Recently in August 2022, I worked on a clinical trial management system design project for a job interview for a Senior Product Designer role. The following case study is a documentation of my design research process, findings and artefacts for a product design solution to the 'take home' problem statement during the interview process.
What is 'Safe Trials'?
Safe trials is a decentralised clinical trial management system. A mobile-first experience for patients enrolled in a clinical trial and for researchers from the pharmaceutical firm conducting the clinical trial.
My role
Product Discovery, Product Design, UX Research
Project Type
Take home design problem for a job interview process for a Senior Product Designer role at a B2B SaaS product firm.
Project Timeline
13 August 2022 - 15 August 2022 (3 days)
Safe Trials: Patient Experience
The Patient app will facilitate Patients enrolled in a clinical trial to record their daily medications, schedule doctor appointments and report adverse events through an intuitive chat experience.
Safe Trials: Scientist Experience
The Scientists app will facilitate researchers, and RnD scientists of the sponsor pharmaceutical firm can keep track of upcoming, running and completed clinical trials, get notified about milestone reports, review protocol breaches and adverse events, view and analyse data and access granular level patient data as well.
Design Process
Empathise:
1. Primary Research: User Interviews with industry professionals
2. Secondary research: Competitor Analysis and feature benchmarking
Define: 3. Problem Statement and MVP scope prioritisation 4. System Design Ideate: 5. User journey for a patient and scientist 6. Wireframes
Prototype:
7. Hi-fidelity mockups and UI design 8. Interactive Prototype (TBD) Test:
9. Usability Testing with five users (TBD)
10. Integrate testing feedback (TBD)
1. Primary Research: User Interview for product discovery
A user interview with an industry leader Dr Ajay Khopade (Vice President F R&D at Sun Pharmaceutical Industries Ltd), to understand current practices for clinical trials created the following insights:
Who is involved in a clinical trial?
Sponsor: The pharmaceutical firm carrying out the clinical trial (Scientists, Executives, Auditors)
Sites: Hospital and Clinics (Doctors ad Nurses)
CRO: Contract Research Organisation that the Sponsor firm has hired to carry out the Clinical Trial.
Participants: Patients who have been screened and consented to participate in the clinical research.
QA Compliance team, Auditors from the Sponsor and Site
Good Clinical Practices GCP Monitors
Regulatory authority for authorising drugs
What is the process of a clinical trial?
Protocol for the clinical trial is laid out for stages 1, 2 and 3 before starting stage 1.
Patient Recruitments milestones guide the roadmap and timeline of a Clinical Trial.
Patient incentivisation plays a significant role in reducing dropout rates.
Stage 1: Clinical Trial
This phase of the trial is carried out on healthy individuals. Safety is primary, not drug accuracy.
The following steps of stage 1 are in the following order:
Site Management Protocols
Onboard teams
Protocol on how to investigate patient (method of drug infusion, blood sample frequency)
Site initiation
QA team checks on sites
Screening and recruitment of patients by Site
Protocol Compliance Check by CRO and Site
Collect Pictures of bottles for the proof making of volume administration.
Stage 1 runs for 3–6 months based on drug type, method of administration, patient engagement and dropouts
Stage 2: Clinical Trial
It is carried out on a bigger set of patients.
Decide if the drug will enter stage 2 of clinical trials or not based on product success metrics defined previously in the Protocol (Risk/ Benefit Ratio, Safety Gradations)
Doc will inform the patient about the Protocol and take informed consent.
Protocol-compliant assessment by Doctors.
Sites will incentives patients.
Create Case Report Forms verification by Doctors Screening of Patients > If satisfies Eligibility Criteria Patient Recruitment.
Futility Assessment if early trends show success or failure of the drug in stage 2 according to Protocol.
Stage 2 Runs for 6–18 months based on drug type, method of administration, speed of patient recruitment, patient engagement and dropouts
Stage 3: Clinical Trial
Carried on a big pool of participants from different demographies and medical histories.
Carried on participants dealing with the disease the drug should cure
Interim data monitoring is critical in this stage. Scientists need insights about: True or non-true responders; create insights for trend outliers.
If the drug passes stage 3 is sent to a regulatory authority for approval.
After approval, it goes into production.
Vigilance is an essential job for Clinical trials. If something goes off the course, Regulatory Authority has to be notified.
Touchpoint for RnD scientists and Patients
CRO agency monitors get in touch, not researchers.
Protocol-dependent visits of patients need to be ensured by CRO and Doctors.
Pain Points for a Pharmaceutical company
Low Data Accuracy: Data duplication from paper forms has low confidence.
Low Data Integrity: Casual Monitoring from CROs, Tight schedules of doctors
Patient engagement: Patient dropouts are a big issue caused by low or no formal way of incentivising patients to come for regular visits according to Protocol.
Tracking Protocol Compliance of Sites (Hospitals/Clinics) and Participants(Patients)
Volume administration: There is no way to know precisely if the patient took the right amount of medicines on time
Errors in product labelling, randomisation of patients and drug units.
Payment stalls: The war in Ukraine has caused high dropouts in clinical trials
Clinical Operational and logistics issues
2. Secondary Research: Competitor Analysis
Secondary research on understanding Clinical Trial Management involved the following steps.
Understanding the ecosystem of SaaS solutions competitors offer and defining the solution scope.
Shortlisting Direct and Indirect Competitor landscape of Clinical Trial Management Solutions
Understanding existing SaaS solutions in Clinical Trial Management and Electronic Data Collection.
I researched companies providing a cloud-based decentralised Clinical Trial Management System(CTMS), Clinical Data management Systems(CDMS), Electronic Data Capture(EDC), eConsent and eCRF tools. The majority of these products are focused on use by CROs and Sites and generally include a broad set of features encompassing the entire life cycle of a Clinical Trial Study. It starts from Planning the Study, Recruitment, Site and CRO Management, Randomisation, Protocol Compliance, Document repository and Finances Management.
Direct Competitors: Firms offering decentralised CTMS and EDC solutions for web and mobile devices.
Cloud BYZ Decentralised Clinical Trial Solutions
Realtime Clinical Trial Management Systems
Crucial Data Solutions' TrialKit Platform
Advarra's Clinical Conductor, a Decentralised Clinical Trial Management product
Indirect Competitors: Firms offering a traditional centralised suite of SaaS products, including CTMS, EDC solutions and more only for Web browsers.
Veeva Digital Trials Platform: Vaults CTMS, Vault EDC
BSI CTMS and EDC
SimpleTrials
Intrinsic Clinical Systems CTMS
3. Problem Statement
GreenEra Pharmaceuticals is an organisation that works in Pharma research and drugs mass-production business. They have a big team of scientists who research and develop formulas for multiple medicines related to different diseases and conditions yearly.
Process:
1. Clinical Trial
Stage 1 (20 patients)
Stage 2 (300 patients)
Stage 3 (4500 patients)
2. Regulator Approval 3. Production
Pain Points:
The existing process takes place on paper, making it very difficult for the team of scientists to
Call patients every day
collect data
analyse data
Prioritisation Scope for MVP version:
Digitise the entire clinical trial to the regulatory approval process
Deliverables
1. A simple platform for patients to record
medicine quantity
time of medicine administration
2. Dashboard for the scientist's team
to get a clear picture of the overall trial
view individual patient data
4. System Design
After understanding the complete ecosystem of SaaS solutions for clinical trials, the System design solutions will overlap the most crucial features from the following set of products.
Decentralised Clinical Trial Management System (DCTMS)
Clinical Data Management System (CDMS)
Electronic Data Capture (EDC)
eCRF and eConsent Tools
The product design solution 'Safe Trials' is a mobile-first experience for Patients and Scientists of Clinical Research. The App will access and store data from a decentralised cloud-based clinical Data Management System. The CDMS becomes one source of truth for Sites, CROs, Sponsors and Patients participating in the Clinical trial. It will curb data duplication and enhance the data accuracy of the system.
Why a mobile-first experience?
A mobile experience for Patients has been chosen because of the high number of users having access to mobile phones. Also, mobile devices have proved to be the most efficient in sending notifications and reminders to study participants to comply with Protocol remotely.
A mobile device for RnD scientists will allow quick access to relevant information from a Cloud-based clinical Data Management System without sitting in front of desktop computers.
5. Ideate: Patient App
User Journey
Wireframes
6. Ideate: Scientist App
User Journey
Wireframes
View Scientist's App Wire Frames on Figma.
7. Hi-Fidelity Mockups
🔥 You can View the Figma file with the design solution here: Safe Trials App.
Design System
Components: Customised UI components have been used from the latest Material Design 3 System.
Typography: Circular Std Font with Type scale and spacing defined by Material Design 3 System.
UI Design
View Patient's App Hi-Fi Mockups on Figma.
View Scientist's App Hi-Fi Mockups on Figma.
8. Next Steps
I solved the problem statement within a time box of 3 days. Hence, with two more days of time, the following steps would need to be completed following the Google Design Sprint template.
Interactive Prototypes
Moderated User Testing / Task Scenario testing with five clinical trial participants and scientists.
Synthesise User Testing findings into themes and derive actionable insights.
Incorporate these findings in Hi-Fi Mockups.
What could be done with more time?
Smartwatch experience to enhance the Patients App.
Feature to notify participants about upcoming doctor appointments, time of medications and record daily medication log.
Fitness tracking data from smartwatches can be attached to the Case Report Form and made accessible to the patient detail page in the Scientists App.
Web browser experience to enhance the Scientist's App.
Web Browser will provide a better experience to Scientists while working on Clinical trial report documents.
Web Browser experience will allow scientists to dive into data sheets and analyse infographics on a more comfortable larger screen with more real estate.
Admin and Executive level dashboard for Safe Trials Scientist's App.
Resources
Google Material 3 Design System: https://m3.material.io/
Illustrations: https://www.freepik.com/
Tools: Figma + FigJam, Notion, Penultimate
Thanks for reading! You can also listen to this article on my medium blog. :)
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