Decentralized monitoring in clinical trials refers to a modern approach to monitoring the progress, safety, and data integrity of clinical trials using remote and technology-driven methods. Traditional clinical trial monitoring involves frequent on-site visits by monitors to ensure that the trial is conducted according to the protocol and regulatory requirements. However, this approach can be resource-intensive, time-consuming, and may not always provide real-time insights. Decentralized monitoring leverages technology, data analytics, and remote communication tools to monitor various aspects of clinical trials. Here are some key components of decentralized monitoring:

1. Welcome
DECENTRALIZED MONITORING IN CLINICAL TRAILS
S Lakshmi Sai Lahari
B Pharmacy
154/082023
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
1

2. Index
• Introduction
• What are Decentralized Clinical Trails?
• Types
• Requirements for DCTs
• Process
• Benefits of DCTs
• Challenges
• Case Studies
• Future of DCTs
• Conclusion
• References
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
2

3. INTRODUCTION:
Clinical trials (CTs) are essential for determining the efficacy and safety of therapeutic interventions. Current processes for participant
identification, recruitment, and follow-up are expensive and often burdensome for some participants, which may lead to low
participation and retention. This can be anticipated through decentralized clinical trials.
 Decentralized clinical trials (DCTs) are a relatively new concept in the world of clinical research, but they are quickly becoming
more popular.
 In 2023, DCTs are expected to become even more widely used as the technology and infrastructure needed to support them
continue to develop.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
3
The implementation of digital technologies and other novel approaches may help to improve overall CT conduct and could
enable a new operational approach known as "decentralized clinical trials" (DCTs).

4. What are decentralized clinical trails?
DCTs are trials where patients or subjects are treated remotely and data is captured using technologically advanced types of equipment.
They are executed through telemedicine and mobile or local healthcare providers, using technologies, and protocols that are designed in
such a way that all trial activities can be performed at the patient's home or at a remote location.
 Telehealth: Virtual consultations with health care professionals allow long-distance patient and clinician contact, care, advice,
reminders, education, intervention, monitoring, and remote admissions.
 eConsent: Electronic Informed Consent Remote consent or assent signed by trial participants
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
4

5. Types of DCTs:
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
5
Hybrid
 Traditional site visits as well as
remote telehealth or in-home visits.
 Drug supply is usually done during
scheduled on-site visits.
• Remote and on-site assessments
Full
 Remote telehealth visits with no on-
site consultations
 Direct-to-patient drug supply
 Remote assessments through
wearables and devices
 Remote sample collections

6. Requirements for DCTs:
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
6

7. Process:
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
7

8. Benefits of DCTs:
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
8
More cost-effective.
Less frequent travel, automated data
collection.
Elimination of source document
verification.
Reduced site burden.
Patients with mobility issues can
participate.
patient-centric approach.
Enhanced recruitment, not limited to
geographical locations, travel
implications, and time constraints.
DCTs

9. Challenges:
A great understanding of digital ecosystem is required.
Generally effective with the young population
Cost of new software
Patient concerns over sensitive data on the internet
Trials Sponsors must invest in sophisticated technology
Some areas of clinical research not ready for remote monitoring.
Research sites being left out of the trial process.
Diseases that require in-hospital monitoring are not appropriate for this
approach
Choosing the right technology
Clinical research staff and participants learn new technology.
Limited validation of novel digital outcome measures
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
9

10. Case studies:
 Pfizer’s REMOTE
• Research on Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE) with
Tolterodine was conducted in 2011.
Main goal: Validation—to compare it to a conventional Phase IV clinical study to determine if the
virtual trial design would be a feasible way to conduct future trials.
 Sanofi's Virtual Diabetes Trial
• In 2015, Sanofi announced its intention to conduct a virtual diabetes trial named VERKKO.
• The first clinical trial using electronic informed consent to be approved by the 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.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
10

11. Future of DCTs:
In the last few years, there has been a dramatic increase in telemedicine, remote diagnoses, and prescribed treatment.
• The pandemic has propelled decentralized clinical trials (DCTs) into the mainstream, and multiple enterprises have transitioned to the virtual model for
conducting clinical trials. Both enterprises and DCT vendors have stated that improved patient experience is the biggest benefit of the decentralized model.
• As digital technologies become more widely incorporated into clinical trials, the EU’s regulatory framework for DCTs and hybrid trials will need to evolve to
incorporate digital data, emerging digital endpoints, and modernized Good Clinical Practice (GCP) protocols.
• 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.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
11

12. Conclusion:
Patient centricity is a priority for all stakeholders, and the DCT model can achieve this. With the industry’s ongoing
emphasis on effectiveness and timelessness, virtual trials will become an important part of clinical research.
• Functionality requirements need to be considered when selecting the EDC or DCT platform; not one size fits all.
• Trials complement certain study designs but do not fit all therapeutic areas.
• Licensing and validation timeframes can play a big role in DCT database design and release to production.
• Close collaboration between data management and clinical operations is now more important than ever.
• Regulators agree that DCT approaches can be considered for various types of trials, provided that the decentralized
elements are justified considering the research question and trial characteristics.
The 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.
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
12

13. References:
• Gaba, P., and Bhatt, D.L., The COVID-19 pandemic: a catalyst to improve clinical trials. Nat. Rev. Cardiol. 17, 673–
675 (2020).
• Fogel, D.B. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a
review Contemp. Clin. Trials Commun. 11, 156–164 (2018)
• Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division,
and National Academies of Sciences, Engineering, and Medicine Virtual Clinical Trials: Challenges and Opportunities:
Proceedings of a Workshop (National Academies Press, Washington, DC, 2019)
• FDA Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, 33 (2021)
• Santa-Ana-Tellez, Y. et al. Decentralized, patient-centric, site-less, virtual, and digital clinical trials? From confusion to
consensus Drug Discov. Today, 28, 1–8 (2023).
• Clinical Trials Transformation Initiative Decentralized clinical trials, 2018. https://www.ctti-
clinicaltrials.org/projects/decentralized-clinical-trials. Accessed August 13.
• https://www.linkedin.com/pulse/decentralized-clinical-trials-future-research-abhishek-pitti-md/
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
13

14. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
14