Clinical Trial Platform Overview Modern clinical trials employ various digital-based tools and technologies designed to increase the speed, accuracy, and ease of conducting clinical trials. In the best-case scenario, these tools are housed in the same experience or a “clinical trial platform.”
Clinical trial platforms are software-based, web-based, and/or cloud-based solutions that facilitate clinical trial research throughout its entire lifecycle. They offer a complete technology ecosystem that connects patients, research sites, and trial sponsors from patient recruitment to close out and data submission. Users of clinical trial platforms can access and operationalize all of their digital-based tools through this connected platform. Platforms can prevent users from accessing parts of the platform not permitted for them. For instance, participants can not view other participants' data or gain access to tools meant for sites. Other users, like sponsors’ study teams, have access to the full suite of tools as needed based on their roles.
At their core, these platforms help connect, collect, display, and steward clinical trial data, offering convenient access for users. The best platforms are system agnostic, enabling users to connect their trial platform to their existing clinical trial ecosystem.
They include electronic patient-reported outcomes (ePRO) and clinical outcome assessment (eCOA) modules for data collection, as well as electronic informed consent (eConsent), virtual training, live chat, telehealth, and more. They may employ intelligent automation , machine learning, artificial intelligence, and other technologies as needed.
The benefits of clinical trial platforms are many. They can enhance transparency around study protocols, help recruit a more diverse participant pool, and remove barriers to trial participation, such as travel requirements. They can streamline data collection, support patients in real time, improve patient engagement and retention, and enable participation from home, which is particularly beneficial for certain disease states. Ultimately, these platforms can lead to better data quality, producing richer and more accurate data through streamlined data collection and real-time monitoring, supporting meaningful outcomes in clinical research.
Clinical trial platforms also help facilitate efficiency offering collaborative tools for streamlined communication. Platforms may also facilitate patient concierge services for personalized support, medical record review services for efficient patient screening, and drug/device provisioning to ensure participant access. Remote clinical research associate (CRA) services for virtual site monitoring are also common.
Things to look for in a clinical trial platform can include a user-friendly interface with multilingual support, single sign-on for convenience, robust data security and privacy features, and scalability across diverse geographic regions and therapeutic areas. Additional features may include patient engagement tools, real-world data collection and analysis capabilities, DCT analytics tools for tracking key performance indicators (KPIs), and home nursing services for additional patient support.
Clinical Trial Platform capabilities On April 25, 2023, the Decentralized Trial Research Association (DTRA) released a comprehensive patient map outlining the key steps that a participant faces throughout an oncology trial.
It’s through this framework that we can view the capabilities of a clinical trial platform.
Decentralized Trial Research Association's (DTRA) comprehensive patient map outlining the key steps that a participant faces throughout an oncology trial.
Clinical trial platforms should have capabilities that help facilitate:
A connected trial environment that facilitates trial conduct, data collection, and communication between participants, sites, and sponsors’ study teams Participant pre-screening Participant informed consent Participant engagement of participation and compliance Data collection, analysis, and stewardship Audit support Data closeout
Connected trial environment Digital clinical trial platforms create a central hub for all those involved in a study. This connected environment allows for smoother running of the trial itself, data collection, and communication between participants, research sites, and the sponsor's team. Imagine a secure online space where participants can access study information, report data electronically, and connect with the research staff for questions. Meanwhile, the sites and sponsors can monitor progress, share updates, and ensure data quality – all within the same platform. This streamlined approach can foster better collaboration and information flow, ultimately benefiting the entire clinical trial process.
Participant pre-screening Clinical trial platforms offer a way to pre-screen patients for studies electronically. Participants complete online questionnaires using computers, smartphones, tablets, on-site, etc., answering questions about their health history, medications, and daily routines. The platform then compares their answers to the specific requirements for the clinical trial.
Digital pre-screening streamlines the process by more quickly identifying potential matches, this saves time and prevents researchers from interacting with unqualified candidates.
You can learn more about patient screening with our complete guide, here.
Participant informed consent Clinical trial platforms can enhance the informed consent process for participants with the use of electronic informed consent (eConsent). eConsent is becoming a more common way of completing the informed consent process.
Here, the eConsent tool sits within the platform itself. Instead of lengthy paper documents, the platform can present information in a clear and interactive format. This might include bite-sized explanations, videos, and illustrations that explain the study's goals, procedures, and potential risks and benefits. Participants can then review the information at their own pace and revisit specific sections if needed. The platform can also make it easier to ask questions and get clarification directly from the research team before providing electronic consent. This approach allows for a more thorough understanding of the study, potentially leading to more informed decisions about participation.
You can learn more about informed consent with our complete guide, here.
Participant engagement and compliance Clinical trial platforms can act as a valuable tool for keeping participants engaged and compliant throughout the study by deploying electronic clinical outcome assessments (eCOAs) or electronic patient-reported outcomes (ePROs). eCOA and ePROs offer features that make participation easier and more convenient. For example, participants might receive automated reminders for appointments or medication schedules, as well as educational materials and updates about the study's progress through their ePRO.
Participants can also report symptoms or ask questions directly from their smartphone or computer. This two-way communication fosters a sense of connection with the research team and helps ensure participants have the information and support they need to stay actively involved in the trial.
To learn more about eCOA and ePRO, click here to read through our complete guide.
Sites and study teams can better view which participants are compliant with the study by using the platform's reporting and dashboard features, enabling quicker outreach to discuss any issues.
Data collection, analysis, and stewardship Clinical trial platforms act as a central hub, drawing data from a multitude of sources such as the tools mentioned above in pre-screening, eConsent, eCOA, and ePRO. However, they also can collect data from more novel data streams like telehealth consultations, wearable device readings, and remote patient monitoring systems.
Here, the platform acts as an orchestrator, compiling the data from sites, participant diaries and connected devices, digital measures, and more while presenting it in viewable and digestible formats.
Consolidated trial views such as dashboards help researchers quickly understand enrollment rates, participant demographics, and adherence to treatment protocols. Reporting tools help leverage advanced analytics to identify trends and uncover potential issues early.
Audit support Clinical trial platforms can significantly improve a site's and study team's preparedness for these audits, fostering a smoother and less stressful experience. Because platforms are all digital, they can better document data, processes, user actions, etc., by automatically recording each action a user performs within the platform.
Platforms offer a centralized location for all study documents, including protocols, investigator brochures (IBs), and informed consent forms (ICFs). This eliminates the need for paper-based filing systems, making it easier for auditors to locate and review required documentation. Additionally, the platform ensures version control, preventing confusion over outdated documents.
Platforms automatically track all data entry and modifications, creating a clear audit trail for every piece of information. This allows auditors to easily reconstruct the chain of events and identify any potential inconsistencies. Furthermore, platforms can generate comprehensive reports that summarize key data points, saving auditors and study teams valuable time.
They also often have built-in compliance features. These features can alert study teams to upcoming deadlines for regulatory filings or highlight potential protocol deviations. By proactively addressing these issues, platforms can help minimize the risk of non-compliance findings during audits.
Manual data entry can be prone to errors, which can become a major concern during audits. Clinical trial platforms automate many data collection processes, minimizing human error and ensuring data accuracy. This not only improves data quality but also reduces the likelihood of discrepancies that could trigger audit queries.
Lastly, platforms provide a central communication hub for study teams, sponsors, and auditors. This allows for real-time information sharing and facilitates collaborative responses to audit inquiries. Improved communication fosters a more transparent and efficient audit process for all parties involved.
Data closeout Platforms can automate data cleaning procedures, eliminating inconsistencies and missing entries. This reduces the manual effort required for data verification and ensures the accuracy of the final dataset. Built-in validation rules can further identify potential errors before data lock, preventing delays during closeout.
The centralized nature of clinical trial platforms simplifies data tracking throughout the study. Researchers can easily identify any outstanding data collection or missing information for individual participants. This facilitates timely reconciliation and ensures all necessary data points are captured for analysis.
Platforms can automatically generate standardized reports required for regulatory submissions. This not only saves time for study teams but also reduces the risk of errors associated with manual report creation. The platform can also ensure all regulatory requirements are met, preventing delays during the closeout process.
Data closeout often involves managing multiple versions of datasets. Clinical trial platforms provide comprehensive version control, allowing researchers to track changes and revert to previous versions if necessary. Additionally, detailed audit trails document all data modifications, ensuring transparency and facilitating potential future audits.
Platforms offer secure and compliant options for archiving the final dataset according to regulatory guidelines. These options ensure the long-term accessibility and integrity of the data for future analysis or regulatory inquiries.
Benefits of a Connected Digital Ecosystem for Clinical Trials Clinical trial platforms powered by a complete digital ecosystem and decentralized elements can offer benefits beyond that of traditional research methods.
For Patients: Enhanced Accessibility, convenience, and engagement: Decentralized trials eliminate geographical barriers, allowing patients from diverse locations to participate remotely. This helps keep them better engaged and makes participation far easier for those in rural areas, with limited mobility, or facing logistical challenges.Reduced Burden and Improved Quality of Life : By minimizing the need for frequent in-person visits, decentralized trials reduce the burden on patients. Additionally, wearable devices can continuously monitor health parameters, providing valuable data without requiring additional effort from participants.For Sponsors: Faster Recruitment and Enrollment: The wider reach of decentralized trials allows sponsors to tap into a larger pool of potential participants, accelerating recruitment and enrollment timelines.Increased Data Quality and Real-world Insights : Digital tools capture real-time, real-world data, providing a more comprehensive picture of a participant's health and response to treatment. This can lead to more robust and generalizable study resultsReduced Costs and Improved Efficiency: The streamlined nature of decentralized trials reduces expenses associated with travel, site maintenance, and administrative tasks. This translates to significant cost savings and improved overall research efficiency.
For Clinical Research Sites: Reduced Administrative Burden: Clinical trial platforms automate many administrative processes, freeing up valuable staff time for patient care and study oversight.Enhanced Safety Monitoring: Digital tools allow for continuous monitoring of participant health data, enabling earlier detection of potential safety concerns. This ensures participant well-being and promotes proactive intervention if needed.Increased Investigator Productivity: Streamlined workflows and centralized data management within the platform empower investigators to focus on core research and participant activities, enhancing their productivity.
Overall Benefits: Faster Development of New Treatments: By streamlining the research process and improving efficiency, decentralized trials connected through a digital ecosystem accelerate the development of new therapies, ultimately benefiting patients in need.More Diverse and Representative Patient Populations: The wider accessibility of decentralized trials allows for participation from a broader range of demographics, leading to more generalizable research findings that benefit a wider population.Enhanced Transparency and Trust: Digital platforms can facilitate open communication and data sharing between stakeholders, fostering transparency and trust in the research process.
In conclusion: The development and rise of clinical trial platforms marks a significant leap forward in clinical research. These comprehensive ecosystems empower faster, more efficient, and more inclusive clinical trials.
By connecting all stakeholders, streamlining data collection, and fostering real-time communication, clinical trial platforms pave the way for the development of life-saving treatments at an accelerated pace.
As technology continues to evolve, we can expect even more innovative features and functionalities to be integrated into these platforms, such as advanced AI, automation, etc., further revolutionizing the future of clinical research and, ultimately, bringing more treatments to patients faster.
To see the capabilities of Medable’s clinical trial platform, click here.
