Clinical Trial Approval System
Note: This is a case study of work done by Sam Rojas at a consulting firm. It does not depict work produced independently by ROJI Design. The images used here are scrubbed re-creations of designs for reference and do not represent the entire completed project.
In addressing the complex landscape of clinical trial approval, a team embarked on a project to design a user interface for a clinical trial matching engine. The objective was to leverage statistical output to create a richer experience for pharmaceutical professionals tasked with evaluating and approving potential patients for clinical trials.
Project Plan
The primary goal was to design a user-friendly interface that allows clinical trial approvers to efficiently review and act upon percentage scores generated by the matching engine. This required a deep understanding of the clinical trial approval process and the ability to translate it into an intuitive digital experience.
Role and Responsibilities
As the principal designer, Sam's responsibilities extended from conceptualizing the user interface to swiftly delivering a set of screens that depicted the entire clinical trial approval process. With no direct communication with end-users, UX-informed decisions played a crucial role in shaping the design of the product.
Design Process
The design for the clinical trial approval systemwas guided by a set of requirements for features planned to be showcased to a pharmaceutical client. The primary feature was the work of a clinical trial matching engine whose analysis of clinical trial interest questionnaires provides a richer experience for clinical trial operators approving candidates for trials.
Design and development worked near parallel to deliver this product demo. The designed screens were quickly handed over to a specialized development team working with Oracle Apex—with the intent for the design to be flexible enough to live within other platforms like Salesforce.
Understanding the Workflow
Comprehending the intricacies of the clinical trial approval workflow was the initial challenge. This involved surveying the journey from the perspective of two personas: a user registering for a clinical trial and the clinical trial operator making approval decisions based on the engine-generated scores. The information entered by the potential patient would be processed by the trial matching engine to produce a set of scores for the operator. While the scores guided the operator towards making an informed approval decision, the system should allow them the ability to ask the potential patient questions to further illustrate any unclear or insufficient responses. Understanding the hand-off between both the internal clinical trial approval system and the patient-facing clinical trial portal was key to the product pitch, ensuring that the design would fit within existing workflows and platforms used by the client.
Conceptualization
Having an established design system sped up the conceptualization of the product, allowing for a plug-and-play approach to meeting design requirements using established components—tables, buttons, cards, and filters all had proper design documentation. Oracle APEX having its own design system meant finding the middle ground between the two to allow for the experience to be guided by the client's UX guidelines while leveraging out of the box components.
Design Execution
For the potential patient experience, additional screens were designed to support additional questionnaire that would be processed by the matching engine. As an enhancement to the current registration experience, this allows for a deeper level of understanding about the user's experience with selected medical conditions and provide detailed information to the operator.
The designs for the clinical trial experience allow the operator to address patients pending approval, viewable either as a full list or grouped by trial. Clicking into a patient's information—scrubbed at this point of the experience—provides the operator with scores generated by clinical matching engine. Each patient is scored for inclusion and exclusion criteria, noting how many of the additional questions support their compatibility with a clinical trial. From this screen, the operator is able to send anonymous questions to the potential patient to gather more information and make a final approval decision for the patient's inclusion in a clinical trial. The patient would then proceed through a current workflow for approved patients. The design of the clinical trial approval system provided a valuable addition to the
Final Outcome
Through informed design decisions and collaboration with a dedicated development team, the resulting interface streamlined the clinical trial approval process and proved adaptable for broader industry applications. Reflecting on the project, the reliance on UX principles and rapid decision-making underscored the importance of adaptability in scenarios where direct user feedback is limited. The positive reception and subsequent adaptations for other clients affirmed the effectiveness of the design approach. The absence of direct communication with users or stakeholders presented a challenge. However, informed by UX principles, the design decisions aimed to create an interface that prioritized clarity, efficiency, and ease of use.
The culmination of the project was a video presentation showcasing the end-to-end user experience, starting from user registration to the clinical trial approver's actions. The designs not only met the client's expectations but also proved versatile, being adapted for use with other pharmaceutical clients. The designed interface was well-received, demonstrating its value in streamlining the clinical trial approval process with the inclusion of matching engine generated scoring. The success of this project paved the way for its adaptation and restructuring to meet the needs of other pharmaceutical clients.
