Decentralized clinical trials (DCTs) offer numerous benefits, but they also come with certain challenges. Often, multiple contract research organizations (CROs) participate simultaneously in these trials. This arrangement allows for better data collection and utilization. However, it also presents risks in terms of data compliance and harmonization.
To tackle these challenges, it’s crucial to choose consistent digital tools. For example, implementing a single electronic Trial Master File (eTMF) system to manage CRO participation in decentralized trials can enable each CRO to adapt their contributions as needed while maintaining data harmonization and ensuring compliance across all clinical trial documentation.
Data Compliance and Harmonization Demands for Clinical Trials
Data compliance and harmonization are key aspects of successful clinical trials. The usability of trial data depends on its interoperability within its data set and with other data sources, as well as the integrity of the collected data.
Achieving consistent compliance can be challenging due to varying definitions and interpretations of compliance and regulatory requirements among different stakeholders, including CROs, sponsors, and regulatory authorities.
“There can be different definitions or understandings by CROs, sponsors, and ethics-/regulatory- competent authorities. Harmonization will be essential to resolve PI [principal investigator] concerns in this regard,” writes Kamilla Posselt, Senior Director, DCT Strategy and Innovation, Digital and Decentralized Solutions, PPD, part of Thermo Fisher Scientific.
Harmonization must extend to data collection and maintenance to ensure the adoption of DCT technologies. “ … [R]egulatory uncertainty and lack of regional harmonization were the top roadblocks to the adoption of decentralized clinical trial (DCT) technologies,” writes Pamela Tenaerts, Medable’s Chief Scientific Officer and former Executive Director of the Clinical Trials Transformation Initiative, referencing a 2021 CTTI study.
Even when a DCT is run by a single CRO, issues can arise in generating, maintaining, storing, and analyzing data — both in compliance with applicable regulations and in a manner that generates high-quality data for use by current and future researchers. When several CROs are involved, these challenges can proliferate.
Multiplying CROs Means Multiplying Challenges
The decentralization of clinical trials brings about various challenges, particularly in determining how, where, and by whom data is collected, stored, protected, and maintained.
Other factors contribute just as heavily to a DCT’s success. “The feasibility and quality of DCTs depends on several requirements including dedicated infrastructures and staff, an adequate regulatory framework, and partnerships between research sites, patients and sponsors,” write Carlo Petrini and fellow researchers in a 2022 article in Frontiers in Public Health. These partnerships may include not only research sites and sponsors but also one or more CROs.
Recognizing the importance of DCTs, the U.S. Food and Drug Administration (FDA) has released draft regulatory guidance that promotes the use of digital tools for decentralization in specific situations, such as collecting patient consent information and using telemedicine for follow-up visits.
“We see the agency’s move toward promotion of DCTs as a historic sea change that will lead to major changes in how clinical research is conducted in the U.S.,” write Blake Wilson and fellow lawyers at Hogan Lovells.
While federal level support is critical, effective decentralized trials that meet data compliance demands and harmonize data collection require a comprehensive regulatory framework. Compliance demands in clinical trials focus on the completeness and accuracy of collected data. The FDA’s draft guidance and other regulations provide the concrete boundaries necessary to create and apply compliant, harmonized systems.
An “adequate regulatory framework,” as Petrini et al. put it, typically includes compliance demands focused on the completeness and accuracy of collected clinical trial data. When multiple CROs are involved, aligning everyone’s understanding and approach to data documentation and entry is crucial. Participating CROs must adhere to compliance requirements and effectively track documentation using a clinical trial’s TMF system.
To address the compliance and harmonization challenges in decentralized trials, utilizing powerful tools is essential. An eTMF system provides a centralized platform for data collection, compliance, and harmonization efforts.
Tools to Streamline and Harmonize Decentralized Trial Data
When it comes to addressing compliance and harmonization of data in decentralized trials, there are various individual data-related issues that need to be considered, Pritibha Singh and fellow researchers write in a 2023 article in Clinical Pharmacology & Therapeutics.
These include:
- Determining the storage location and method for data.
- Managing user access and controlling that access effectively.
- Ensuring privacy, particularly concerning patient data.
- Maintaining consistency in data entry across patient encounters and other touchpoints.
- Balancing privacy and security while meeting the need for immediate access as required by regulatory authorities.
Data compliance and harmonization are closely connected to ethical concerns in decentralized clinical trials (DCTs), as highlighted by Petrini et al. Harmonization enhances data integrity and can contribute to maintaining integrity throughout the entire process of data collection, transmission, and analysis. Data compliance plays a vital role in protecting patient health data and improving the integrity of the data set.
To effectively manage data collection, compliance, and harmonization efforts in DCTs, a robust electronic Trial Master File (eTMF) system can be instrumental.
Within an eTMF system:
- A single, secure location for data storage can be identified immediately, ensuring all work conducted within the eTMF is centralized.
- Role-based access controls (RBAC) can be implemented, granting team members access only to the information they require. In case of compromised credentials, unauthorized parties won’t have access to the entire system.
- Privacy controls can be integrated to protect patient identifiers while maintaining the usability of non-individually identifiable data points.
- The system can provide a consistent set of forms and documents, simplifying data entry by ensuring that team members follow the same format each time. Automation features can also flag empty fields or incorrect data formats.
- Access logs are generated in real-time, allowing regulators to monitor the management of information within the eTMF. They can track which team members accessed the system, the documents they interacted with, and the actions they performed. These logs include timestamp information for accurate tracking of changes.
Combining the efforts of multiple contract research organizations in a single clinical trial can be challenging. However, it also enhances the value of the collected and analyzed data. To achieve maximum benefits while meeting compliance and harmonization demands, it is advisable to choose an eTMF system, such as eTMF Master. This solution enables each CRO to gather the specific information required within a unified, secure, and harmonized data storage environment.
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