Transitioning to Decentralized Data Collection (DDC) for Site Burden Reduction

Clinical trials have traditionally relied on centralized data collection methods, where participants visit specific sites for data capture. This approach often places a significant burden on study sites, leading to resource constraints, logistical challenges, and potential delays. Decentralized Data Collection (DDC) offers a promising alternative by utilizing digital health technologies to collect data remotely. This shift not only alleviates the burden on sites but also enhances participant convenience and engagement, potentially accelerating trial timelines and improving data quality.

1. Welcome TRANSITIONING TO DECENTRALIZED DATA COLLECTION FOR SITE BURDEN REDUCTION S hainitha bajjuri Pharm. D 051/052024 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Introduction Decentralized clinical trials (DCTs) Types of DCTs Workflow of decentralized clinical trials Decentralized data collection What is site burden? Impact of site burden on clinical trials Site burden reduction with decentralized data collection Challenges in opting decentralized data collection Conclusion 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 2

3. Introduction Decentralized data collection is the process of clinical data collection from patients remotely. The decentralized data collection is accelerated with technologies and processes that support engagement with patients rather than in-person visits. In a centralized trial subjects participate in number of face-to-face appointments with clinician where data is manually entered into database or captured on paper in multiple places and multiple times and processes are repeated, creating redundancy and introducing a greater chance for inaccuracy. Site burde n is the major issue that pull back the efficiency of clinical trials resulting in increasing trial timelines. One of the most important applications of decentralization is to prevent or minimize site burden which is a matter of concern. Decentralized data collection reduces site burden and streamlines data collection and management efficiently. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 3

4. Decentralized clinical trials (DCT) In decentralized clinical trial some or all of the clinical trial activities occur at locations other than traditional clinical trial site. The alternate locations can be the patient’s home or local healthcare facility or local lab. DCTs often incorporate digital health technologies (DHTs), which are systems that capture health care information for the clinical trials directly from individuals. Some of the DHTs- Portable trackers (glucose monitors, BP monitors). Devices with sensors which can be wearable, implantable or ingestible. Mobile applications to rate pain, depression, daily functioning, quality of life and can track functional performance such as cognition, coordination, vision, daily functioning. Patient engagement platforms like chatbots 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Types of decentralized trials Hybrid trials Integration of traditional clinical visits and remote or virtual methods which are facilitated by digital health technology. Subject may visit for initial screening, for signing consent form, for a few visits, if necessary. Allow participants to take part remotely in some activities while also having chance to interact with study staff in person. Full decentralized trials Virtual trials conducted using digital health technology platforms. Participants are not needed to visit trial site, starting from subject recruitment to till data collection and monitoring, everything will be virtually managed. Offers greater convenience and increases the patient retention. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 5

6. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 6 Minimal or no screening is required as most of the trial matching is done through existing EMR data. Data is acquired through wearables, trackers, lab data from the local lab or nearby health facility, carers, nurses or healthcare assistants can visit participant’s home to aid in vitals or overall performance tracking. All the data is tracked and managed by central secure database. Workflow of decentralized trials Fig-1: Steps involved in decentralized trials source

7. Decentralized data collection 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 7 Fig-2: Various data sources in decentralized data collection

8. What is site burden in clinical trials? The summary of challenges that research sites face during the study is referred to as site burden. The increase in protocol complexity and the resulting rise in effort required by trial site for execution of clinical research studies. Site challenges: Patient recruitment and enrollment Long study initiation timelines Patient access challenges Site staffing and retention Complexity of clinical trials Physical interest and engagement Technology Trial financial management 15/06/2024 www.clinosol.com | follow us on social media @ clinosolresearch 8

9. Impact of site burden on clinical trials Site burden negatively affects the productivity and efficiency of clinical trials: Patient recruitment and retention are critical, as low enrollment rates can lead to delays and increased costs, while high dropout rates compromise data quality. Ensuring patient diversity, effective collaboration with sponsor and CRO, promptly reporting adverse events are additional hurdles. Public health emergencies can disrupt trials, necessitating swift adaptation to maintain participant safety and trial integrity. Reducing clinical trial site burden is essential for enhancing efficiency, improving study outcomes and ensuring the successful completion of clinical trials. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 9

10. Site burden reduction with decentralized data collection Implementing decentralized trials can significantly reduce the logistical and operational burden on sites making trials more accessible to participants and allowing sites to manage their resources more effectively. Centralized CTMS alleviate site burden by streamlining study tasks and documentation (centralized data entry- EDC/DDC, real-time monitoring, seamless communication between study teams, reducing administrative workload on site staff.) Digital technology for patient recruitment, enrollment through eConsent , trial matching through EMR/EHR. Standardized workflows with simplified documentation. Reduction in time to focus on source data verification (SDV). Diversified patient population from different geographical areas which is supported by remote monitoring. Digital health technologies (DHTs) for vitals tracking, monitoring adherence to IP, lab data, AE reporting reduces burden on site and staff as most of the trial activities are carried-out at patient’s home or local lab or local healthcare facility. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 10

11. Challenges in opting decentralized data collection The collection, management and interpretation of data from new sources and in new forms is one of the greatest challenges DCTs pose for clinical teams. Analyzing required, unwanted data from large volume of data produced. Data cleaning is tedious when unstructured data is produced from wearables. Need to create new algorithms or update existing algorithms to facilitate the filtering of essential data from the raw data being produced. Integrating data collection and analysis systems. Pre-planning, risk identification and mitigation is required in case of server issues, system upgrades, data migration, updates to data point according to protocol amendments. Recognizing limitations within vulnerable patient populations (pediatrics, geriatrics, rare diseases). Data mapping and data standardization. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 11

12. Conclusion Site burden reduction is quite challenging and has been a factor that reduces the efficiency and quality of the trials being done. Various methods will be opted to reduce site burden and improve the quality and to reduce trial timelines. Decentralized data collection is one of the most promising techniques that could reduce site burden efficiently but has its own disadvantages. Other strategies include- simplifying and standardizing workflows and processes, identifying the gaps, establishing clear communication and transparency at the site, adopting a quality management system to ensure regulatory requirements are met. As the technological advancements happen it is best to follow decentralization but implementation of certain strategies is important to mitigate challenges with data collection and management. 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 12

13. Reference https://www.fda.gov/drugs/cder-conversations/evolving-role-decentralized-clinical-trials-and-digital-health-technologies#:~:text=In%20a%20decentralized%20clinical%20trial,facility%2C%20or%20a%20nearby%20laboratory . de Jong AJ, van Rijssel TI, Zuidgeest MGP, van Thiel GJMW, Askin S, Fons-Martínez J, De Smedt T, de Boer A, Santa-Ana-Tellez Y, Gardarsdottir H; Trials@Home Consortium. Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective. Clin Pharmacol Ther . 2022 Aug;112(2):344-352. doi : 10.1002/cpt.2628. Epub 2022 May 17. PMID: 35488483; PMCID: PMC9540149. https://multiplesclerosisnewstoday.com/traditional-vs-remote-vs-hybrid-clinical-trials-what-you-need-to-know/ https://acrpnet.org/2023/08/top-site-challenges-of-2023-data-and-insights-on-site-burden-and-trial-efficiency-2/ https://www.clinicalleader.com/doc/understanding-data-collection-and-management-in-decentralized-clinical-trials-dcts-0001 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 13

14. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 15/06/2024 www.clinosol.com | follow us on social media @clinosolresearch 14