Selecting the right vendor, solution, and deployment model is crucial for the successful implementation of eCOA technology in clinical research. Customisation is key to meet the unique needs of sponsors, site staff, and patients, ensuring secure data collection with minimal disruption. Many sponsors may be unsure about what to look for in an eCOA platform, how to align features with study requirements, and the necessary training and support for a seamless user experience. Without proper planning and the right vendor, there is a risk of unexpected delays, patient dissatisfaction, staff frustration, and unnecessary costs.
The value of eCOAs:
End users, including patients and site staff, expect technology to seamlessly integrate into their daily lives, offering a personalised and user-friendly experience. This expectation extends to eCOA. To ensure regular engagement with these platforms, sponsors should prioritise intuitive and data-protected technology. However, participants are often excluded from the selection process. Hence, the teams in charge of selecting the eCOA platform must prioritise advocating for the needs and preferences of all users and take into consideration the following:
- Customisation for patients: Selecting an eCOA solution that caters to the unique needs of each patient population is crucial. The sponsor’s team should gather real-world data on patients’ experiences with the disease and treatment to ensure a positive patient experience. Factors such as motor skills, memory issues, neurological conditions, and sensitivities should be considered. Technology selection should account for the patients’ ability to comfortably use devices and any potential sensitivities. Additionally, sponsors should assess patients’ openness to using new devices or a bring your own device (BYOD) approach. Infrastructure availability, trust, and data access should also be evaluated to enhance engagement, retention, and compliance.
- Simplified workflow for site staff: The needs of site staff should not be overlooked when evaluating eCOA technology. Site staff play a critical role in reviewing assessment results, ensuring completion rates, and transferring data. The selected technology should be simple, easily accessible, and require minimal interaction. Prioritising workflow speed and simplicity allows site staff to focus on patient care and study protocols. Quick and effortless creation of patient profiles, monitoring individual or group statuses and easy access to compliance rates are essential for efficient workflow management.
- Data portability: Sponsors must ensure secure and efficient extraction of data from the eCOA platform. Data security and privacy measures should be thoroughly assessed at every touchpoint. Seamless data transfer through APIs, without human intervention, ensures data is sent to the destination system without additional logins or interactions. Such integrations minimise technical data tasks for site staff and ensure fast and consistent data delivery, while adhering to privacy regulations.
Best practices for assessing eCOA technology solutions
When evaluating eCOA technology solutions, sponsors should consider various factors to make the best decision for their trials. It goes beyond assessing patient needs, site staff requirements, and data considerations. Other aspects such as timing, testing, and vendor support can significantly impact successful deployment.
Deploying an eCOA platform may extend the trial timeline, depending on technology, customisation needs, and training requirements. Sponsors should plan ahead and engage with vendors who can expedite deployment, ensuring a seamless user experience from the trial’s outset. Acting promptly is crucial, particularly for smaller sponsors with limited resources. Having a pre-existing eCOA system in place, working with a trusted technology vendor, allows study teams to focus on other critical start-up tasks and ensures a positive initial interaction for patients with the trial technology.
There are seven best practices for sponsors to consider when making eCOA technology decisions:
- Ensure compliance with data privacy and security regulations: When implementing an eCOA platform, it is crucial to verify that the platform meets all regulatory requirements for data privacy and security, especially for global trials where diverse rules govern data collection, transmission, sharing, and storage.
- Seamless integration with existing trial systems: Select a platform that seamlessly integrates with existing trial systems to reduce the number of systems site staff must navigate and facilitate sponsors’ access to data.
- Gather input from site staff: Seek input from site staff, leveraging their past experiences with eCOA platforms to identify preferred and disliked features when assessing vendors.
- Conduct user acceptance testing (UAT): Allocate time for user acceptance testing (UAT) to ensure that assessments function as intended across different operating systems and meet the assessment’s objectives during every interaction. Additionally, consider vendors offering pre-built APIs and pre-validated assessments for accelerated deployment.
- Maintain data control: Maintain complete control over the data, enabling sponsors to access and retrieve it as needed for the study.
- Establish dedicated point of contact: Establish a dedicated point of contact, such as a project manager, who will address issues, provide support, and ensure the technology operates as expected.
- Evaluate training materials: When evaluating training materials, consider factors such as accessibility, duration, and comprehensiveness. End users, including site staff and patients, prefer user-friendly platforms with minimal training requirements and infrequent updates.
Staying prepared
eCOA technology holds immense promise for improving clinical research efficiency and effectiveness. Sponsors can select eCOA platforms that align with their trial objectives and improve the overall trial experience by considering the key factors outlined.
The continuous evolution of eCOA technology is likely to bring even more advancements in the future, including improved customisation options, seamless integration with existing trial systems, improved data privacy and security measures, and user-friendly interfaces. Sponsors should remain informed and incorporate these developments into their decision-making processes as they develop. By embracing the potential of eCOA technology and implementing best practices, sponsors can propel the future of DCTs, ultimately benefitting patients, site staff, and the research community as a whole.
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Course Required Courses ENGL-450
Free & Open Source Culture
IGME-582
Humanitarian Free & Open Source Software Development
This course provides students with exposure to the design, creation and production of Open Source Software projects. Students will be introduced to the historic intersections of technology and intellectual property rights and will become familiar with Open Source development processes, tools and practices. They will become contributing members of humanitarian software, game and interactive media development communities. Students will actively document their efforts on Humanitarian Free and Open Source Software community hubs. (Prerequisites: This class is restricted to students with at least 2nd year standing.) Lec/Lab 3 (Spring).
Electives Choose one of the following: COMM-303
Small Group Communication
This course provides students with opportunities to engage in small group decision making and problem solving. Students will analyze and evaluate their own experiences and relate them to theories and research from the field of small group communication. Lecture 3 (Fall or Spring).
COMM-304
Intercultural Communication
Intercultural communication provides an examination of the role of culture in face-to-face interaction. Students may find a basic background in communication, anthropology, or psychology useful. Lecture 3 (Fall or Spring).
ENGL-215
Text & Code
We encounter digital texts and codes every time we use a smart phone, turn on an app, read an e-book, or interact online. This course examines the innovative combinations of text and code that underpin emerging textual practices such as electronic literatures, digital games, mobile communication, geospatial mapping, interactive and locative media, augmented reality, and interactive museum design. Drawing on key concepts of text and code in related fields, students will analyze shifting expressive textual practices and develop the literacies necessary to read and understand them. Practicing and reflecting on such new media literacies, the course explores their social, cultural, creative, technological, and legal significance. To encourage multiple perspectives on these pivotal concepts of text and code and their import, the course includes guest lectures by scholars and practitioners in these fields. Lecture 3 (Fall).
ENGL-581
Intro to Natural Language Process
This course provides theoretical foundation as well as hands-on (lab-style) practice in computational approaches for processing natural language text. The course will have relevance to various disciplines in the humanities, sciences, computational, and technical fields. We will discuss problems that involve different components of the language system (such as meaning in context and linguistic structures). Students will additionally collaborate in teams on modeling and implementing natural language processing and digital text solutions. Students will program in Python and use a variety of relevant tools. Expected: Programming skills, demonstrated via course work or instruction approval. Lecture 3 (Spring).
ISCH-201
Computing, Culture, and Society
This course is designed to introduce students to the social impacts of computing technology. The course will provide a brief introduction to ethics and to the history of computing and the Internet. It will focus on a number of areas in which computers and information technology are having an impact on society including privacy, freedom of speech, intellectual property, work, distribution of wealth, algorithmic bias and the environment. Current issues that will be discussed include electronic voting, spyware, spam, and intellectual property issues associated with digital content distribution. Students will be required to demonstrate oral and written communication skills through assignments such as short papers, homework, group discussions, and debates. Computing majors may take this course only with department approval. Lecture 3 (Fall).
STSO-201
Science and Technology Policy
STSO-230
Foundations of Engagement and Community Transformation
Are you passionate about addressing the socially-complex, wicked problems of our time? This course incorporates humanities and social science approaches and counts for general education requirements. Lecture 3 (Spring).
STSO-240
Social Consequences of Technology
Modern society is increasingly based on technology. In this course we study several interactions between technology and the world in which we live. We investigate how various technologies developed and compare the expected effects of the new technologies with the actual results. Lecture 3 (Fall, Spring).
STSO-246
History of Women in Science and Engineering
Using biographical and social-historical approaches, this course examines the history of women’s involvement in science and engineering since the birth of modern science in the seventeenth century; the historical roots of gender bias in the Western scientific enterprise; and the influx of women into science and engineering since the mid-to-late 20th century. Cross-listed with women’s and gender studies. Lecture 3 (Spring).
