities or to low risk areas with PPE • Tight restrictions in/out of Beijing

KOREA• 80% of Syneos sites operational, expect to reach near 100% by

mid-May• Rigorous testing and social distancing rules in place


Our Strategies Aim to Ensure Trial Continuity, Data Preservation and Patient Safety Leveraging Our Industry Expertise

CONTRIBUTING EXPERTISE TO THELATEST INDUSTRY GUIDANCE

TRUSTED RESOURCES

Our Latest Insights https://www.syneoshealth.com/insights-hub

Contributions to Industry Guidance https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-investigations

https://www.acrohealth.org/wp-content/uploads/2019/10/CRO-Forum-RBQM-Oversight-Paper-FINAL-Oct-2019.pdf

Podcast Network http://www.buzzsprout.com/85116

Nicole StansburyVP, GLOBAL CLINICAL MONITORING

https://www.syneoshealth.com/insights-hub

https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-investigations

https://www.acrohealth.org/wp-content/uploads/2019/10/CRO-Forum-RBQM-Oversight-Paper-FINAL-Oct-2019.pdf

http://www.buzzsprout.com/85116


Continue During COVID-19

Transition to Restart Starting or Reactivating a Study


Leveraging Best Practices and Lessons Learned• Incorporating lessons learned from

APAC where nations emerge from crisis first

• Risk assessment and mitigation plan developed from APAC and EMEA experience

• Site and patient re-engagement best practices

Continue during COVID-19Triage site/study challenges with immediate solutions

M I T I G A T I O N P L A N

E A R L Y R I S K A S S E S S M E N T S –M O D E L F O R O T H E R R E G I O N S / S T U D I E S

P P E , O T H E R M E A S U R E S S E C U R E D E A R L Y


Starting or Reactivating a StudyPrepare for restart following COVID-19,

maintaining best practices

“ R E S T A R T P L A Y B O O K ”

R E S T A R T A S S E S S M E N T

Staged Approach to Allow Disrupted Clinical Trials to Continue and/or Quickly Restart We are deploying resources to address the new paradigm challenges associated with COVID-19

© 2020 All rights reserved | For Syneos Health® use only 15

Syneos Health Clinical Operations Virtual Forum – Impact of COVID-19

Clinical Operations (CO) representatives generally agreed that their response to the pandemic has been similar and has aligned with interpretations of FDA & EMA guidelines.

Risk assessment plans established for patients for each study. Sites encouraged to make the best decisions concerning access and communications.

Telemedicine may be advantageous for sites with this capability. However, careful consideration in advance is needed due to the risk of increased complexity and the lack of maturity in solutions and experience.

Direct to patient supply has become more important for some members.

AE data capture generally follows one of two approaches.

Most companies now turning to focus on the recovery phase planning. Anticipate surge in workload as sites re-engage with patients and travel restrictions continue. Participants strongly felt the need to establish a new normal for site operations, providing for resilience to similar future events. Future to include risk-based monitoring, direct to patient supply and remote working as key elements of clinical research.

Where Does Industry Stand?

Dr. Nicholas Lakin VP, R&D ADVISORYCLINICAL TECHNOLOGY


RISK ASSESSMENT

Understand the problem and implement personalized site management support

Continue Trials During COVID-19Immediate operational activities Syneos Health can deploy at existing study sites

Determine full scope of problem via study and/or site-level surveying/analysis

Site support such as understanding site level continuity and developing a subject

level assessment

Introduce ‘remote toolkit’ including remote monitoring and direct to patient shipment

Leverage existing telehealth for routine visits and avoid disruption

Optimizing patient recruitment, retention and adherence through remote engagement

Flexible staffing such as providing additional study coordinators to help with data entry

MITIGATION PLAN

Triage immediate needs

INTERVENTIONS

Introduce ‘ready to deploy’ solutions to support each site’s specific needs

C O N T I N U E D U R I N G C O V I D - 1 9

Extend Telemedicine to patient engagementUtilize technology where appropriate


Continue Trials During COVID-19An example of how we can help

SYNEOS HEALTH HAS THE FOLLOWING CAPABILITIES TO ENSURE TRIALS CONTINUE

Telemedicine Leveraged capability that site already owned

and avoided any trial disruption

Direct to Patient ShipmentImplemented through global

Syneos Health contract

Performed Restart Assessment

To understand how best to capture and manage data/process

Mitigation PlanIdentified the need for direct to patient shipment

for continue adherence and the ability to use existing telemedicine for routine follow up

Risk AssessmentRisk assessment evaluated site needs and

identified 80% of sites could function but needed specifics support

Remote MonitoringImplemented by Syneos Health

for each site

Based on your needs, Syneos Health can tailor the solution in a compliant, patient-centric way

C O N T I N U E D U R I N G C O V I D - 1 9

© 2020 All rights reserved | For Syneos Health® use only 18

Syneos Health Clinical Operations Virtual Forum – Recovery Planning & Lessons Learned in Patient Re-engagement

APAC Clinical Sites have begun the process to restart trial operations in a controlled manner, starting with China and Korea.

There is no single path to site re-engagement; many have established guiding principles for restart which focus on patient rights, site burden and employee safety.

Emphasis needs to be put on planning of backlog activities recognizing that this will change dynamically as regional restrictions alter.

Business Continuity Planning (BCP) must include input from local leaders, continuous review of updated government and regulatory guidance to allow triage and prioritization of studies during the recovery phase.

Key topics discussed included: • Challenge to broaden remote SDV and tele-visit approaches for sites without this capability

currently including the increase in staff burden and potential implications with respect to local HIPAA implementation.

• Need to work closely with Medical Writing & Biostatistics to adapt study designs, and the opportunity to use other approaches to analyze data management changes.

• Potential need for COVID-19 testing for CRAs and patients, and CT or antibody testing outside of the study protocol, with associated unexpected costs to studies and likely adjustments to sponsor operating model.

Where Does Industry Stand?

Dr. Nicholas Lakin VP, R&D ADVISORYCLINICAL TECHNOLOGY


Starting or Reactivating Clinical Trials in a COVID-19 Era Preparing for when “normal” business resumes

“Restart Playbook” using best practices

Develop a “Restart Playbook”

Prioritization of sites based on patient safety and trial success

Prepare for rolling opening (and roll back)

Site / travel checklist

Create a risk-based monitoring strategy

Build Capacity for Data & Document Management

Data Management & Statistics Task Force

Recovery approach putting patients first

Phased recovery

Decentralized (virtual) trial options for the future

Expanding virtual and decentralized trial options for the future

R E S T A R T

Aa

RWE to optimize adherence and engagement

Incorporate findings from RWE

DATA AND REAL WORLD EVIDENCE

VIRTUAL / DCT AND PATIENT ENGAGEMENT

RESTART BEST PRACTICES

Site and study risk assessment

Understand regulatory landscape

Document and anticipate and risks

Mitigation plan that includes additional site and patient

support

Aa

UNDERSTAND THE LANDSCAPE


SYNEOS HEALTH HAS THE FOLLOWING CAPABILITIES TO ENSURE TRIALS CONTINUE

Telemedicine Leveraged capability that site already owned

and avoided any trial disruption

Direct to Patient ShipmentEvaluate continued use of direct to patient

shipment with global Syneos contract

Protective measures Evaluate need for PPE or other measures

based on local regulations

Re-start checklist CRA to complete COVID-19 On-site visit

approval checklist prior to on-site visit (one form per visit).

Phased approach to re-openEvaluate phased approach to re-open based on

patient need and trial continuity

Approvals and trainingAll supporting approvals (e.g. LM, BCP team, Sponsor, PI, Site authorities etc.) and training

completion to be attached to checklist as supporting documentation.

Based on your needs, Syneos Health can tailor the solution in a compliant, patient centric way

R E S T A R T

Starting or Reactivating Clinical Trials in a COVID-19 Era An example of how we can help


Trial Continuity, Start and Reactivation Best Practices in a COVID-19 Era

1

Trial checklist and mitigation plan to continue existing studiesIf you are evaluating an existing trial or new one, complete a checklist and mitigation plan. If you have a trial or are considering a trial with Syneos Health, we can do it for you.

2

Understanding clear site/patient/study challenges If you have questions on specific challenges, deploy a site/patient/study survey that incorporates aspects to maximize import of restart.

3

Starting or reactivating clinical trials Develop a restart playbook using best practices including our site and patient engagement checklist, remote monitoring and virtual trial capabilities.

4

Mitigation plan based on best practices Leverage best practices, such as using existing telemedicine tools for routine visits and direct to patient shipment of therapies, to mitigate disruption.


Shortening the Distance From Lab to Life®.

CONTACT:Tim [email protected]

mailto:[email protected]

Documents

Reactivating Clinical Trials in a COVID-19 Era...Apr 24, 2020 · Direct to patient supply has become more important for some members. AE data capture generally follows one of two