clinilink

Bridging the data gap within clinical trials

Honourable mention🏅for the REDESIGN: Women's Health Hackathon

Overview

Historically, clinical trials have underrepresented women,
leading to significant gaps in gender-specific data. This results in medical treatments and interventions that are often not optimized for women, potentially causing less effective or unsafe outcomes.

Historically, clinical trials have underrepresented women,
leading to significant gaps in gender-specific data. This results in medical treatments and interventions that are often not optimized for women, potentially causing less effective or unsafe outcomes.

Goal

Goal

Goal

To bridge the gender data gap in clinical trials by increasing female representation and collecting gender-specific health data to ensure treatments are safe and effective for all genders.

To bridge the gender data gap in clinical trials by increasing female representation and collecting gender-specific health data to ensure treatments are safe and effective for all genders.

Outcome

Outcome

Outcome

A B2B service that supports pharmaceutical companies, healthcare providers, and researchers. Additionally, an inclusive B2C service that empowers women with personalized health information and access to clinical trials that consider gender-specific needs, leading to improved treatment outcomes.

Key stakholders

Key stakholders

Key stakholders

  • Female participants for clinical trials

  • Pharmaceutical companies

  • Healthcare providers

  • Researchers

  • Regulatory Bodies

Year

Year

2024

2024

Duration

Duration

2 day hackathon

2 day hackathon

Category

Category

Hackathon

My Role

My Role

Service & User experience designer

Service & User experience designer

Team

Team

Service designer & 3 Biomedical engineering students

Service designer & 3 Biomedical engineering students

Keywords

Healthcare, women's health, gender gap awareness, user centered design, B2B B2C service

“For millennia, medicine has functioned on the assumption that male bodies can represent humanity as a whole. […]

Women are dying, and the medical world is complicit.
It needs to wake up.”

Criado Perez, C. (2019) ‘The drugs don’t work’, in nvisible Women: Data Bias in A World Designed for Men. London, Great Britain: Penguin Random House UK, pp. 215–216.


Criado Perez, C. (2019) ‘The drugs don’t work’, in nvisible Women: Data Bias in A World Designed for Men. London, Great Britain: Penguin Random House UK, pp. 215–216.


An analysis of over
3.2 million participants across 768 clinical trials found that
only 38% were women.

An analysis of over
3.2 million participants across 768 clinical trials found that
only 38% were women.

An analysis of over
3.2 million participants across 768 clinical trials found that
only 38% were women.

GHDx Gender Inequalities in Clinical Research Report 2022


Barriers leading to underrepresentation of women
and minorities in clinical trials

Participation of women in clinical trials faces multiple interconnected challenges at systemic, individual, and structural levels.

  • Systemically, issues like gender bias, historical exclusion, and limited awareness of how clinical trials impact women create an environment where many women are either unaware of or excluded
    from participation.

  • On a personal level, factors such as mistrust, financial constraints, and competing life responsibilities further discourage women.

  • At the core are the trial design barriers, which stem from the way clinical trials are structured. Inefficient recruitment strategies and restrictive eligibility requirements further reduce accessibility and participation, particularly for underrepresented groups.

    Addressing these barriers requires tackling the root causes across all levels to foster inclusion and participation.

From the experts…

From the experts…

From the experts…

Interviews with healthcare industry experts and women in participating in clinical trials gave deeper insights into the current state of the trials.

Interviews with healthcare industry experts and women in participating in clinical trials gave deeper insights into the current state of the trials.

" Current solutions lack
empathy, data quality
and have a big drop
out rate."

— Dr Shikta Das, AstraZeneca

" Participants face societal
barriers both in terms of
gender and ethnicity."

— Linh Nguyen, Clinical trial participant &
Product Manager at a healthcare firm

from Insights to Hypothesis…

Based on the insights from the current tool, a hypothesis was developed to address the identified challenges and improve user engagement through more effective interaction and measurement

We believe that :

We believe that :

We believe that :

we can :

we can :

we can :

As a result, we will see :

As a result, we will see :

As a result, we will see :

Re-defining the brief

How might we design a humanized, intuitive, and efficient impact measurement tool that:

  • Empowers service users to engage meaningfully and reflect on their experiences,

  • Enables service providers to have access to more nuanced data for informed decision-making, and

  • Provides commissioners with clear, measurable insights to demonstrate the impact and value of their services.

Ideation

The ideation phase was about understanding the purpose behind each and every question in the 'Infinity assessment', reconstructing it and brainstorming new and accessible ways to approach the assessment.

Dissecting the
current assessment

Brainstorming

Brainstorming

Brainstorming

Sorting & classifying

Sorting & classifying

Sorting & classifying

Feasibility & Co- Creation
workshops with practitioners

The infinity assessment questionnaire is divided according to the 4 strands that Catch22 caters to:
Family & significant others, Lifestyle & associates, Emotional Wellbeing and Social Inclusion.

After brainstorming and sorting ideas for the new impact measurement toolkit, I facilitated and executed a co-creation workshop. We used methods like feasibility mapping to position ideas against organizational constraints, ensuring the ideas were practical and impactful.

The Big idea :

Evaluating growth through conversations

The premise of the solution is that evaluation happens through conversation. It now accounts for growth and change throughout the service journey, giving the service user an increased sense of control and self-awareness.

This solution reimagines evaluation as a dynamic and user-centric process, seamlessly integrated into the service journey. By shifting the focus from rigid measurement systems to fostering conversations, the design emphasizes growth, adaptability, and a deeper connection with the service user.

Experience: The improved journey

The data is recorded in a digital format simultaneously using Excel and PowerBI(curently Catch22 uses this)

What's new?

Guiding principles: Data recording

Reframing the questions for catch-ups

To enhance the effectiveness of catch-ups, the original Infinity Assessment, which featured rigid, lengthy, and overly wordy questions, was re-evaluated.

To enhance the effectiveness of catch-ups, the original Infinity Assessment, which featured rigid, lengthy, and overly wordy questions, was re-evaluated.

Identifying Patterns: Cognition, Willingness, and Ability

Through ideation, a pattern emerged that these questions primarily focused on cognition, willingness, and ability.

This realization led to the redesign of catch-up questions, making them more engaging, concise, and easy to understand.

The new format encourages more meaningful and productive conversations while ensuring the collection of accurate and relevant data

Identifying Patterns: Cognition, Willingness, and Ability

Through ideation, a pattern emerged that these questions primarily focused on cognition, willingness, and ability.

This realization led to the redesign of catch-up questions, making them more engaging, concise, and easy to understand.

The new format encourages more meaningful and productive conversations while ensuring the collection of accurate and relevant data

e.g.: a question from the' infinity assessment'

Data analysis principle

Reframing the questions for catch-ups

To measure the recorded data, the toolkit highlights a layered evaluation process where Journal Progress, a self-initiated activity, supports the Formative Catch-Ups by providing ongoing documentation and insights into individual growth.

The Formative Catch-Up, including the First Catch-up and the De-brief and Final Catch-Up, are facilitated sessions that build on this progress, offering structured feedback and guidance.

This process ensures continuous learning and reflection, while the rewarding system for extra credits motivates additional engagement and effort. Together, these components form a cohesive system for development and evaluation.

To measure the recorded data, the toolkit highlights a layered evaluation process where Journal Progress, a self-initiated activity, supports the Formative Catch-Ups by providing ongoing documentation and insights into individual growth.

The Formative Catch-Up, including the First Catch-up and the De-brief and Final Catch-Up, are facilitated sessions that build on this progress, offering structured feedback and guidance.

This process ensures continuous learning and reflection, while the rewarding system for extra credits motivates additional engagement and effort. Together, these components form a cohesive system for development and evaluation.

Rewarding principle

The power of small gestures

The 'Rewarding Principle' visualizes how motivation and value addition align with Maslow’s Hierarchy of Needs to enhance engagement and productivity.

This principle was shaped by insights from practitioners, who emphasized that even small gestures or moments of recognition significantly impact service users’ morale and motivation. Recognizing this, we introduced the rewarding system to foster a sense of achievement, inspire motivation, and introduce healthy competition.


The intervention addresses basic needs like respect, trust, and belonging, and progresses toward self-identity and personal goals, ultimately driving self-actualization. By combining recognition with tailored motivational strategies,
the system empowers individuals, enhances well-being, and fosters
sustainable growth.

The toolkit:
How does the service user and practitioner
use the toolkit?

The toolkit enhances collaboration between service users and practitioners through:

  • Progress Journal - Tracks improvement with journey mapping, phased goals, and a reward system.


  • Catch-up Forms - Facilitates structured check-ins using measurable, scenario-based questions.


  • Intervention Form - Gathers non-verbal data through observations during interventions.

The forms are in physical paper format due to restrictions on carrying electronic devices in certain situations. Additionally, using a laptop during meetings can
be distracting.

The data from these forms can later be scanned and entered into the system.

The forms are in physical paper format due to restrictions on carrying electronic devices in certain situations. Additionally, using a laptop during meetings can
be distracting.

The data from these forms can later be scanned and entered into the system.

How is the new toolkit creating value
for the key stakeholders?

But what are the systemic constraints we are operating with and the systemic pushbacks we might encounter?

Introducing the new toolkit may encounter systemic constraints and pushbacks rooted in organizational culture and capacity. These include resistance to change due to entrenched systems, regulatory compliance burdens, and the significant time, effort, and resources required for adoption. Distrust in the system and weak faith in its ability to deliver meaningful outcomes may also lead to reluctance or
forced engagement.

Theory of Change

The Theory of Change outlines how meaningful measurement can drive positive outcomes for Catch 22.
By adopting an empathetic approach to data collection, fostering a sense of control through co-created goals, and emphasizing motivation and visible progress, the toolkit aims to shift perceptions, improve engagement, and reduce negative outcomes like prison recalls and drop-outs. This approach empowers service users, builds trust, and ensures measurable impact, aligning with the broader vision of fostering behavior change and enhancing the organization’s efficiency and value creation.

And lastly, testing the toolkit with practitioners...

Testing and validating the toolkit involved collaborating with practitioners due to limited access to service users.
The process was carried out across 3 probation facilities of Catch22, ensuring its relevance and effectiveness in real-world settings.

Feedback and learnings