Virtual Clinical Trial presentation

1. Virtual Clinical
Trials
Dr. Sahil Kumar

2. OUTLINE
Introduction
What is it?
How it works?
Components, Process overview
Emerging technologies
Benefits of Virtual Clinical Trials
Challenges with Virtual Clinical Trials
Case Studies
Future of Virtual Clinical Trials
Conclusion

3. Subject participation in clinical research most
critical for successful drug development.
Conclusions derived from the clinical trial directly
impacted by the extent of subject participation.
Biggest challenges with conventional trials:
• Patient enrollment & retention
• Protection of patient’s rights
• Compliance
INTRODUCTION

4. Making it all about
the patient

5. Virtual Clinical Trial (VCT) :
• New method of collecting safety and efficacy data
from clinical trial participants, from study start-up
through execution to follow-up.
• Trials take full advantage of technologies (apps,
monitoring devices) and online social engagement
platforms to conduct each stage with the comfort of
the patients.

6. The Components & Process Overview
Open
Enrolment
• Through
online
avenues
• If adequate
access present,
any patient
can
participate.
Limited Sites,
Centralized
management
• Single study
coordinating
center under
the direction of
the PIs.
• PI reviews data
as it is
collected,
monitors.
Data
Collection
• Patients/
Caregivers
• Healthcare
providers
• EHRs
• Laboratories
• Support groups
• Governmental
oraganizations
• Home Health
Agencies

8. Emerging technologies that make a virtual trial
possible:
Challenge Overcoming Technology
Patient Recruitment Social media, mobility
Patient Retention
Social media, mobility, Remote
Patient Monitoring, e-ICD
Patient Compliance
Mobility, Remote Patient Monitoring,
e-PROs, IRT, e-ICD
Patient Engagement Social media, mobility, IRT
Patient driven Data
Collection
Remote Patient Monitoring, e-PROs,
IRT

9. 1.) Social Media
Objective is:
• to build awareness.
• to understand recruitment feasibility.
• to communicate about the successful completion
of previous trials and new product launches.
• to build a rapport with the patients & inspire
trust.
• to help save time - screening eligible patients
using specific questionnaires.

12. Clinical Trials.gov and International Clinical Trials
Registry Platform (ICTRP). These registries serve as
online repositories.

13. International Clinical Trials Registry Platform (ICTRP)

14. 2.) Mobility
Use of next generation communication solutions such
as mobile devices (smart-phones and tablets)
Speedy and cost effective connectivity
Locate nearby trial sites.
For example, GlaxoSmithKline developed an app
for the iPhone.
Likewise, Novartis uses Clinical Trial Seek and
My Net Manage mobile apps.

15. 3.) Remote Patient Monitoring
Direct data capture is a proven cost effective
measure to engage patients and improve retention.
Mobility enabled medical devices alert staff if a
patient needs urgent medical attention.
Alere™ HealthPal,  an electronic health record,
such as Microsoft's HealthVault.
Medication Event Monitoring System™ (MEMS)
Glucometers include features to register the day,
date, and time of data capture  electronically
captured and transferred to a database.

16. 4.) Electronic Patient Reported Outcome
Data Capture Tools
e-PRO instruments such as e-diaries are designed
for patients to record and report well specified and
reliable observations electronically.
Less errors, provides real time access to data,
enable trigger alerts and notifications.
PROMIS (2004)

18. 5.) Interactive Response Technology
IRT provides a centralized application and database
that can provide patients with automated access.
IRT can also be used - to educate and guide patients,
much like virtual nurses, and enhance compliance.

20. 6.) E-Informed Consent
Mytrus, an innovative clinical
technology and services
company, has launched an iPad
application that explains
informed consent prior to
clinical trial subject enrollment.
Mytrus uses animation and
other visual aids to simplify
patient education and informed
consent processes.

21. Benefits of Virtual Trials
Single Facility
More cost-effective
Maximizes enrollment
Less frequent travel, automated data collection,
↑ patient retention

22. Benefits of Virtual Trials
Patients with mobility issues can participate
Elimination of source document
verification
Decisions to terminate a drug’s development
could also be made faster

23. Scenarios Best Suited
Rare Disease or
Exposure
Restricted
Access to Study
Sites
Data from
Multiple Sources

24. Challenges with Virtual Trials
Biggest challenge is developing trust
Great understanding of digital ecosystem
required
Generally effective with young population
Patient concerns over sensitive data on internet

25. Challenges with Virtual Trials
Sponsors must invest in sophisticated
technology
Some areas of clinical research not ready
for remote monitoring
Diseases that require in-hospital monitoring
not appropriate for this approach

26. CASE STUDY: Pfizer’s REMOTE
Research On Electronic Monitoring of Overactive
Bladder Treatment Experience (REMOTE) with
Tolterodine trial conducted in 2011.
Main goal: Validation - to compare it to a
conventional Phase IV clinical study in order to
determine if the virtual trial design would be a
feasible way to conduct future trials.

27. Salient Features of the REMOTE trial
ID verification, screening questionnaires, informed
consent & recruitment all conducted online
Instructional video available
Lab supplies and blinded study medication (or
placebo) delivered to patient homes
Blood and urine tests conducted during a home visit
or at clinic local to patient
Bladder diary maintained by patient using small
mobile device supplied by Pfizer
Periodic self-assessments completed by patient via
online portal
Individual clinical trial results shared with patient
after study completion

28. Pfizer was only able to enroll 18 patients.
Reported problems: Concerns over large amounts of health
information online, lack of “human” support.
Study was revamped using the patient feedback to include
call centre guidance.
Pfizer’s REMOTE (through failure) gave lessons:
• It is possible to design remote patient-centered,
randomized trials acceptable to regulatory agencies &
IRBs.
• Relying solely on technology without human-to-
human interaction can negatively impact participation.
So what happened to REMOTE?

29. CASE STUDY: Sanofi’s Virtual Diabetes Trial
In 2015, Sanofi announced their intention to
conduct a virtual diabetes trial – named VERKKO.
First clinical trial using electronic informed
consent to be approved by EMA.
Instead of testing a drug, as Pfizer’s trial did,
Sanofi’s European study tested a 3G capable
wireless glucose meter in diabetes patients.
Purpose: To assess the efficacy of an online
patient-investigator communication system.

30. 60 patients — all recruited through Facebook.
The results exceeded expectations in many areas:
74 individuals registered interest, 60 enrolled.
The average age of patients was 56 years old.
Patient satisfaction had a score of 4.52 out of 5.
Improvements observed v/s the comparator study:
9% drop-out rate - same as the comparator study.
Compliance improved 18%.
66% less time in study coordination activities.

31. The Future of Virtual Clinical Trials
Potential concerns about the inadvertent disclosure of
patient data are likely to increase with virtual data
collection practices.
Recruitment and retention of patients with low
computer literacy is a major concern that can greatly
impact the trial and data that it generates.
Perhaps virtual studies will augment rather than
replace traditional study practices and workflows.
Virtualizing aspects of the study may be done when the
circumstances call for it.

32. The Future of Virtual Clinical Trials
Can be used in rescue studies, where traditional
models have failed (e.g. for geographically
dispersed groups or rare disease populations).
Virtual studies will lend themselves well to sensors
and diagnostics, which will continue to increase in
importance as the technology evolves.
Generation of ‘big data’.
It is not an easy road, but likely to offer significant
benefits for certain studies & select populations.

33. CONCLUSION
Patient centricity is a priority for all stakeholders.
Virtual trial model is able achieve this.
With the industry’s ongoing emphasis on effectiveness
and timelessness, virtual trials will become an important
part of clinical research.
Potential regulatory, operational, analytical challenges.
Next generation of millennial patients will come to
expect virtualization, and it is therefore vital for us to
move the needle in that direction, even if just in parts.

34. THANK YOU